Rehabilitation Training After Stroke

NCT02429180 | Completed Phase 1 DMC

• 1 other identifier: CRF192
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of ReTrain (which would assess the clinical and cost effectiveness of ReTrain for stroke survivors).

Conditions

Stroke

Outcome Measures

Primary Outcomes (5)

• Change in Rivermead Mobility index

  15-item, dichotomously scored measure of mobility disability. Fourteen items are self-report and one (standing for 10s without aids) is scored by observation

  Baseline, 6 months, 9 months

• Change in Timed Up and Go Test

  Objective measure of mobility, balance and locomotor performance, in which the individual is observed and timed rising from a chair, walking 3m, turning and returning to the chair

  Baseline, 6 months, 9 months

• Change in Modified Patient Specific Functional Scale

  Identification by individual of up to five functional tasks that are important and difficult to perform, and rating of ability to perform each task on a 0-10 scale

  Baseline, 6 months, 9 months

• Change in Physical Activity Diary

  Participants record the type of activity and its duration each day of the week (1-2 minutes per day to complete).

  Baseline, 6 months, 9 months

• Change in Physical activity - 7-day accelerometry

  Worn by individual to assess physical activity behaviour over seven days. Should take 5 minutes to fit watch and 10 minutes to post back

  Baseline, 6 months, 9 months

Secondary Outcomes (10)

• Fatigue Assessment Scale

  Baseline, 6 months, 9 months

• Stroke Self-efficacy Questionnaire

  Baseline, 9 months

• Exercise beliefs questionnaire

  Baseline, 9 months

• Exercise self-efficacy questionnaire

  Baseline, 9 months

• Stroke Quality of Life

  Baseline, 9 months

Other Outcomes (1)

• The type and frequency of health and allied services measured using an adapted Client Service Receipt Inventory based on the TRACS study

  0-9 months

Study Arms (2)

Rehabilitation training

EXPERIMENTAL

ReTrain: an exercise-based functional training programme comprising two phases: (1) weekly supervised sessions; (2) monthly drop-in sessions, plus home-based exercise in each phase. * Week 1: one-to-one consultations with trainer to introduce programme, assess individual's concerns and capabilities, introduce and negotiate initial goals * Weeks 2-11: bi-weekly 90 minute group class with group-based activities and one-to-one coaching, based on ongoing goal negotiation review and progression. * Week 12: one-to-one consultations with trainer to review goals and plan ongoing unsupervised exercise programme * Weeks 13-24: monthly drop-in sessions for one-to-one consultation, support and progression.

Other: Rehabilitation

Control

NO INTERVENTION

Control: treatment as usual plus receipt of a UK Stroke Association booklet on exercise after stroke.

Interventions

Rehabilitation OTHER

ReTrain: an exercise-based functional training programme comprising two phases: (1) weekly supervised sessions; (2) monthly drop-in sessions, plus home-based exercise in each phase. * Week 1: one-to-one consultations with trainer to introduce programme, assess individual's concerns and capabilities, introduce and negotiate initial goals * Weeks 2-11: bi-weekly 90 minute group class with group-based activities and one-to-one coaching, based on ongoing goal negotiation review and progression. * Week 12: one-to-one consultations with trainer to review goals and plan ongoing unsupervised exercise programme * Weeks 13-24: monthly drop-in sessions for one-to-one consultation, support and progression.

Rehabilitation training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary clinical diagnosis of stroke (assessed by referring clinician/GP records)
• \>1 month (but no upper limit) since discharge from NHS physical rehabilitation services at randomisation
• Able to walk independently indoors with or without mobility aids, but has self-reported difficulty or requires help on stairs, slopes or uneven surfaces (assessed by recruiting team using standard tools)
• Willingness to be randomised to either control or ReTrain (and attend the training venue)
• Cognitive capacity and communication ability sufficient to participate in the study (assessed by recruiting team using standard tools).24 NB: Criterion (3) has been selected pragmatically to maximise eligibility while ensuring participants have a mobility deficit that could be addressed by the intervention. Eligible people with aphasia will not be excluded.

You may not qualify if:

• \<18 years old
• Contraindications to moderate to vigorous physical activity. Used in GP screening assessment form. (Adapted from ACSM guidelines 25) Contraindications include:
• Acute or uncontrolled heart failure
• Unstable or uncontrolled angina
• Uncontrolled cardiac dysrhythmia causing symptoms or haemodynamic compromise
• Symptomatic severe aortic stenosis
• Current deep vein thrombosis, pulmonary embolus or pulmonary infarction
• Acute myocarditis or pericarditis
• Suspected or known dissecting aneurysm
• Unstable / uncontrolled blood pressure
• Systolic blood pressure \> 160
• Diastolic blood pressure \> 100
• Acute systemic infection
• Uncontrolled diabetes

Sponsors & Collaborators

• University of Exeter: lead
• The Stroke Association, United Kingdom: collaborator

Study Sites (1)

University of Exeter Medical School

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (6)

• Taylor E, Soilemezi D, Urquhart DS, Cunningham S, Lewis S, Neilson AR, Ensor H, Vogiatizis I, Allen L, Saynor ZL; ExACT-CF study group. Exploring Exercise as Airway Clearance in Cystic Fibrosis: A Qualitative Study From the ExACT-CF Feasibility Trial. Pediatr Pulmonol. 2026 Jan;61(1):e71470. doi: 10.1002/ppul.71470.

  PMID: 41587390 DERIVED

• Hollands L, Calitri R, Warmoth K, Shepherd A, Allison R, Dean S; ReTrain Trial; team. Assessing the fidelity of the independently getting up off the floor (IGO) technique as part of the ReTrain pilot feasibility randomised controlled trial for stroke survivors. Disabil Rehabil. 2022 Dec;44(25):7829-7838. doi: 10.1080/09638288.2021.1998672. Epub 2021 Nov 12.

  PMID: 34767488 DERIVED

• Norris M, Poltawski L, Calitri R, Shepherd AI, Dean SG; ReTrain Team. Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial. Trials. 2019 Aug 23;20(1):525. doi: 10.1186/s13063-019-3633-8.

  PMID: 31443735 DERIVED

• Norris M, Poltawski L, Calitri R, Shepherd AI, Dean SG; ReTrain Team. Acceptability and experience of a functional training programme (ReTrain) in community-dwelling stroke survivors in South West England: a qualitative study. BMJ Open. 2018 Jul 25;8(7):e022175. doi: 10.1136/bmjopen-2018-022175.

  PMID: 30049699 DERIVED

• Dean SG, Poltawski L, Forster A, Taylor RS, Spencer A, James M, Allison R, Stevens S, Norris M, Shepherd AI, Landa P, Pulsford RM, Hollands L, Calitri R. Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility. BMJ Open. 2018 Feb 15;8(2):e018409. doi: 10.1136/bmjopen-2017-018409.

  PMID: 29449290 DERIVED

• Dean SG, Poltawski L, Forster A, Taylor RS, Spencer A, James M, Allison R, Stevens S, Norris M, Shepherd AI, Calitri R. Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain). BMJ Open. 2016 Oct 3;6(10):e012375. doi: 10.1136/bmjopen-2016-012375.

  PMID: 27697876 DERIVED

Related Links

• Action for rehabilitation after neurological injury
• PenCLAHRC

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sarah Dean, PhD

  University of Exeter Medical School

  STUDY CHAIR

• Rod Taylor, Prof

  University of Exeter Medical School

  STUDY DIRECTOR

• Anne Forster, Prof

  University of Leeds

  STUDY DIRECTOR

• Anne Spencer, Prof

  University of Exeter Medical School

  STUDY DIRECTOR

• Martin James, Dr

  Royal Devon and Exeter NHS Foundation Trust

  STUDY DIRECTOR

• Rhoda Allison, Dr

  Torbay & Southern Devon Health & Care Trust

  STUDY DIRECTOR

• Shirley Stevens, Mrs

  PenPIG

  STUDY DIRECTOR

• Meriel Norris, Dr

  Brunel University

  STUDY DIRECTOR

• Leon Poltawski, Dr

  University of Exeter Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 29, 2015
• Study Start: July 31, 2015
• Primary Completion: January 27, 2016
• Study Completion: January 27, 2016
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

GB (1)