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Rehabilitation Training After Stroke (ReTrain)

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ClinicalTrials.gov Identifier: NCT02429180
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
The Stroke Association, United Kingdom
Information provided by (Responsible Party):
University of Exeter

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).

Condition or disease Intervention/treatment Phase
Stroke Other: Rehabilitation Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Community-based Rehabilitation Training After Stroke: a Pilot Randomised Controlled Trial
Actual Study Start Date : July 31, 2015
Actual Primary Completion Date : January 27, 2016
Actual Study Completion Date : January 27, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Rehabilitation training

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

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.

No Intervention: Control
Control: treatment as usual plus receipt of a UK Stroke Association booklet on exercise after stroke.



Primary Outcome Measures :
  1. Change in Rivermead Mobility index [ Time Frame: Baseline, 6 months, 9 months ]
    15-item, dichotomously scored measure of mobility disability. Fourteen items are self-report and one (standing for 10s without aids) is scored by observation

  2. Change in Timed Up and Go Test [ Time Frame: Baseline, 6 months, 9 months ]
    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

  3. Change in Modified Patient Specific Functional Scale [ Time Frame: Baseline, 6 months, 9 months ]
    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

  4. Change in Physical Activity Diary [ Time Frame: Baseline, 6 months, 9 months ]
    Participants record the type of activity and its duration each day of the week (1-2 minutes per day to complete).

  5. Change in Physical activity - 7-day accelerometry [ Time Frame: Baseline, 6 months, 9 months ]
    Worn by individual to assess physical activity behaviour over seven days. Should take 5 minutes to fit watch and 10 minutes to post back


Secondary Outcome Measures :
  1. Fatigue Assessment Scale [ Time Frame: Baseline, 6 months, 9 months ]
    10-item self-completion questionnaire in which aspects of fatigue are rated on how regularly they are experienced, using a 5-point scale

  2. Stroke Self-efficacy Questionnaire [ Time Frame: Baseline, 9 months ]
    10-item questionnaire in which participants rate their confidence in completing some tasks that may have been difficult for them since their stroke

  3. Exercise beliefs questionnaire [ Time Frame: Baseline, 9 months ]
    Measures attitudes to exercise by rating levels of agreement to 5 statements about what it can achieve for the individual.

  4. Exercise self-efficacy questionnaire [ Time Frame: Baseline, 9 months ]
    Self-rating of confidence to overcome 4 personal barriers to exercise

  5. Stroke Quality of Life [ Time Frame: Baseline, 9 months ]
    Self-rating of twelve dimensions of lifestyle and personal functioning

  6. EQ-5D-5L [ Time Frame: Baseline, 9 months ]
    Measuring health-related quality of life and can be used for cost utility analysis

  7. SF-12 46 [ Time Frame: Baseline, 9 months ]
    Abbreviated version of the Short-Form-36 self-completion questionnaire measuring health-related quality of life. It can also be used to calculate the SF-6D, which may be used for cost utility analysis.

  8. Service Receipt Inventory [ Time Frame: Baseline, 9 months ]
    Record of types and amount of use of health and social care resources including medication, clinical contacts, formal and informal social care. Completed by Assessor drawing on participant and family accounts, and clinical records if available.

  9. Carer Burden Index [ Time Frame: Baseline, 9 months ]
    Carers of stroke survivors rate the difficulties and challenges of providing care

  10. Adverse incidents [ Time Frame: 6 months, 9 months ]
    Adverse events


Other Outcome Measures:
  1. The type and frequency of health and allied services measured using an adapted Client Service Receipt Inventory based on the TRACS study [ Time Frame: 0-9 months ]
    Collection of service use data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • <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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429180


Locations
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United Kingdom
University of Exeter Medical School
Exeter, Devon, United Kingdom, EX1 2LU
Sponsors and Collaborators
University of Exeter
The Stroke Association, United Kingdom
Investigators
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Study Chair: Sarah Dean, PhD University of Exeter Medical School
Study Director: 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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT02429180    
Other Study ID Numbers: CRF192
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases