PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study

NCT03492957 | Completed

• 1 other identifier: SHLS1
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to design a physical activity programme for non-ambulatory stroke survivors (delivered via either community-based groups or a home-based individual programme) and evaluate its feasibility, acceptability, preliminary and adverse effects. The study will also explore the views of non-ambulatory stroke survivors and their carers on: needs, personal goals, barriers, and motivators, experiences of programme participated in and preferred format (i.e. home-based individual/ community-based groups).

Conditions

Stroke

Keywords

physical activity; exercise; non-ambulatory; feasibility; mixed methods

Outcome Measures

Primary Outcomes (1)

• Canadian Occupational Performance Measure (COPM)

  Person-centred tool for goal setting and evaluation

  3-month follow-up

Secondary Outcomes (8)

• Barthel Index (BI)

  3-month follow-up

• Stroke Impact Scale (SIS)

  3-month follow-up

• Stroke Self-Efficacy questionnaire (SSEQ)

  3-month follow-up

• Hospital Anxiety and Depression Scale (HADS)

  3-month follow-up

• Motricity Index (MI)

  3-month follow-up

Study Arms (1)

Physical activity

EXPERIMENTAL

A tailored, person-centred, 12-week, chair-based exercise intervention to increase physical activity and fitness. Dose: one face-face session with a qualified physiotherapist plus two independent sessions per week. This is combined with education on self-management, self-efficacy and lifestyle change. There is no control group ion this feasibility study.

Other: Physical activity

Interventions

Physical activity OTHER

A tailored, person-centred, 12-week, chair-based exercise intervention to increase physical activity and fitness. Dose: one face-face session with a qualified physiotherapist plus two independent sessions per week. This is combined with education on self-management, self-efficacy and lifestyle change.

Also known as: Education on self-management, self-efficacy and lifestyle

Physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or over
• Clinical diagnosis of stroke
• Non-ambulatory, defined as requiring at least "continuous or intermittent support of one person to help with balance or coordination" (i.e. Functional Ambulatory Category ≤ 2) most of the time.
• Able to give informed consent (by proxy if appropriate)
• Able to travel via private taxi to community venue (for group exercise, if preferred)
• For care home residents: participant must not be participating in any structured form of PA run within their care home.
• Participant residing in private home or care home (must be discharged from in-patient care at start of intervention)

You may not qualify if:

• Judged by treating GP to be too unwell to participate
• Uncontrolled medical condition that contraindicates exercise e.g. uncontrolled cardiac condition
• Severe cognitive impairment (unable to follow and understand instructions)
• \- Able to give informed consent
• \- Not well enough to participate (as per self-report)

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• University of Edinburgh: collaborator
• Edinburgh Napier University: collaborator

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Frederike MJ van Wijck, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinding: outcomes are assessed by independent assessors, otherwise not involved in the study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants can select either individual treatment at home, or group treatment in a community setting, but the intervention content and dose are the same.

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 10, 2018
• Study Start: January 9, 2017
• Primary Completion: January 16, 2018
• Study Completion: April 30, 2018
• Last Updated: August 16, 2021

Record last verified: 2021-08