NCT03484715

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

March 6, 2018

Last Update Submit

March 25, 2018

Conditions

Keywords

Physical ActivityNursing HomeFeasibilityOlder Adults

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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.

  • 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

  • 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.

  • 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 Outcomes (5)

  • 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.

  • 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

Study Arms (2)

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.

Behavioral: Physical Activity Intervention

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.

Interventions

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.

Physical Activity Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 22818937BACKGROUND
  • 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.

    PMID: 23450551BACKGROUND
  • 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.

    PMID: 17965045BACKGROUND
  • Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64. doi: 10.1177/1090198104263660.

    PMID: 15090118BACKGROUND
  • Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 3(2): 77-101, 2006.

    BACKGROUND
  • 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.

    PMID: 21479777BACKGROUND
  • 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.

    PMID: 1991946BACKGROUND
  • 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.

    PMID: 17538854BACKGROUND
  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Eva Barrett, PhD

    National Univeristy of Ireland, Galway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised controlled pilot feasibility study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

March 6, 2018

First Posted

April 2, 2018

Study Start

May 1, 2018

Primary Completion

June 30, 2019

Study Completion

July 31, 2019

Last Updated

April 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share