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临床试验/NCT03484715
NCT03484715Unknown不适用

Feasibility of a Physical Activity Programme Embedded Into the Daily Lives of Older Adults Living in Nursing Homes: a Randomised Controlled Pilot Feasibility Study

National University of Ireland, Galway, Ireland0 个研究点目标入组 40 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Proportion of eligible nursing homes which agree to participate in study

研究概览

简要总结

Older people living in nursing homes spend the majority of their time inactive. The current study has designed a physical activity intervention for older people living in nursing homes whereby the participants will incorporate more physical activity throughout their daily activities. Each participant's physical activity programme will be tailored to their physical abilities and to a pre-defined goal. The aim of this pilot feasibility study is to explore the feasibility and acceptability of this physical activity programme and to examine the preliminary effects of this on physical mobility and health-related quality of life, when compared to a usual care control group.

详细描述

Physical inactivity is a global health pandemic and is one of four leading contributors to premature mortality. Although there is evidence that physical activity improves short-term function and is safe among older adults of long-term care, the optimum contents of a physical activity programme or how best to implement it remain unclear. Few studies in nursing homes have attempted to increase physical activity levels by incorporating more usual activities into the resident's everyday routine. The proposed pilot feasibility study will implement a person-centred physical activity programme into the participant's daily routine, based on increasing duration and repetitions of everyday functions including walking and rising from a chair. It incorporates key constructs of social cognitive theory and is monitored by nursing home staff who will receive training and support.

Research questions:

This pilot feasibility study will have the following primary research questions:

  1. Is the intervention feasible and acceptable to staff and participants?
  • Is the time commitment required for staff to monitor the intervention and participants to partake in the intervention feasible?
  • Are there any environmental barriers to completion of the intervention?
  • Is the content of the intervention acceptable to participants and staff?
  • Do the participants adhere to the intervention and what adherence issues arise?
  1. Are the outcome measures feasible and acceptable to participants?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

As the primary aim of this study is to establish feasibility of the intervention and study processes, there will be no outcome assessor or participant blinding.

入排标准

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

入选标准

  • Aged 65 or over.
  • Can speak and understand English.
  • Resident in nursing home for at least 3 months.
  • Able to rise from a chair with armrests (with or without a walking aid) and able to walk at least 10 metres (with or without a walking aid) independently or with minimal assistance.
  • Approval of the resident's General Practitioner to participate.
  • Cognitively capable of providing informed consent to participate, as judged by the key nurse caring for the participant.
  • Cognitive function of a score of greater than 20 on the Mini Mental State Examination.

排除标准

  • Admission to nursing home for respite or end-stage terminal care.
  • A significant sensory impairment, physical impairment or illness that impairs their ability to participate.
  • Uncontrolled cardiovascular, musculoskeletal or neurological disorders.

研究组 & 干预措施

Physical Activity Intervention

Experimental

Each participant in this arm will outline a small number of activity-related goals and will receive a 4 month personalised physical programme where additional physical activity will be incorporated into their daily routines. Nursing home staff will receive two educational sessions, which will provide them with the necessary skills to monitor participants physical activity programmes within the nursing home.

干预措施: Physical Activity Intervention (Behavioral)

Usual Care Control

No Intervention

The participants in the control arm will receive usual care, which will be guided by current nursing and medical care plans.

结局指标

主要结局

Proportion of eligible nursing homes which agree to participate in study

时间窗: Up to 2 months

This will be expressed as a percentage of nursing homes which agree to participate in study out of the nursing homes which were invited to participle in study.

Proportion of eligible nursing home residents which agree to participate in study

时间窗: Up to 1 month

This will be expressed as a percentage of participants which agree to participate in study out of the participants which were invited to participle in study.

Time for recruitment of nursing homes

时间窗: Up to 2 months

This is be defined as time from initial contact with first nursing home to signing of final nursing home participation form and will be expressed as number weeks and days.

Time for recruitment of participants within nursing homes

时间窗: Up to 1 month

This is be defined as time from initial contact with first participant to signing of final participant consent form and will be expressed as number of weeks and days.

Retention rate of nursing homes at 4 month follow-up.

时间窗: Assessed at 4 month follow-up.

This is defined as percentage of nursing homes remaining in study at 4 month follow-up.

Retention rate of nursing homes at 12 month follow-up

时间窗: Assessed at 12 month follow-up.

This is defined as percentage of nursing homes remaining in the study at 12 month follow-up.

Retention rate of participants at 4 months

时间窗: Assessed at 4 month follow-up

This is defined as percentage of participants remaining in study at 4 month follow-up.

Retention rate of participants at 12 month follow-up

时间窗: Assessed at 12 month follow-up.

This is defined as percentage of participants remaining in the study at 12 month follow-up.

Adherence rate of participants to the intervention

时间窗: Assessed at 4 month follow-up

This will provide feasibility data. This will be expressed as the percentage of participants completing 75% of their physical activity programme according to the participant adherence sheets.

次要结局

  • Bangor Goal Setting Interview(This will be assessed at baseline, directly after completion of the intervention at 4 months and at 12 months after the start of the intervention)
  • Timed Up and Go Test(This will be assessed at baseline, directly after completion of the intervention at 4 months and at 12 months after the start of the intervention.)
  • Nottingham Health Profile(This will be assessed at baseline, directly after completion of the intervention at 4 months and at 12 months after the start of the intervention)
  • 10 Metre Walk Test(This will be assessed at baseline, directly after completion of the intervention at 4 months and at 12 months after the start of the intervention)
  • ICEpop CAPability measure for Older people (ICECAP-O)(This will be assessed at baseline, directly after completion of the intervention at 4 months and at 12 months after the start of the intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Barrett

Postdoctoral Fellow

National University of Ireland, Galway, Ireland

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