- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594527
Southampton Mobility Volunteer Programme (SoMoVe)
The Southampton Mobility Volunteer Programme to Increase Physical Activity Levels of Older Inpatients: A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Previous research has shown that low mobility among older people in hospital is associated with poor health outcomes including worsening physical function and increasing dependence in activities of daily living. There is evidence that the implementation by hospital staff of a mobility or exercise programme for older people in the acute care setting is feasible with promising outcomes including improvement in physical function, shorter hospital stay and reduced nursing home admissions. However employing additional therapy or nursing staff is costly and there are well-recognised shortages of suitable applicants to recruit to these posts. Many National Health Service trusts have an established volunteer workforce and in Southampton trained volunteers have successfully assisted older inpatients at mealtimes.
Objective: This study aims to assess the feasibility and acceptability of using trained volunteers to increase physical activity levels of older people in hospital.
Methods and design: The first part of this feasibility study is the development with the therapy team of a training programme, based on existing literature and best practice, to ensure competency of volunteers in mobilising patients and encouraging physical exercise. The study will be conducted on 2 wards (1 male 1 female) within the Medicine for Older People department. Eligible patients will be encouraged by volunteers to mobilise or perform chair-based exercises, depending on their mobility status, at least twice a day for about 15 minutes each session. The recruitment and retention rates of volunteers will be analysed as will the physical activity interventions they were able to effect. The recruitment of patients, their physical activity and adherence to the intervention will be studied. Qualitative interviews and focus groups will be conducted to explore the views and experiences of the patients, volunteers and health care professionals involved in this study. Participants will be characterised including the measurement of physical activity levels using a StepWatch Activity Monitor and GENEActiv accelerometer. This feasibility study is not powered to show a statistical difference in the outcome measures but data from this study will determine the sample size for future controlled trials.
Discussion: Results from this study will provide valuable information regarding the use of trained volunteers to promote physical activity among older inpatients and the practicalities of implementing the intervention throughout the whole department.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hampshire
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Southampton, Hampshire, United Kingdom, SO16 6YD
- University Hospital Southampton NHS Foundation Trust
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Southampton, Hampshire, United Kingdom, SO16 6YD
- Academic Geriatric Medicine, University of Southampton
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- deemed appropriate by the medical team and therapists to receive a physical activity intervention by trained volunteers and able to mobilise with or without a walking aid.
Exclusion Criteria:
- patients normally resident in a nursing home, or who were immobile prior to admission;
- patients who are in a side room for infection control reasons;
- palliative care patients;
- patients deemed inappropriate for the physical activity intervention by the medical or therapy teams.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Volunteer-led physical activity sessions
Patient will receive volunteer-led physical activity sessions twice a day during admission.
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Participants will be encouraged by volunteers to walk or perform chair-based exercises during their stay in hospital
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of using trained volunteers to promote increased physical activity among hospitalised older people
Time Frame: 2 year
|
Number of volunteers recruited
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2 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of using trained volunteers to promote increased physical activity among hospitalised older people
Time Frame: 2 years
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Established through interviews and focus groups among patients, volunteers and healthcare staff members.
|
2 years
|
StepWatch Activity Monitor
Time Frame: 2 years
|
Mean step count
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2 years
|
GENEActiv accelerometer
Time Frame: 2 years
|
Mean acceleration in milligravity
|
2 years
|
Elderly Mobility Scale
Time Frame: 2 years
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2 years
|
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Barthel Index
Time Frame: 2 years
|
2 years
|
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Timed Up and Go test
Time Frame: 2 years
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2 years
|
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Mini-mental state examination
Time Frame: 2 years
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2 years
|
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Geriatric Depression Score
Time Frame: 2 years
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2 years
|
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Gait speed
Time Frame: 2 years
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2 years
|
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Euro-Qol
Time Frame: 2 years
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Measure of quality of life
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2 years
|
Length of hospital stay
Time Frame: 2 years
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2 years
|
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Discharge destination
Time Frame: 2 years
|
2 years
|
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Incidence of thrombotic events
Time Frame: 2 years
|
2 years
|
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Incidence of pressure ulcer
Time Frame: 2 years
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2 years
|
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Short Form-36 General Health
Time Frame: 2 years
|
2 years
|
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Feasibility assessed by number of volunteers trained
Time Frame: 2 years
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2 years
|
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Feasibility study assessed by number of volunteers retained
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Lim, BM, University of Southampton
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RHM MED1297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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