FES-Rowing Cardiorespiratory Studies

Transcription

1 FES-Rowing Cardiorespiratory Studies Participant Information Pack The effect of functional electrical stimulation-assisted rowing on cardiorespiratory function in persons with spinal cord injury Brunel University Centre for Sports Medicine and Human Performance Heinz Wolff Building Kingston Lane Ubridge Middlese UB8 3PH Tel:

2 Participant Information Pack The effect of functional electrical stimulation-assisted rowing on cardiorespiratory function in persons with spinal cord injury Contents 1 Introduction page 3 2 Functional Electrical Stimulation page FES-Rowing page Who can FES-Row? page Why FES-rowing? page 4 3 The FES-Rowing Cardiorespiratory Studies page Study Groups - FES-Trained vs. FES-Untrained page FES-Training Studies page Pre-Study Evaluation page Stage 1: Inclusion and eclusion criteria page Stage 2: Pre-study Consultation page 8 Motor point test page 8 Possible side effects page Stage 3: GP / Spinal Consultant Consultation page 9 4 Tests, Scans & Incremental Eercise Tests page Introduction page FES-Untrained Control Group page FES-Trained Group page Visit 1 page 12 Blood test page 12 Possible side effects page 12 Cardiac ultrasound scans page 12 Possible side effects page 12 1

3 Vascular ultrasound scans page 12 Possible side effects page 13 Respiratory tests page 13 Possible side effects page Visit 2 page 14 Arm-crank eercise test page 14 FES-rowing eercise test page 15 Possible side effects page 15 5 FES-Training Programme page Introduction page FES-Training page Phase 1: FES-Leg Conditioning page Phase 2: Integrated FES-Rowing page Phase 3: Final 8 Weeks FES-Training page 17 Possible side effects page Training Logs page 17 FES-rowing Cardiorespiratory Study Consent Form page 19 2

4 1 Introduction This information pack has been written to provide a comprehensive background for people interested in the FES-Rowing Cardiorespiratory Studies which are being conducted at Brunel University. These studies have been set up to identify if changes to the heart, blood vessels and respiration take place in a person with a spinal cord injury (SCI) following a programme of functional electrical stimulation (FES)-rowing training. 2 Functional Electrical Stimulation Functional Electrical Stimulation is a technique used to produce contractions in paralysed muscles by the application of small pulses of electrical stimulation to nerves that supply the paralysed muscle. The stimulation, delivered via non-invasive electrodes, is controlled in such a way that the movement produced provides useful function. As such, FES can be used as a means of practicing functional movements for therapeutic benefit in activities such as cycling and rowing. 2.1 FES-Rowing An Odstock Medical 4-channel muscle stimulator and electrodes FES-rowing combines voluntary upper body eercise with electrically stimulated lower body eercise which enables a person with a SCI to row in a similar way to a non-disabled rower using both arms and legs. This has been made possible with an FES-rowing device which has been developed at Brunel University. The present Brunel FES-rowing prototypes can only be used in research studies under approved university ethics committee approval for both participant protection and liability cover. Although these devices are not commercially available, a prototype CE marked FESindoor rowing device is under development. A large part of the CE marking process involves gathering sufficient clinical evidence of the equipment s efficacy which the FES-Rowing Cardiorespiratory Studies will help to provide. In addition, we are also in the process of developing a low cost home based device. 2.2 Who can FES-Row? FES-rowing has proven to be a well tolerated training modality that is currently being enjoyed 3

5 by both men and women over the age of 18 with complete spinal cord injuries ranging from cervical vertebrae 4/5 (C4/5) to thoracic vertebrae 12 (T12). The limitation in high SCI is the ability to arm fle; the limitation in low level SCI is the lack of a response to electrical stimulation. The only other limitation is in individuals with preserved sensation who may find electrical stimulation uncomfortable or even intolerable. Participants need to be at least recreationally active to be trained to FES-row, a process that takes approimately 16 weeks. The following four FES rowers shown below illustrate the diversity of people that can FESrow. The age refers to the age when the rower completed the training programme. Ale 25 (C5 incomplete) Josh 18 (C4/5 complete) Soraya 45 (T4 complete) Tom 23 (T12 complete) 2.3 Why FES Rowing? FES-rowing has been the subject of over 15 years research into finding an activity, intense enough, to help prevent the so called diseases of inactivity such as coronary artery disease, type II diabetes, and obesity in people with SCI. Brunel University has taken the initiative of widening the evidence base for FES-rowing by investigating the cardiorespiratory adaptations that are believed to result from this form of training. Cardiorespiratory diseases are now responsible for the highest mortality rate in the general population. The people most at risk are those who live a sedentary lifestyle which dramatically affects cardiorespiratory fitness; people with a spinal cord injury form a subset of this population due to the inactivity imposed by life in a wheelchair. In the general population, research has shown that significant improvements in cardiorespiratory fitness and reduced incidence of the diseases of inactivity are conferred through an appropriate eercise programme. 4

6 One of the research prototype FES-rowing machines at Brunel University Although eercise training has been shown to benefit people with SCI, this population is typically restricted to eercise of the upper body. The small muscle mass involved in upper limb eercise however, means that people with SCI are unable to sustain high levels of aerobic eercise, and in addition are placed at increased risk of muscle and joint overuse type injury. An inability to eercise hard enough or long enough results in a reduced training stimulus, which may eplain why peak oygen uptake and cardiac output in people with SCI are considerably lower than the values reported in the general population. Research conducted on FES-rowing to date suggests that far higher levels of fitness and improved general health are possible with this form of eercise than with any other type of eercise currently available; providing the necessary time is committed to the training. In addition, a number of peripheral benefits appear to result including improved circulation and bone mineral density, stabilisation of upper body joints, reduced susceptibility to overuse type injuries, and natural control of body weight in a safe and more sustainable way. 5

7 3 The FES-Rowing Cardiorespiratory Studies 3.1 Study Groups: FES-Trained vs. FES-Untrained The FES-Rowing Cardiorespiratory Studies have been set up to study the effect of FESrowing training on the cardiorespiratory function of people with SCI. We are recruiting volunteers for two participant groups: 1. SCI FES-trained 2. SCI FES-untrained Participants in the two groups will have their cardiorespiratory function compared at rest and under eercise conditions. We will attempt to match these two groups for age, se, size, level of injury, completeness of injury and time post-injury. The SCI FES-trained group will be taken through a 16 week FES-rowing training programme. The SCI FES-untrained group will serve as the control group for the studies. 3.2 FES-Training Studies The FES-training studies have been set up to investigate the time course to cardiovascular and respiratory adaptation in people with a SCI and establish the most appropriate intensity for optimum health benefits in this population. Both participant groups will initially undergo a simple blood test for blood cholesterol levels and a comprehensive set of non-invasive cardiovascular scans and respiratory tests at rest and under eercise conditions (see section 4 Tests, Scans and Incremental Eercise Tests on page 11). Any possible side effects of an activity or test will be discussed and highlighted in blue italic print following the section to which it refers. Volunteers that are not being FEStrained will be re-tested following a 16 week period of habitual eercise (see section 4.2 FES- Untrained SCI group on page 11). People volunteering for an FES-training study will undergo the 16 week FES-training programme (see section 4.3 FES-Trained SCI Group on page 11). Repeat cardiovascular scans and respiratory tests will be made at key stages in the training programme to identify when any cardiorespiratory changes take place. Medical cover will be provided by an in-house medical professional whilst participating in the FES-Rowing Cardiorespiratory Studies. In addition, volunteers for an FES-training study will be provided with all the equipment necessary to FES-train whilst engaged on a study. We will also make a contribution to travel epenses for all participants on a basis of distance travelled and the number of visits to the university. We are also in the process of making arrangements for participants who have completed a 16 week FES-training study to continue FES-rowing. However, participants should be aware that they will need to purchase their own muscle stimulators at this point. These devises can be purchased at cost price through Brunel University from the National FES Centre based at Salisbury District Hospital. In addition, all consumables that are required to FES-row can also be purchased at cost price through Brunel University. Participants wishing to commit to this on-going phase of training will be re-tested at 6, 12 and 18 months after their FES-training study so we may better understand the effect habitual long term FES-training is having. 6

8 3.3 Pre-Study Evaluation To ensure participant safety, inclusion in the FES-Rowing Cardiorespiratory Studies will be determined by successful completion of the following pre-study evaluation stages. All volunteers will complete Sage 1 Inclusion and Eclusion Criteria (see below) and Stage 2 Pre-Study Consultation (see page 8) to determine their suitability for participation in a study. In addition to the first two stages, volunteers recruited for an FES-training study will also undergo Stage 3 GP / Spinal Consultant Consultation (see page 9). This is an independent assessment by a family GP or Spinal Consultant in the case of volunteers newly discharged from hospital. It will be assumed that all participants are at least recreationally active and, if volunteering for an FES-training study, not currently using FES. 3.4 Stage 1: Inclusion and Eclusion Criteria The research nature of the FES-Rowing Cardiorespiratory Studies dictates strict inclusion and eclusion criteria to ensure participant safety and to comply with university ethics to cover liability issues. As such all inclusion and eclusion criteria will be strictly adhered to. The following criteria apply as indicated: Inclusion criteria - Both SCI groups: Se: male or female. Age: 18 to 45 years of age. At least recreationally active. Able to eercise on an arm-crank eercise machine for up to 15 minutes. Able to provide a good quality echocardiogram. American Spinal Injury Association (ASIA) classification A (complete motor and sensory) or B (complete motor and incomplete sensory). Lesion stable as determined by neurological eamination. Lesion level: C4/5 (able to fully fle both arms) to T12 (able to respond to electrical stimulation). Discharged from hospital with full cognitive abilities. Minimum of 12 months post-injury providing no known medical complications. In-date medication for autonomic dysrefleia especially SCI s T6 and above. Inclusion criteria - SCI FES-trained group: GP or Spinal Consultant approval following consultation. Positive response to electrical stimulation. Able to demonstrate safe transfer from wheelchair to FES-rowing machine. Able to commit to strenuous 16 week FES-rowing training programme. Eclusion criteria - Both SCI groups: Known medical complications (hypertension, cardiac dysfunction, cardiac or respiratory disease, uncontrolled arrhythmias, uncontrolled angina, congestive heart failure, current deep venous thrombosis, severe non-insulin dependent diabetes) or any medical contra-indications as identified by a GP or physician. Cardiac medication prescribed and or required. Cardiac pacemaker fitted and or required. Smoker. Social drug user. 7

9 Eclusion criteria - SCI FES-trained group: Use of FES assisted eercise prior to a study. Participation in whole-body eercise regime. Medication that severely limits eercise intensity (e.g., Baclofen). Eercise limited by severe spasticity. Eercise limited by range of motion in hips, knees or ankles. Eercise limited by severe autonomic dysrefleia. Eercise limited by electrical stimulation. Severe skin reactions to electrical stimulation. Individuals that fulfil the inclusion criteria and who wish to volunteer to participate in the FES- Rowing Cardiorespiratory Studies should contact Robin Gibbons on or fes@brunel.ac.uk to arrange Stage 2 the Pre-Study Consultation. 3.5 Stage 2: Pre-Study Consultation People wishing to volunteer to take part in the FES-Rowing Cardiorespiratory Studies will undergo a pre-study consultation in the Indoor Athletics Centre at Brunel University. During this consultation, participation in a study will be openly discussed and any questions or concerns addressed. Volunteers will also be asked to take a short health questionnaire to ensure there are no health-related issues that would place an individual at unnecessary risk. On successful completion of the pre-study consultation, volunteers in the FES-untrained group will be asked to sign the Pre-Study Consultation Consent form on page 19 of this information pack and their initial test date will be confirmed. During the Pre-Study Consultation, volunteers for an FES-training study will undergo an additional test. This test, called a motor point test, is used to confirm a person can be stimulated using a small electrical current. Motor point test: A motor point test involves placing small 7 cm diameter adhesive electrodes on the front and rear of the thighs, as illustrated in the image below. These electrodes are connected to a small 9-volt muscle stimulator. When the channels are sequentially switched on, a small electrical current stimulates the nerves supplying each muscle group. If the muscle can be stimulated in this way, it will contract and may even move the associated limb. Position of the electrodes on the front and rear thighs A positive response is required of both quadriceps and hamstring muscle groups. These muscle groups etend and fle the legs enabling a person with a SCI to FES-row. Heart rate will be monitored throughout using a Polar heart rate monitoring belt worn around the torso 8

10 which transmits a signal of heart rate to a receiver. Blood pressure will be monitored before, during and after the test with an electronic Omron blood pressure monitor and cuff. This will establish any susceptibility an individual has to autonomic dysrefleia. In addition, volunteers will be asked to completely void their bladders prior to the test to avoid an unnecessary autonomic response. Possible side effects: Individuals with complete spinal cord injuries will feel no sensation from this level of electrical stimulation. However, individuals who have preserved sensation may find the stimulation uncomfortable, or even intolerable. In addition, individuals with spinal cord injuries above T6 may eperience a headache and or sweating and flushing of the skin above the level of their SCI due to dysfunction of their autonomic nervous system. Cessation of the electrical stimulus will resolve this autonomic response within 1 to 2 minutes. It is also usual to see slight reddening of the skin on removal of the electrodes; this is due to increased blood flow to the skin with FES. This response is harmless and will resolve within minutes of electrode removal. Following a successful pre-study consultation, volunteers for an FES-training study will be asked to contact their GP or Spinal Consultant (in the case of SCI volunteers recently discharged from hospital) to arrange a consultation where they can independently and impartially discuss the potential risks of participating in an FES-training study. A GP / Spinal Consultant Information Sheet will be given to applicants volunteering for an FES-training study. This information sheet should be taken to the consultation with the family GP or Spinal Consultant. 3.6 Stage 3: GP / Spinal Consultant Consultation: The GP or Spinal Consultant consultation is to ensure the safety of people wishing to volunteer for an FES-training study and as such, the appropriateness of inclusion in the studies. There are no absolute contraindications to using FES to assist eercise although there are neurological limitations which are related to an individual s level of SCI as previously discussed on page 4 of this information pack. However, volunteers for an FEStraining study should be aware of the potential risks of using FES-assisted eercise and manage those risks appropriately. The following issues should be discussed with the family GP or Spinal Consultant: The risk of pressure sores and skin marking from sitting on a different surface and / or transferring on and off the rowing machine. Participants are required to check and report their skin condition especially in contact areas after every FES-training session; knees and ankles when FES leg conditioning and back, shoulders, backside and lower legs when FES-rowing. This in addition to observing NHS skin care management recommendations which will have been discussed by an individual s spinal consultant and specialist skin viability nurse. Whilst individuals with a SCI at or above T6 are taught to recognise the symptoms of autonomic dysrefleia and where necessary self-treat this condition, they should be aware that FES can cause this. Participants that are susceptible to this neurological response or who have a SCI at or above T6 are to ensure they have a supply of in-date Nifedipine medication with them during a motor point test and if included in a study, all subsequent FES-training sessions. Some participants may eperience an increase in muscle spasms or neuropathic pain 9

11 and should be aware of this. Adequate range of motion at hips, knees and ankles is required in order to FES-row safely and effectively. Potential participants must be able to achieve full etension and fleion of both knee joints in addition to a normal range of motion in hip and ankle joints. FES-rowing is a high intensity eercise therefore the usual precautions in uncontrolled diabetes and coronary heart disease apply. Transfer on and off the FES-rowing machine is a potential risk. Participants are to strictly observe current NHS guidelines and recommendations whenever transferring. There is risk of low trauma fracture in individuals with osteoporosis. Potential participants are strongly recommended to be referred for a bone mineral density DEXA scan prior to joining an FES-training study if there is a concern that a significant risk of osteoporosis eists in the lower limbs. FES-rowing is not suitable for individuals who have incomplete sensory function who find the stimulation uncomfortable or even intolerable. It is also not suitable for individuals who suffer from severe autonomic dysrefleia. In addition it is not suitable for individuals with high-level lesions who cannot voluntarily fully fle their arms, or for individuals with low-level lesions who show no response to electrical stimulation. Although FES-rowing has been used routinely in long term studies for over 5 years and has been studied in scientific projects for almost 15 years, to date, no known specific complications have been identified. However, as more people are becoming involved, it is possible that some side effects or complications may become apparent. As safety is our prime consideration, participants are asked to report any medical complications or adverse events that they may encounter to the supervising research investigator as soon as possible. On successful completion of the GP or Spinal Consultant consultation, volunteers for an FES-training study should counter-sign the GP / Spinal Consultant consent form on page 4 of the GP / Spinal Consultant Information Pack. Volunteers for an FES-training study should then sign the Pre-Study Consent Form on page 19 of this information pack and contact Robin Gibbons at Brunel University on or fes@brunel.ac.uk to arrange a convenient start date. As the consent forms are only valid for 6 months, any participant still engaged on a study will be asked to give their informed consent by signing subsequent consent forms. 10

12 4.1 Introduction 4 Tests, Scans & Incremental Eercise Tests All participants volunteering for the FES-Rowing Cardiorespiratory Studies will initially visit Brunel University to undergo a simple blood test for blood cholesterol levels, a comprehensive set of cardiac and vascular ultrasound scans and respiratory tests and a 12 to 15 minute arm-crank eercise test. People that wish to volunteer for an FES-training study will form the FES-trained group and people who do not wish to volunteer for an FES-training study will form the FES-untrained control group. 4.2 FES-Untrained Control Group Participants that do not wish to volunteer for an FES-training study will be asked to log their normal eercise habits over a 16 week period (see section 5.6 Training Logs on page 17). They will then be re-tested. This group will act as the control group for the FES-training studies. 4.3 FES-Trained Group Participants who do wish to volunteer for an FES-training study will be asked to log their normal eercise habits over an initial 4 week period in addition to all daily eercise they are involved in during their 16 week FES-training study (see section 5.6 Training Logs on page 17). Following the initial 4 week period, the ultrasound scans and respiratory tests will then be repeated. The initial 4 week period will identify any short-term effect a person s normal habitual eercise is having. The participants in an FES-training study will then start their FES-training programme which takes approimately 16 weeks. During the training programme participants will undergo repeat ultrasound scans and respiratory tests at key stages in the programme to identify any cardiorespiratory adaptations the training is having. These tests will include a 12 to 15 minute arm-crank incremental eercise test as well as an FES-rowing incremental eercise test once a participant is able to non-stop row. Participants are required to refrain from the following before being tested: 1. Eating a large meal on the day of testing. 2. Food for 12 hours prior to the blood test. 3. Consumption of caffeine within 12 hours of testing. 4. Consumption of alcohol within 24 hours of testing. 5. Vigorous activity within 48 hours of testing. 6. Wearing clothing that substantially restricts full chest and abdominal epansion. Any possible side effects of an activity or test will be discussed following the relevant section to which it relates and will be highlighted in blue italic print. The full set of tests and scans will be taken over two separate visits to the university. 11

13 4.4 Visit 1 Blood test: A small blood sample will be taken from one of the large veins on the front of the forearm following a 12 hour overnight fast and 48 hours abstinence from any vigorous activity. The blood sample is required for the subsequent determination of high, low and total blood cholesterol concentrations. Possible side effects: Participants will eperience slight pain during the initial pinprick, but this will resolve within seconds. Slight bruising may also be eperienced, but this will not be painful. Cardiac ultrasound scans: Resting measures of cardiac structure and function will be assessed non-invasively using a standard ultrasound system using echocardiography. We are primarily interested in the left ventricle, as it is this chamber of the heart that is responsible for pumping blood around the body. Ultrasound enables us to measure heart overall function including muscle wall thickness and the contraction and relaation function of the muscle wall. Mid-chest scanning position Lower left chest scanning position There are two sites on the chest where we can image this part of the heart; one is mid chest slightly to the left of the breast bone, and the other is towards the lower left chest area. Please see the images above. The scanning procedure requires the use of a water based gel to enhance the ultrasound image. In view of these issues, and in the interests of modesty, female participants will be given a loose fitting top to wear. There is a fully disabled-friendly changing room with a toilet adjacent to the scanning room for participants to use. Although this assessment is being conducted by a male researcher, he will only be present whilst conducting the scanning procedures. A female chaperone will be present throughout and will help or assist with changing as required. It is also perfectly acceptable for female participants to bring a chaperone of their own if they would be more comfortable with this arrangement. In addition, it should be clearly understood that if any participant becomes uncomfortable with the procedure, they are free to stop the eamination at any time. Possible side effects: Ultrasound scanning is completely harmless and non-invasive with no known side effects. The main risk is the ability to transfer safely on and off the scanning plinth. SCI participants will have to demonstrate the ability to transfer safely using current NHS guidelines and recommendations. Vascular ultrasound scans: The first of three vascular ultrasound assessments involves recording resting measures of 12

14 the vascular structure of the carotid artery in the neck, brachial artery in the arm and common and superficial femoral arteries in the upper leg using a non-invasive high resolution ultrasound machine. Please see the images below for the upper thigh scanning positions. In the second and subsequent vascular assessment, only the brachial and common femoral arteries will be scanned. In this assessment baseline vascular function will be measured using a forearm and thigh inflatable cuff which will be placed above the brachial and femoral artery being scanned. Initial ultrasound resting measures will be made of artery diameter blood flow for 1 minute before the cuffs are inflated. The cuffs will remain inflated for 5 minutes during which time blood flow will be temporarily stopped. On cuff deflation, the resultant dilation of the artery will be recorded. Imaging will continue for a further 5 minutes post cuff deflation. Common femoral artery Superficial femoral artery Upper thigh scanning positions: The third vascular assessment will assess the maimal functional capacity of the brachial and femoral arteries to increased blood flow again using the forearm and thigh inflation cuff. Following resting measures for 1 minute, the cuffs will be inflated for 13 minutes once again temporarily stopping blood flow. On cuff deflation, the resultant maimal dilation of the artery will be recorded. Imaging will again continue for 5 minutes post cuff deflation. As with the cardiac scans, the vascular scanning procedure uses a water-based gel to enhance the ultrasound image. In view of these issues, and again in the interests of modesty, participants will be given loose fitting shorts to wear. Once again, although these assessments are being conducted by a male researcher, he will only be present whilst conducting the scanning procedures. As before, a female chaperone will be present throughout and will help or assist with changing as required. It is also perfectly acceptable for a female participant to bring a chaperone of her own if she would be more comfortable with this arrangement. In addition, it should be clearly understood that if any participant becomes uncomfortable with the procedure, they are free to stop the eamination at any time. Possible side effects: Ultrasound scanning is non-invasive and completely safe to use. However, the inflation cuffs can cause a sensation similar to pins and needles in individuals with preserved sensation. This sensation is temporary and resolves completely on cuff release. Respiratory tests: All respiratory tests are non-invasive. Diaphragm thickness will be measured by 2D ultrasound. Please see the image below which shows the diaphragm scanning position. Lung 13

15 function will be assessed by blowing into a mouthpiece that is connected to a computer. The computer will analyse the volume of air that is breathed in and out as well as how quickly the air can be moved with each blow. We will also measure the maimum inspiratory and epiratory muscle strength using a small portable mouth pressure meter. In addition, we will assess respiratory health and function using two standard respiratory questionnaires. 4.5 Visit 2 Diaphragm scanning position on the torso Possible side effects: During the respiratory tests, participants may eperience a slight popping of the ears and or slight loss of colour vision or seeing stars during some of these tests due to the relatively high respiratory pressures being generated volitionally against an eternal resistance. However, these effects are completely harmless and will resolve themselves within minutes after performing the tests. Arm-crank eercise test: Following a standardised warm-up and familiarisation with the equipment, all participants will complete a continuous incremental eercise test on an arm-crank eercise machine to collect cardiorespiratory data under eercise conditions. This will enable us to determine maimum oygen uptake. Oygen uptake refers to the rate at which an individual uses oygen when eercising. The oygen used and carbon dioide produced will be measured via a mouthpiece connected to a gas analyser. Please see the image on page 15 which illustrates this equipment. The continuous incremental eercise test, which typically takes 12 to 15 minutes to complete, comprises 1 minute stages to volitional ehaustion. The power required at each stage will be incrementally increased until it is not possible to complete the final stage. The initial power and subsequent power increases will be based on se and level of spinal cord injury. This will enable us to identify the peak cardiorespiratory response to this form of eercise. During the eercise test, blood lactate will be measured at rest, immediately on completion of the test then every 2, 4, 6, and 8 minutes after the test is completed to determine peak eercise intensity. This involves a small pin pick on an earlobe to etract an etremely small sample of blood at each of the times indicated above. Heart rate will be measured continuously using a Polar heart rate belt worn around the torso which transmits a signal of heart rate to a receiver. Blood pressure will be recorded before and immediately after the eercise test using an electronic Omron blood pressure monitor and cuff. In addition, arterial oygen saturation - that is the concentration of oygen in the blood - will be recorded noninvasively using a device attached to an earlobe. 14

16 FES-rowing eercise tests: Participants volunteering for an FES-training study will also undergo an incremental FESrowing eercise test once they are able to non-stop row. This test will be conducted in a similar fashion to the arm-crank eercise test detailed above enabling us to compare the respiratory data collected from the two eercise modalities. Typical gas analysing equipment Possible side effects: Participants will eperience slight pain during the initial pinprick, but this will resolve within seconds. Slight bruising may also be eperienced, but this will not be painful. Participants may eperience temporary fatigue and shortness of breath during the eercise tests. However, these sensations will resolve within minutes of completing the test. 15

17 5.1 Introduction 5 FES-training Programme The FES-training programme will be run at Brunel University, West London. The programme has been developed by Brunel researcher Robin Gibbons who suffered a SCI himself in January It has undergone continuous evaluation and development and is based on training protocols that have evolved over the last 5 years with medical advice from a spinal consultant and physiotherapists at the Royal National Orthopaedic Hospital, North London. 5.2 FES-Training There are two components to the training: FES-leg conditioning and FES-rowing. The programme is split into three distinct phases. Participants will start with Phase 1 FES-leg conditioning. Once participants legs are sufficiently conditioned they will begin Phase 2 where FES-rowing is integrated into the programme. Phase 3 comprises the final 8 weeks of full FES-training. 5.3 Phase 1: FES Leg-Conditioning Initial FES-leg conditioning will be conducted under the supervision of Robin Gibbons at Brunel University. Training starts with quadriceps-only conditioning which can be conducted whilst sitting in a wheelchair or while laid prone on a bed providing the lower legs can hang freely with gravity. The aim is to achieve alternate knee etensions on alternate days, 3 times per week with training sessions gradually building to 60 minutes in duration. FES-Leg Conditioning using the Odstock Medical 4-channel stimulator When participants are competent to conduct this training unsupervised, they will be loaned a stimulator to carry out FES-leg conditioning at home. During home based training, participants will only be required to visit the university once a week to assess progress or when integrating hamstring conditioning. Hamstring conditioning will be integrated once 10 minutes of alternate knee etensions are possible. During this phase, with no joint or muscle contraindications, eercise volume will be increased to daily sessions of up to 60 minutes in duration when not FES-rowing. However, once alternate knee etensions are possible for at least 30 minutes, FES- 16

18 rowing will be integrated into the training programme. 5.4 Phase 2: Integrated FES-Rowing All FES-rowing training is conducted at Brunel University. Participants typically start with an interval training regime whereby they FES-row for 30 seconds followed by an arms-only row for 30 seconds. This interval training regime is repeated for as long as possible or on reaching 30 minutes. The FES-rowing component of the interval training regime increases until the participant is able to non-stop FES-row for 30 minutes. During this phase, the aim is to complete 3-30 minute centre based non-stop FES-rowing sessions every week whilst conducting the 4-60 minute FES-leg conditioning sessions at home. 5.5 Phase 3: Final 8 weeks FES-training This level of training then continues for a further 8 weeks when participants on an FEStraining study will undergo their final cardiovascular scans and respiratory tests. All training equipment and consumables will be provided whilst participating on an FES-training study. It is essential that a training programme is conscientiously followed for inclusion in the FES- Rowing Cardiorespiratory Studies findings. FES-rowing using the DEMAND adapted Concept 2 Indoor Rowers Possible side effects: During the training programme, participants will undergo a progressive increase in the volume and intensity of eercise during their training. This will be especially so once FES-rowing is integrated into the training. Participants will eperience fatigue and shortness of breath. These sensations are a normal response to this form of training and are a necessary part of increasing cardiorespiratory fitness. They will resolve within minutes of completing a training session. 5.6 Training Logs Volunteers in both participant groups will be asked to log all high-energy physical activity during the course of their study using pre-prepared training logs. In addition, subjects participating in the FES-trained group will also be asked to log all their weekly FES-training. Baseline health data will also be collected every 4 weeks for the FES-trained group on preprepared health data forms. Both forms will be supplied on commencement of the study. 17

19 It should be emphasised participation in a study is strictly voluntary and that participants should understand that they are free to withdraw from a study at any time without having to give a reason. Think you may be interested? If you think you may be interested in volunteering to take part in the FES-Rowing Cardiorespiratory Studies, please contact: Robin Gibbons on or fes@brunel.ac.uk.. 18

20 FES-Rowing Cardiorespiratory Studies Consent Form Participants should complete the whole of this form themselves Have you read the FES-Rowing Cardiorespiratory Studies Participant Information Pack? Have you had an opportunity to ask questions and discuss this study? Please sign the appropriate bo YES NO Have you received a satisfactory answer to all your questions? Who have you spoken to? Do you understand that you will not be referred to by name in any scientific report or presentation concerning these studies? Do you understand that you are free to withdraw from these studies: at any time? without having to give a reason for withdrawing? If necessary, do you agree for information to be given to your GP? Do you agree to take part in these studies? Research volunteer: Date:.. Name in capitals: Witness statement: I am satisfied that the above named has given informed consent. Witnessed by: Date:. Name in capitals: This consent form is valid for 6 months. Renewal / End date:... 19