Danny McAuley on behalf of the REVIVE Royal Victoria Hospital and Queen s University of Belfast

Transcription

1 The REVIVE study A multi-centre RCT of the effect of a programme of exercise on physical function in survivors of critical illness after hospital discharge Danny McAuley on behalf of the REVIVE Royal Victoria Hospital and Queen s University of Belfast Critical Care Cananda Forum October 2015

2 None Disclosures

3 REVIVE study team K McDowell B O Neill B Blackwood S Murphy JM Bradley NI Clinical Trials Unit Evie Gardiner, Statistican C Clarke P Johnston M Kelly J McCaffrey B Mullan J Trinder G Lavery

4 Problems after critical illness Physical Problems Pain Fatigue Reduced mobility Diminished cardiac & respiratory reserve Muscle weakness Disuse atrophy Reduced physical function Restricted activities of daily living Reduced exercise capacity Poor appetite Malnutrition Voice & taste changes Problems with swallow Non-Physical Problems Anxiety & depression ICU-associated delirium Relocation stress Mood changes Sleeping difficulties Irritability Poor concentration Lower health related quality of life Post Traumatic Stress Disorder Reduced social functioning Cognitive dysfunction Increased healthcare medical costs Burden on families & carers O Neill B, McAuley DF. Sequelae and rehabilitation after critical illness. Clinical Medicine 2011;11:

5 Hypothesis Does a 6-week programme of exercise in patients discharged from hospital following critical illness compared to standard care improve outcome

6 Objectives To investigate the effectiveness of the programme of exercise on physical function and exercise capacity health-related quality of life psychological morbidity self-efficacy to exercise To determine the feasibility (safety, practicality and acceptability) of the exercise programme To explore patient s perceptions of the exercise programme To examine the medium-term (6 months) effects

7 REVIVE trial design Phase 2 trial Multi-centre 6 hospitals in Northern Ireland, UK Randomised, allocation concealed Outcome assessment blinded O Neill B et al. Trials 2014;15:146

8 REVIVE trial design Baseline (Weeks 0-2 post hospital discharge) Standard Care 6 week exercise programme Primary outcome assessment Assessment (6 months) Semi-structured interview

9 Population Age 18 years Inclusion Criteria ICU admission requiring mechanical ventilation > 96 hrs Exclusion Criteria Declined consent or unable to give consent Neurological dysfunction affecting ability to exercise Planned discharge to home (selfcare/carer) Significant cognitive impairment Willing and able to participate in exercise intervention Participation in another rehabilitation programme due to ongoing chronic disease Medically fit to take part in the intervention

10 Intervention 3 exercise sessions per week for 6 weeks (2 supervised,1 unsupervised) Delivered by physiotherapist Supervised sessions were hospital-based (or participant s home if not possible) Standardised exercises, tailored to the each individual participant Strategies to optimise fidelity of the delivery of the intervention

11 Intervention

12 Intervention

13 Outcome Measures Primary Outcome Measure: Physical function SF-36 Physical Functioning subscale Secondary Outcome Measures: Physical function Exercise capacity Health-related quality of life Self-efficacy to exercise Readiness to exercise Anxiety, Depression Rivermead Mobility Index (RMI) Incremental Shuttle Walk Test (ISWT) Functional Limitations Profile (FLP) SF-36 (subscales & component scores) Chronic Disease Self-efficacy Scale Readiness to Change Hospital Anxiety & Depression Scale (HADS)

14 Statistical Analysis Sample size n=52 with primary OM at 6 weeks Analysis Intention to treat analysis

15 1118 Assessed for eligibility 293 Died 765 Excluded 566 Did not meet criteria Participation in other structured rehab (236) Not medically fit for the intervention (143) Neurological/spinal/skeletal dysfunction (85) Cognitive impairment (71) Not discharged to home (31) 125 Declined 23 Unable to contact 51 Other 60 Randomised 30 Intervention group 30 Control group 26 included in analysis for primary outcome (6 weeks) 3 Unable to contact 1 Withdrew consent 29 included in analysis for primary outcome (6 weeks) 1 Hospital inpatient

16 Baseline characteristics Intervention Control Age - years 51 (13) 51 (14) Male 13 (43) 21 (70) ICU diagnosis Respiratory Cardiovascular Gastrointestinal Neurological Trauma Genito-urinary Other 17 (56.7) 4 (13.3) 3 (10) 2 (6.7) 2 (6.7) 1 (3.3) 1 (3.3) 13 (43.3) 4 (13.3) 6 (20) 3 (10) 3 (10) 0 (0) 1 (3.3) APACHE (7.7) 15.2 (5.6) Duration mechanical (269.8) (235.8) ventilation hours Length of stay ICU days 17.6 (15.3) 18.2 (11.7) Length of stay Hospital days 35.7 (26.0) 39.5 (22.6)

17 SF-36 Physical Functioning at 6 weeks SF-36 Physical Functioning intervention control baseline 6 weeks p=0.26

18 Incremental Shuttle Walk Test at 6 weeks Incremental Shuttle Walk Test intervention control baseline 6 weeks p=0.03

19 SF-36 Role Physical at 6 weeks SF-36 Role Physical intervention control baseline 6 weeks p=0.02

20 Functional Limitations Profile at 6 weeks Functional Limitations Profile intervention control baseline 6 weeks p=0.02

21 Chronic Disease Self Efficacy Scale at 6 weeks Chronic Disease Self Efficacy Scale intervention control baseline 6 weeks p=0.01

22 Other outcomes at 6 weeks Intervention Control p-value Rivermead Mobility Index SF-36 PCS SF-36 MCS Readiness to Exercise 1.3 (2.1) 1.1 (1.8) (7.8) 5.8 (13.6) 3.2 (6.7) 1.1 (13.1) (0.97) (0.96) <0.001 HADS Anxiety HADS Depression (3.6) -1.2 (4.4) 0.18 (3.3) 0.36 (3.1)

23 Delivery and feasibility Adherence 77% Duration Location Delivery Safety 7.6 (1.7) weeks 81% attended hospital gym for all supervised sessions Home visits necessary for 5 participants on at least one occasion Primarily one to one One unexpected related SAE

24 SF-36 Physical Functioning at 6 months SF-36 Physical Functioning intervention control baseline 6 months 6 weeks p=ns

25 Incremental Shuttle Walk Test at 6 months Incremental Shuttle Walk Test intervention control baseline 6 months 6 weeks p=ns

26 SF-36 Role Physical at 6 months SF-36 Physical Functioning intervention control baseline 6 months 6 weeks p=ns

27 Functional Limitations Profile at 6 months Functional Limitations Profile intervention control baseline 6 months 6 weeks p=ns

28 Chronic Disease Self Efficacy Scale at 6 months Chronic Disease Self Efficacy Scale intervention control baseline 6 months 6 weeks p=ns

29 Patient s perceptions of the exercise programme Semi-structured interviews Interview schedule including supplementary prompts Carried out by researcher not involved in the delivery of the intervention or blinded outcome assessment All interviews were audio recorded and transcribed verbatim Analysis Thematic content analysis of interview transcripts

30 Semi structured interview - Results Themes The detrimental impact of critical illness and reflections on the critical care journey Satisfaction and endorsement of the programme of exercise Beneficial impact of the programme of exercise Facilitators of beneficial impact Barriers to beneficial impact Continuing exercise after the programme and factors that impacted on this The quantitative outcome measures

31 Semi structured interview - Results The detrimental impact of critical illness and reflections on the critical care journey You know, the nightmares, the dreams I ve had, and, really, really frightening like, I still waken, crying, dreaming, you know and different things happening But um when I approached my GP after, he was very dismissive and I think it was just genuinely through not enough knowledge. He had no idea he just basically said to suck it up and get on with it, you know which is not what you want to hear.

32 Semi structured interview - Results The quantitative outcome measures Many of these themes were not captured in the quantitative OMs

33 Conclusion Exercise rehabilitation initiated after discharge from hospital following critical illness No significant difference in the primary outcome measure (SF-36 PF) Significant improvements demonstrated in patientreported and performance based outcomes at 6 weeks Feasible, safe and acceptable Not sustained at 6 months Need to determine dose regimen for future studies Need to define outcomes

34 Acknowledgements This project was supported by REVIVE HSC R&D Division, Public Health Agency in NI

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