Old Age Clinical Trial
Official title:
Feasibility of a Physical Activity Programme Embedded Into the Daily Lives of Older Adults Living in Nursing Homes: a Randomised Controlled Pilot Feasibility Study
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | July 31, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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National University of Ireland, Galway, Ireland | Irish Research Council |
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of eligible nursing homes which agree to participate in study | 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. | Up to 2 months | |
Primary | Proportion of eligible nursing home residents which agree to participate in study | 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. | Up to 1 month | |
Primary | Time for recruitment of nursing homes | 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. | Up to 2 months | |
Primary | Time for recruitment of participants within nursing homes | 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. | Up to 1 month | |
Primary | Retention rate of nursing homes at 4 month follow-up. | This is defined as percentage of nursing homes remaining in study at 4 month follow-up. | Assessed at 4 month follow-up. | |
Primary | Retention rate of nursing homes at 12 month follow-up | This is defined as percentage of nursing homes remaining in the study at 12 month follow-up. | Assessed at 12 month follow-up. | |
Primary | Retention rate of participants at 4 months | This is defined as percentage of participants remaining in study at 4 month follow-up. | Assessed at 4 month follow-up | |
Primary | Retention rate of participants at 12 month follow-up | This is defined as percentage of participants remaining in the study at 12 month follow-up. | Assessed at 12 month follow-up. | |
Primary | Adherence rate of participants to the intervention | 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. | Assessed at 4 month follow-up | |
Secondary | Timed Up and Go Test | This is a test of physical mobility and measures the time taken by an individual to stand up from a standard arm chair, walk a distance of 3 metres at a comfortable pace, turn, walk back to the chair, and sit down. Change in Timed Up and Go score will be measured in seconds. | 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. | |
Secondary | Nottingham Health Profile | This provides a measure of health-related quality of life and change in Nottingham Health Profile score will be evaluated. The questionnaire measures self-perceived health across six domains: (i) sleep (ii) mobility (iii) energy (iv) pain (v) emotional reactions (vi) social isolation. Scores range from 0 to 1, with 0 indicating poor health and 1 indicating good health. There are no subscale scores to be reported. | 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 | |
Secondary | 10 Metre Walk Test | This is a measure of gait speed and the change in gait speed will be reported in seconds. The participant will walk 10 metres and the time is measured for the intermediate 6 metres to allow for acceleration and deceleration. The timer is started when the toes of the leading foot cross the 2-metre mark and stopped when the toes of the leading foot cross the 8-metre mark. | 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 | |
Secondary | ICEpop CAPability measure for Older people (ICECAP-O) | This provides a measure of capability-related quality of life and change in ICECAP-O score will be evaluated. The scale of this score ranges from 0 to 1, with 0 representing no capability and 1 representing full capability. There are no subscale scores to be reported. | 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. | |
Secondary | Bangor Goal Setting Interview | In the intervention group only, the participant will rate their current performance and satisfaction with performance for their activity-based goal on a 1-10 Likert scale (where 1 means cannot do or am not doing successfully and 10 means can do and am doing very successfully). Change in scores will be evaluated. | 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 |
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