Physical ActivitySoMoVeNCT02594527
Southampton Mobility Volunteer Programme
A study testing Volunteer-led physical activity session in people with Physical Activity, run by University of Southampton at 2 sites in United Kingdom.
Trial summary
Physical activity levels of hospitalised older inpatients is low and this results in many adverse health outcomes. Studies have shown that interventions designed to promote increased physical activity of older inpatients using paid staff have shown improvement in physical function of older inpatients, resulting in… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Volunteer-led physical activity session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Academic Geriatric Medicine, University of Southampton
Southampton, Hampshire, SO16 6YD
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: The Southampton Mobility Volunteer Programme to Increase Physical Activity Levels of Older Inpatients: A Feasibility Study
Physical activity levels of hospitalised older inpatients is low and this results in many adverse health outcomes. Studies have shown that interventions designed to promote increased physical activity of older inpatients using paid staff have shown improvement in physical function of older inpatients, resulting in shorter hospital stay and reduced admissions to nursing home. This study aims to assess the feasibility and acceptability of using trained volunteers to increase physical activity of older people in hospital. Volunteers will be recruited and trained to encourage older inpatients to mobilise or perform chair-based exercises. Patients will be encouraged to walk or exercise with the volunteers twice a day during their hospital stay. Quantitative analysis will be conducted on the outcome measures. Patients, volunteers and staff members will also be interviewed to assess the acceptability of the intervention. This feasibility study will help inform a future controlled trial.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Volunteer-led physical activity session
- Keywords
- Older people, Physical activity, Hospital
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volunteer-led physical activity sessionOther
Participants will be encouraged by volunteers to walk or perform chair-based exercises during their stay in hospital
| Study group | Role | What they receive |
|---|---|---|
| Volunteer-led physical activity sessions | Experimental | Patient will receive volunteer-led physical activity sessions twice a day during admission. Receives: Other: Volunteer-led physical activity session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using trained volunteers to promote increased physical activity among hospitalised older people
Number of volunteers recruited
Measured: 2 year
Secondary outcomes (17)
Acceptability of using trained volunteers to promote increased physical activity among hospitalised older people
Established through interviews and focus groups among patients, volunteers and healthcare staff members.
Measured: 2 years
StepWatch Activity Monitor
Mean step count
Measured: 2 years
GENEActiv accelerometer
Mean acceleration in milligravity
Measured: 2 years
Elderly Mobility Scale
Measured: 2 years
Barthel Index
Measured: 2 years
Timed Up and Go test
Measured: 2 years
Mini-mental state examination
Measured: 2 years
Geriatric Depression Score
Measured: 2 years
Gait speed
Measured: 2 years
Euro-Qol
Measure of quality of life
Measured: 2 years
Length of hospital stay
Measured: 2 years
Discharge destination
Measured: 2 years
Incidence of thrombotic events
Measured: 2 years
Incidence of pressure ulcer
Measured: 2 years
Short Form-36 General Health
Measured: 2 years
Feasibility assessed by number of volunteers trained
Measured: 2 years
Feasibility study assessed by number of volunteers retained
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Stephen Lim, BM, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594527
- Sponsor's protocol ID
- RHM MED1297
- Acronym
- SoMoVe
- Status last verified
- May 2021
- First submitted
- 19 Oct 2015
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lim S, Ibrahim K, Dodds R, Purkis A, Baxter M, Rogers A, Sayer AA, Roberts HC. Physical activity in hospitalised older people: the feasibility and acceptability of a volunteer-led mobility intervention in the SoMoVe study. Age Ageing. 2020 Feb 27;49(2):283-291. doi: 10.1093/ageing/afz114.
PubMed 31566671
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Southampton Mobility Volunteer Programme to Increase Physical Activity Levels of Older Inpatients: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02594527
- Acronym / sponsor ID
- SoMoVe / RHM MED1297
- Conditions
- Physical Activity
- Keywords
- Older people, Physical activity, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity levels of hospitalised older inpatients is low and this results in many adverse health outcomes. Studies have shown that interventions designed to promote increased physical activity of older inpatients using paid staff have shown improvement in physical function of older inpatients, resulting in shorter hospital stay and reduced admissions to nursing home. This study aims to assess the feasibility and acceptability of using trained volunteers to increase physical activity of older people in hospital. Volunteers will be recruited and trained to encourage older inpatients to mobilise or perform chair-based exercises. Patients will be encouraged to walk or exercise with the volunteers twice a day during their hospital stay. Quantitative analysis will be conducted on the outcome measures. Patients, volunteers and staff members will also be interviewed to assess the acceptability of the intervention. This feasibility study will help inform a future controlled trial.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteer-led physical activity sessions | Experimental | Other: Volunteer-led physical activity sessionPatient will receive volunteer-led physical activity sessions twice a day during admission. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volunteer-led physical activity sessionParticipants will be encouraged by volunteers to walk or perform chair-based exercises during their stay in hospital | Other | Volunteer-led physical activity sessions |
Primary outcome
Feasibility of using trained volunteers to promote increased physical activity among hospitalised older people
Time frame: 2 year
Number of volunteers recruited
17 secondary outcomes
Acceptability of using trained volunteers to promote increased physical activity among hospitalised older people
Time frame: 2 years
StepWatch Activity Monitor
Time frame: 2 years
GENEActiv accelerometer
Time frame: 2 years
Elderly Mobility Scale
Time frame: 2 years
Barthel Index
Time frame: 2 years
Timed Up and Go test
Time frame: 2 years
Mini-mental state examination
Time frame: 2 years
Geriatric Depression Score
Time frame: 2 years
Gait speed
Time frame: 2 years
Euro-Qol
Time frame: 2 years
Length of hospital stay
Time frame: 2 years
Discharge destination
Time frame: 2 years
Incidence of thrombotic events
Time frame: 2 years
Incidence of pressure ulcer
Time frame: 2 years
Short Form-36 General Health
Time frame: 2 years
Feasibility assessed by number of volunteers trained
Time frame: 2 years
Feasibility study assessed by number of volunteers retained
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Results publication: PubMed 31566671Lim S, Ibrahim K, Dodds R, Purkis A, Baxter M, Rogers A, Sayer AA, Roberts HC. Physical activity in hospitalised older people: the feasibility and acceptability of a volunteer-led mobility intervention in the SoMoVe study. Age Ageing. 2020 Feb 27;49(2):283-291. doi: 10.1093/ageing/afz114.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Lim, BM principal investigator
University of Southampton
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer-led physical activity session in people with Physical Activity, run by University of Southampton at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using trained volunteers to promote increased physical activity among hospitalised older people (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.