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PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study (PHANSS)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Glasgow Caledonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring physical activity, exercise, non-ambulatory, feasibility, mixed methods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (stroke survivors):

  • 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)

Exclusion Criteria (stroke survivors):

  • 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)

Inclusion criteria (carers):

- Able to give informed consent

Exclusion criteria (carers):

- Not well enough to participate (as per self-report)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Physical activity

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Canadian Occupational Performance Measure (COPM)
    Person-centred tool for goal setting and evaluation

    Secondary Outcome Measures

    Barthel Index (BI)
    Measure to evaluate independence in activities of daily living
    Stroke Impact Scale (SIS)
    Measure to evaluate impact of intervention on stroke-related impairments, activity limitations and participation restrictions
    Stroke Self-Efficacy questionnaire (SSEQ)
    Measure to evaluate level of confidence
    Hospital Anxiety and Depression Scale (HADS)
    Measure to evaluate levels of anxiety and depression
    Motricity Index (MI)
    Clinical evaluation of muscle strength in both affected and non-affected upper and lower limbs
    Force measurements
    Quantitative measurements of muscle force in quadriceps and hamstring muscles in both affected and unaffected lower limbs using dynamometry
    Caregiver Burden Scale (CBS)
    A questionnaire to evaluate carer burden
    Activity data
    Quantitative data from an activity monitor to measure sedentary behaviour

    Full Information

    First Posted
    March 27, 2018
    Last Updated
    August 13, 2021
    Sponsor
    Glasgow Caledonian University
    Collaborators
    University of Edinburgh, Edinburgh Napier University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03492957
    Brief Title
    PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study
    Acronym
    PHANSS
    Official Title
    PHysical Activity for Non-ambulatory Stroke Survivors (PHANSS-2): Developing a Feasible and Acceptable Intervention for Stroke Survivors Who Cannot Walk Independently
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 9, 2017 (Actual)
    Primary Completion Date
    January 16, 2018 (Actual)
    Study Completion Date
    April 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Glasgow Caledonian University
    Collaborators
    University of Edinburgh, Edinburgh Napier University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    Detailed Description
    Background: Physical activity interventions after stroke are needed because stroke survivors are under-active; their average physical fitness level is about 50% of sedentary healthy controls. This adversely affects vascular risk factor profiles, disability and participation, problems that are all likely to be exacerbated in stroke survivors who are unable to walk. Fitness can be improved after stroke through cardiorespiratory training. This also improves psychosocial functioning and adaptation to life after stroke. Community-based services for exercise after stroke are developing throughout the UK. However, current evidence, associated guidelines and exercise professional training mainly pertain to ambulatory stroke survivors; non-ambulatory stroke survivors have hardly been involved in this area of research. In this study, we define "non-ambulatory" as requiring at least "continuous or intermittent support of one person to help with balance or coordination" (i.e. Functional Ambulatory Category ≤ 2). Study aim: 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). Study design: Mixed-methods, observational feasibility study. This study will incorporate qualitative interviews/focus groups to explore the experiences of the programme participants are taking part in and their thoughts and views of PA after stroke. Interviews and focus groups will be conducted throughout the physical activity programme. Participant recruitment: Participants will be recruited by the Scottish Stroke Research Network (SRN) via: databases and electronic patient medical/nursing/AHP notes, records of discharges from acute stroke wards to off-site rehabilitation units and word of mouth among AHPs., within NHS Lanarkshire. Participants will also be recruited via non-NHS sites: local community stroke groups, social media, stroke charities, press releases and related media and care homes. Study setting: Glasgow Caledonian University will be used for the community-based group programme and focus groups/interviews. Participants' own home setting will be used for the home-based, individual programme and interviews. Study participants: Non-ambulatory stroke survivors and their carers (where applicable) living at home or in care homes. Study outcomes: Outcomes will include measures of disability, ADL, strength, anxiety and depression, sedentary behaviour, self-efficacy, health status, attainment of individual goals, as well as carer burden (where appropriate). Feasibility will be assessed by numbers of participants invited to participate, accepting and being recruited into the study, completing the intervention, programme adherence and drop outs. Safety data will be examined using data on adverse effects reported by participants. Study duration: 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    physical activity, exercise, non-ambulatory, feasibility, mixed methods

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Participants can select either individual treatment at home, or group treatment in a community setting, but the intervention content and dose are the same.
    Masking
    None (Open Label)
    Masking Description
    Blinding: outcomes are assessed by independent assessors, otherwise not involved in the study.
    Allocation
    N/A
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical activity
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Physical activity
    Other Intervention Name(s)
    Education on self-management, self-efficacy and lifestyle
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Canadian Occupational Performance Measure (COPM)
    Description
    Person-centred tool for goal setting and evaluation
    Time Frame
    3-month follow-up
    Secondary Outcome Measure Information:
    Title
    Barthel Index (BI)
    Description
    Measure to evaluate independence in activities of daily living
    Time Frame
    3-month follow-up
    Title
    Stroke Impact Scale (SIS)
    Description
    Measure to evaluate impact of intervention on stroke-related impairments, activity limitations and participation restrictions
    Time Frame
    3-month follow-up
    Title
    Stroke Self-Efficacy questionnaire (SSEQ)
    Description
    Measure to evaluate level of confidence
    Time Frame
    3-month follow-up
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Description
    Measure to evaluate levels of anxiety and depression
    Time Frame
    3-month follow-up
    Title
    Motricity Index (MI)
    Description
    Clinical evaluation of muscle strength in both affected and non-affected upper and lower limbs
    Time Frame
    3-month follow-up
    Title
    Force measurements
    Description
    Quantitative measurements of muscle force in quadriceps and hamstring muscles in both affected and unaffected lower limbs using dynamometry
    Time Frame
    3-month follow-up
    Title
    Caregiver Burden Scale (CBS)
    Description
    A questionnaire to evaluate carer burden
    Time Frame
    3-month follow-up
    Title
    Activity data
    Description
    Quantitative data from an activity monitor to measure sedentary behaviour
    Time Frame
    3-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria (stroke survivors): 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) Exclusion Criteria (stroke survivors): 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) Inclusion criteria (carers): - Able to give informed consent Exclusion criteria (carers): - Not well enough to participate (as per self-report)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frederike MJ van Wijck, PhD
    Organizational Affiliation
    Glasgow Caledonian University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study

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