Chapter 3: Methodology

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1 Chapter 3: Methodology STUDY DESIGN A Randomized Controlled Trial STUDY SETTING The present study was carried out in 4 old age homes in Mangalore and nearby regions. TARGET POPULATION Elderly subjects, aged 65 years and older, of either gender. SAMPLE SIZE AND SAMPLE METHOD The sample size was calculated using a ready reckoner table 92, anticipating A score of 4.5 BBS points as the Minimum Important Difference (MID) 93 for all the groups. An expected standard deviation of 5 each. Intraclass correlation coefficient of 0.3 with 3 repeated measures Significance level of 5% and a power of study of 80% 10% dropout for each group Based on the above assumptions the sample size derived was 54 elderly subjects; 3 groups of 18 each. Methodology Page 52

2 SAMPLING METHOD The subjects' who gave consent [appendix-1], underwent medical screening [appendix- 2] and screening for inclusion and exclusion criteria. The eligible subjects were assigned to the study groups by sequence generation performed by block randomization. Block size of 6 was used in the trial to allocate the participants to the three study groups i.e. each block consisted of 2 PRT, 2 TBE and 2 COMBI interventions. The allocation concealment was done using sealed opaque envelopes which were sequentially arranged. INCLUSION CRITERIA The following criteria were used to include the subjects for this study: 1. Subjects aged 65 years and older, of both gender 2. Elderly subjects screened by the physician [appendix-2] 3. Subjects included for the study had a BBS score 41 to 52. The lower cut off of 41 BBS score was kept to exclude subjects who were considerably frail 94 and at risk of falls Researchers found a mean total score of 52.6 on BBS among nonfallers, 98 and therefore, the upper cut off for inclusion was kept as 52 BBS points. 4. Subjects with a minimum score of 23 on Mini Mental State Examination (MMSE) were included for the study. A score of 23 or more was chosen to ensure that the subjects were mentally competent to perform the exercise safely, comprehend and respond appropriately to the tests and questionnaires used as outcome measures. 60,99 5. FRT score of more than 17.5 cm (7 inches) 100,101 Methodology Page 53

3 6. Minimum muscle strength of 4/5 on Medical Research Council (MRC) grade for the lower extremity muscle groups (key muscles). 102,103 EXCLUSION CRITERIA 1. Symptomatic cardiovascular disease, 2. Neurological conditions like stroke and Parkinson s disease known to interfere with gait and balance, 3. Significant dorsal column sensory loss in lower extremities, 4. Any musculoskeletal condition of the lower quarter which could interfere with the intervention or outcome measures 5. Cancer (metastatic or under active treatment), 6. Prescription medications which carry the risk of causing falls, 7. Subjects with history of hernia and abdominal aortic aneurysm, 8. Diagnosed with vestibular disorders and 9. Subjects who underwent lower limb strength training and/or balance training during the past 3 months. TESTER The tester or investigator was a qualified physical therapist, pursuing PhD in the field of Physiotherapy. The recording of each outcome measures (BBS, FRT, WHOQOL-BREF, and FES) was blinded and was performed by an independent observer (qualified physiotherapist) who was familiar with the administration of the measurement tools. Methodology Page 54

4 STUDY PERIOD From June 2008 to Dec 2013 INSTRUMENTS 1. Screening check list [appendix-2] 2. MMSE [ appendix-3] including a blank paper, pen or pencil and a watch 3. BBS [appendix-4] including a stool of standard height, chair with arm rest, step of standard height (15cm), watch with a seconds hand, a pencil or pen and a wooden measurement scale [Fig.1] 4. FRT [appendix-5], including leveled wooden measurement scale mounted on a wall using double sided adhesive tape and a plumb line [Fig.1] 5. FES, a self-confidence scale for fear of fall (English and Kannada versions) [appendix-6] 6. World Health Organization Quality of Life-Brief (WHOQOL-BREF) - English and Kannada versions [appendix-7] 7. Foam mattress of 3-4 thickness with length of 6.5 feet and width of 3 feet [Fig.1] 8. Standard treatment plinth 9. Sand bags [Fig.2] of varying weights ranging from 250gm to 5kgs (250gm- 1 piece, 500gm-2 pieces, 1kg- 2 pieces, 1.5kg-1piece, 2kgs- 2pieces, 3kgs-1piece and 5kgs 1piece) 10. Medium size Gym or Swiss ball [Fig.1] 11. Chalk pieces [Fig.1] Methodology Page 55

5 Fig. 1 Study materials- Swiss ball, foam mattress, wooden measurement scale, double sided adhesive tape, plumb line, pen and chalk pieces Fig. 2 Sandbags of different weights Methodology Page 56

6 PROCEDURE The study commenced after the approval given by the institutional research and ethics committees [appendix-8], following which the investigator prepared the list of old-age homes, based on district administration and corporation registers within and around Mangalore (South Karnataka, India) region. The investigator personally approached and discussed the research project with 12 old age home authorities, of which 8 old age homes agreed to conduct the study among the inmates. Out of the 8 old age homes, four centers were excluded. Reasons for exclusion of these centers were presence of regular physical therapy exercise program including balance training for the inmates and predominance of mentally challenged and distressed elderly. For the remaining homes, with the permission of the authorities a concise explanation of the study was given to the care takers and inmates of the old age home and later, the list of interested participants was obtained. Written informed consent was collected from all the interested subjects, who were then subjected to medical screening. The medical screening was performed by a qualified medical practitioner from Kasturba Medical College, Mangalore using the screening check list [appendix-2]. Based on the medical screening, suitable subjects were identified. Following the above, an independent and blinded observer administered the BBS [Fig.3-9], FRT [Fig.10-11], manual muscle testing and MMSE [appendix-3] on the Methodology Page 57

7 identified subjects. Those who scored in BBS, 17.5 cm or above for FRT, 4 or above grade muscle power for the key muscles and 23 or above in MMSE were included for the study. In addition to above, the blinded independent observer administered the FES and WHOQOL-BREF (English and Kannada versions) to those subjects who fulfilled the inclusion criteria. The baseline values were recorded and preserved for data analysis. To get the sample size of 54, a total of 268 subjects from 4 different old age homes were screened. The participants were not blinded to the allocated treatment and the study was an outcome assessor blinded trial. The PRT group received resistance training for the key muscles of both lower extremities. DeLormes and Watkins protocol was used for the PRT group, and each exercise session lasted for approximately an hour. The muscle groups strengthened were hip flexors, extensors and abductors, knee flexors, and extensors, and ankle dorsiflexors and plantar flexors. The PRT group subjects were instructed to raise or lift a weight (concentric muscle action) within 1-2 seconds and then lower the weight (eccentric muscle action) within 2-3 seconds. A rest period of 1 second between movements and 30 seconds to a minute between sets were given. Methodology Page 58

8 Fig. 3 Subject performing sit to stand (without hand support) for BBS Fig. 4 Subject performing sit to stand (with hand support) for BBS Methodology Page 59

9 Fig. 5 Subject performing standing with feet together for BBS Fig. 6 Subject performing retrieving the object for BBS Methodology Page 60

10 Fig. 7 Subject performing turning to look behind (right side) for BBS Fig. 8 Subject performing turning to look behind (left side) for BBS Methodology Page 61

11 Fig. 9 Subject performing placing alternate foot on the step for BBS Fig. 10 Subject keeping the feet shoulder width apart (confirmed by the plumb line passing from lateral aspect of acromion to lateral border of the foot) for FRT Methodology Page 62

12 Fig. 11 Subject performing functional reach test Methodology Page 63

13 The hip flexors were strengthened in high sitting near the edge of the treatment plinth [Fig.12]. Hip abductors were given strength training in side-lying [Fig.13] and for hip extensors and knee flexors [Fig.14,15]; the training was in prone lying. Knee extensors and ankle dorsiflexors were given strength training in sitting [Fig.16,17]. The strength training for ankle plantar flexors was performed while the subject was standing with hands held on the back rest of the chair, window rails or foot-end rail of the treatment plinth [Fig.18]. The resistance (sand bag) was secured to the distal part of the leg in the above mentioned positions. However, for ankle dorsiflexors, the sand bag was secured around the foot. The starting positions used for strengthening the key muscles were also deployed for determining the 1 RM, for the respective muscle group. Brzycki's equation 107,108 was used to determine Max load or 1RM for each muscle group and equation used is as follows: 1 RM = Weight [ ( Number of repetitions)] The number of repetitions was based on the following criteria: 1. Inability to continue lifting the weight. 2. Subject reporting tiredness or fatigue while lifting the weight 3. Deterioration in the performance such as reduction in the active ROM or presence of trick movements or compensations to achieve the full ROM 4. Consuming longer time than required to execute the movement 5. Taking undue rest in between the movement repetitions. Methodology Page 64

14 DeLorme and Watkin s PRT exercise protocol for each muscle group consisted of: 1 st Set: 10 times of ½ of 10RM 2 nd Set: 10 times of ¾ of 10RM and 3 rd Set: 10 times of 10RM In order to ensure that the training program was progressive and structured in nature, the 1-RM tests were conducted every 2 weeks 109 and the training weight was adjusted accordingly. To avoid the possibility of undue fatigue and tiredness, the test for 1RM (every 2 weeks) were performed on rest days. Similarly, to minimize musculoskeletal injuries, the subjects were given 15RM (65% of 1RM) instead of prescribed 10RM of DeLormes and Watkins protocol during the first four weeks. 110 The TBE group (control group) received traditional or conventional balance exercise for approximately 45 minutes. Traditional balance exercises consisted of 8 components and they were weight-shifts, standing on one leg, tandem walking, crossover walking (braiding), figure of eight walking, forward, backward and sideways walking on foam, sitting balance on a medium size Swiss ball and perturbations of balance in all directions while sitting on plinth, foam and Swiss ball [Fig.19-25]. Based on the ability of the participant, the complexity of the balance training was increased. A rest period of 1 minute was given between each component. The COMBI group received PRT and TBE alternately, thus making 2 days of PRT and 2 days of TBE in a week. The strengthening and balance training procedure received by COMBI group was identical to the exercise regimen of PRT and TBE groups. Methodology Page 65

15 Fig. 12 Strength training using sandbag for hip flexors in sitting position Fig. 13 Strength training using sandbag for hip abductors in side lying position Methodology Page 66

16 Fig. 14 Strength training using sandbag for hip extensors in prone position Fig. 15 Strength training using sandbag for knee flexors in prone position Methodology Page 67

17 Fig. 16 Strength training using sandbag for knee extensors in sitting position Fig. 17 Strength training using sandbag for ankle dorsiflexors in sitting position Methodology Page 68

18 Fig. 18 Strength training using sandbag for ankle plantar flexors in standing position Fig. 19 Weight shifts (reach out activity) in standing Methodology Page 69

19 Fig. 20 Single leg standing Fig. 21 Tandem walking Methodology Page 70

20 Fig. 22 Crossover walking (braiding) Fig. 23 Forward walking on a foam mattress Methodology Page 71

21 Fig. 24 Maintaining independent sitting on the Swiss ball Fig. 25 Perturbations given while sitting on the Swiss ball Methodology Page 72

22 Subjects of all the three groups were given respective exercises four times a week for a period of six months. The exercise programs for all the study groups were given strictly under supervision of the investigator or an assistant, who was a graduate physical therapist, proficient with the exercise protocols for each group. All the subjects irrespective of the group were encouraged to perform to their best capability at all times including the test for 1RM calculation. The details of the subjects, the exercise regimen, the progression and adverse events were routinely entered on the subject s log book. At the end of 3rd and 6th month the blinded outcome assessor re-assessed the outcome measures and recorded these for data analysis. Most of the subjects who received strength training program for the PRT and COMBI groups had a few days of delayed onset muscle soreness (DOMS), and were symptomatically treated with reassurance and/or thermal agents, for a day or two. However, 2 subjects of the PRT group and 3 of the COMBI group had considerable aggravation of arthritic joint pain and refused to continue the exercise program and were omitted from this study [Fig. 26]. The number of sets of resistance training and the position of sand bag (resistance) were modified for those subjects who had worsening of arthritic pain or DOMS. Similarly, subjects who felt uneasy, or lacked desire to perform the exercises on the designated day, were exempted from exercises on the same day, but the exercises were given on the subsequent rest day. For those who had less than three episodes of acute illness, the period of intervention was accordingly extended. Methodology Page 73

23 Obtained permission from eight old age homes Four old age homes included for study Excluded=4 old age homes Reason for exclusion: a) Presence of regular physical therapy exercise program including balance training b) Predominance of mentally challenged and distressed elderly. Written informed consent N=268 Medical Screening Screening for inclusion and exclusion criteria Block Randomization (N=54) N=54 Excluded = 214 Reasons for exclusion: Use of walking aids, FRT <7, muscle power <4, MMSE <23, symptomatic cardiovascular disease, neurological conditions like stroke and Parkinson s disease, diagnosed vestibular disorders etc. PRT (N=18) TBE (N=18) COMBI (N=18) Baseline outcome measures Dropout (2); Aggravation: 2 Dropout (2); Aggravation: 1 Left home: 1 Dropout (5); Aggravation: 1 Refusal: 2 Left home: 1 Death: 1 PRT (N=16) TBE (N=16) COMBI (N=13) 3 rd month outcome measures PRT (N=16) TBE (N=16) COMBI (N=13) 6 th month outcome measures Fig. 26 Flow chart of subjects enrollment, allocation and analysis Methodology Page 74

24 STATISTICAL ANALYSIS Data was entered into Microsoft excel and quality was checked by random verification of 10% of the entered data. All statistical analysis was performed using SPSS ver15 (SPSS South Asia, Bangalore). Categorical data was summarized using frequency with percentages. Continuous data was summarized using mean and standard deviation for normally distributed data and median with inter-quartile range for skewed data. Comparison of baseline characteristics of the three groups was carried out using one way ANOVA for the continuous variables and chi square test for the categorical variables. Repeated measures ANOVA was used for comparison of outcome measures over time between the three groups. The change scores (pre-post intervention) was analyzed using Kruskal Wallis test followed by Mann-Whitney U test adjusted for alpha error for pairwise comparison. The analysis was performed using both per-protocol and intention to treat. A p-value of less than 0.05 was considered as statistically significant. Methodology Page 75

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