Feasibility of a Physical Activity Programme for Older Adults in Nursing Homes
NCT ID: NCT03484715
Last Updated: 2018-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-05-01
2019-07-31
Brief Summary
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Detailed Description
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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?
2. Are the outcome measures feasible and acceptable to participants?
* What is the required time and number of visits required to collect each outcome from participants?
* Are the outcome measures acceptable to participants?
* What is the level of missing data within the self-reported outcome measures?
3. What is the required sample size for a definitive randomised?
* What is the baseline score and variability of the primary outcome measure among participants?
* What is the estimated effect size and variance for the primary outcome measure?
* What are the recruitment and attrition rates for nursing homes and participants? Do these rates differ between the intervention and control groups?
The secondary research questions of the pilot study are:
4. What are the preliminary clinical outcomes and cost-effectiveness of the intervention compared to the control group?
* What are the components of usual care for participants allocated to the control group?
* What are the estimated outcomes of the intervention in comparison with the control group and are these sustained at 12 month follow-up?
* What are the costs of the intervention in comparison to costs in the control group?
* What is the feasibility of collecting health economic data (i.e. sources used and time taken)?
Design:
A randomised controlled pilot feasibility study, including a qualitative and economic component will be carried out. Two randomly selected nursing homes will take part in the study; participants (n=20) in one nursing home will receive the physical activity intervention and participants (n=20) in the other will receive usual care. In order to avoid contamination between intervention and control groups, randomisation will take place at nursing home level. The pilot feasibility study will not be an exact scale model of a definitive RCT, the difference being that outcome assessment will not be blinded as a full analysis of outcome data is not intended. However, the recruitment, randomisation, assessment and intervention conditions will be similar to a definitive RCT in order to answer the feasibility research questions. Quantitative outcome data will be collected in an unblinded manner from participants at T1 (baseline, pre-intervention), T2 (directly after completion of the intervention at 4 months) to examine the immediate intervention outcomes and T3 (12 months following the start of the intervention) to examine if the outcomes are sustained beyond intervention completion.
Qualitative component:
A qualitative descriptive approach will be taken for the qualitative component of the study. Qualitative data will be collected from participants and staff of the intervention group within 1 month following intervention completion and again with the participants at 7 months following intervention completion. Data will be collected via audio-recorded semi structured one-to-one interviews. The aim of the interviews with participants will be to explore the participant's experiences of receiving the intervention, the feasibility and acceptability of the intervention, the perceived effects of the intervention, including potential adverse effect, and issues around maintenance of the participants' physical activity over time, following intervention completion. The staff interviews will explore the staffs' role and experiences of being involved in the study, including their participation in the staff education sessions and the delivery of the physical activity programmes. Semi-structured qualitative interviews will be conducted with small subset of participants from the control group on two occasions. The first interviews will take place immediately following the recruitment and consent stage of the study, in order to maximise the feasibility data obtained for these study processes. The second interviews will take place upon completion of the 4 month intervention with the objective being to define and describe usual care.
Economic component:
A preliminary estimate of the costs and outcomes of the intervention relative to the usual care control will be assessed using a cost effectiveness analysis and cost utility analysis. Resource use associated with delivery of the physical activity intervention will be measured and costed. Resources used by participants over the course of the study will be recorded in both groups, for example health service usage, medication usage and private expenses relating to the intervention. Data collected from the primary outcome measure, the Timed Up and Go test, at each time point will be used alongside resource usage to provide the basis for the cost effectiveness analysis. For the cost utility analysis, effectiveness will be evaluated on the basis of the Quality Adjusted Life Year which will be estimated using the EuroQol 5 Dimensions 5 Levels instrument, assessed at baseline, 4 month and 12 month follow-up.
Statistical analysis:
SPSS Statistics (24.0 for Windows, Chicago, USA) will be use to analyse quantitative data. Demographical information in both groups will be tabulated and summarised. The effect of the intervention on clinical outcomes will be examined using suitable numerical and graphical summaries. The statistical analysis will serve primarily to provide an estimation of likely effect size and variance of effect size rather than statistical significance. Qualitative data will be analysed using NVivo (QSR International Pty Ltd. Version 11, 2015). Interviews will be transcribed verbatim and analysed using thematic analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Physical Activity Intervention
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.
Physical Activity Intervention
A physical activity programme will be developed by the researcher for each participant. Integral to each physical activity programme will be a walking component (i.e. structured and gradual increases in daily walking time) and sit-to-stand exercises (i.e. a specified number of repeated rises from a chair). The rest of the physical activity programme will be tailored around each participant's specific functional goal and will be based on repeating particular functional activities. This programme will take place on 3 days per week in month 1, 4 days per week in month 2 and 3, and 5 days a week in month 4.
Usual Care Control
The participants in the control arm will receive usual care, which will be guided by current nursing and medical care plans.
No interventions assigned to this group
Interventions
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Physical Activity Intervention
A physical activity programme will be developed by the researcher for each participant. Integral to each physical activity programme will be a walking component (i.e. structured and gradual increases in daily walking time) and sit-to-stand exercises (i.e. a specified number of repeated rises from a chair). The rest of the physical activity programme will be tailored around each participant's specific functional goal and will be based on repeating particular functional activities. This programme will take place on 3 days per week in month 1, 4 days per week in month 2 and 3, and 5 days a week in month 4.
Eligibility Criteria
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Inclusion Criteria
* 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
* A significant sensory impairment, physical impairment or illness that impairs their ability to participate.
* Uncontrolled cardiovascular, musculoskeletal or neurological disorders.
65 Years
ALL
Yes
Sponsors
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Irish Research Council
OTHER
National University of Ireland, Galway, Ireland
OTHER
Responsible Party
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Eva Barrett
Postdoctoral Fellow
Principal Investigators
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Eva Barrett, PhD
Role: PRINCIPAL_INVESTIGATOR
National Univeristy of Ireland, Galway
Central Contacts
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References
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Hallal PC, Andersen LB, Bull FC, Guthold R, Haskell W, Ekelund U; Lancet Physical Activity Series Working Group. Global physical activity levels: surveillance progress, pitfalls, and prospects. Lancet. 2012 Jul 21;380(9838):247-57. doi: 10.1016/S0140-6736(12)60646-1.
Crocker T, Forster A, Young J, Brown L, Ozer S, Smith J, Green J, Hardy J, Burns E, Glidewell E, Greenwood DC. Physical rehabilitation for older people in long-term care. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD004294. doi: 10.1002/14651858.CD004294.pub3.
Peri K, Kerse N, Robinson E, Parsons M, Parsons J, Latham N. Does functionally based activity make a difference to health status and mobility? A randomised controlled trial in residential care facilities (The Promoting Independent Living Study; PILS). Age Ageing. 2008 Jan;37(1):57-63. doi: 10.1093/ageing/afm135. Epub 2007 Oct 25.
Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64. doi: 10.1177/1090198104263660.
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 3(2): 77-101, 2006.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Holthe T, Thorsen K, Josephsson S. Occupational patterns of people with dementia in residential care: an ethnographic study. Scand J Occup Ther. 2007 Jun;14(2):96-107. doi: 10.1080/11038120600963796.
Barrett E, Gillespie P, Newell J, Casey D. Feasibility of a physical activity programme embedded into the daily lives of older adults living in nursing homes: protocol for a randomised controlled pilot feasibility study. Trials. 2018 Aug 29;19(1):461. doi: 10.1186/s13063-018-2848-4.
Other Identifiers
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GOIPD/2017/1301
Identifier Type: -
Identifier Source: org_study_id
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