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临床试验/NCT03492957
NCT03492957已完成不适用

PHysical Activity for Non-ambulatory Stroke Survivors (PHANSS-2): Developing a Feasible and Acceptable Intervention for Stroke Survivors Who Cannot Walk Independently

Glasgow Caledonian University0 个研究点目标入组 9 人开始时间: 2017年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
主要终点
Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

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).

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Blinding: outcomes are assessed by independent assessors, otherwise not involved in the study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •(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)

排除标准

  • •(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)

研究组 & 干预措施

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.

干预措施: Physical activity (Other)

结局指标

主要结局

Canadian Occupational Performance Measure (COPM)

时间窗: 3-month follow-up

Person-centred tool for goal setting and evaluation

次要结局

  • Stroke Self-Efficacy questionnaire (SSEQ)(3-month follow-up)
  • Hospital Anxiety and Depression Scale (HADS)(3-month follow-up)
  • Force measurements(3-month follow-up)
  • Barthel Index (BI)(3-month follow-up)
  • Stroke Impact Scale (SIS)(3-month follow-up)
  • Motricity Index (MI)(3-month follow-up)
  • Caregiver Burden Scale (CBS)(3-month follow-up)
  • Activity data(3-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

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