The effectiveness and cost-effectiveness of a peer-volunteering active ageing programme in preventing mobility decline in older adults
| ISRCTN | ISRCTN17660493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17660493 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 290332 |
| Protocol serial number | CPMS 49549, IRAS 290332 |
| Sponsor | University of Birmingham |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR130156 |
- Submission date
- 02/09/2021
- Registration date
- 30/09/2021
- Last edited
- 28/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Physical inactivity is one of the strongest predictors of physical disability in older adults. An older person who remains fit and active is more likely to retain physical and cognitive function, prevent disease and disability, and enjoy independence, mental well-being and a higher quality of life. A key to successful ageing is to find effective ways of helping older people to maintain greater levels of physical activity to break the downward spiral into disability that is increasingly characteristic of old age. This in turn would provide considerable benefit in terms of human welfare and savings in social and health care cost.
Active ageing programmes help older people who are at risk of such decline to improve or maintain their mobility through physical activity. However, nationally and locally resources to support such programmes are scarce. The voluntary sector is ideally placed to mobilise older adults to act as volunteers to deliver these programmes. Unfortunately, little evidence exists as to whether volunteer-driven, community-based active ageing programmes actually work and are cost-effective. This is what this study is designed to test.
Who can participate?
ACE is a low-cost programme where up to 150 older volunteers (aged 55 years +) will support older people (65 years +) to improve their mobility by becoming more active within their communities. The 515 older people recruited to the study will be sedentary and community living, with functional limitations (i.e. who are at risk of major mobility limitations), but who can still walk independently (including walking with a walking stick). This will be measured using a physical function test to assess balance, walking speed and the ability to go from a sitting to a standing position. The researchers are targeting a non-disabled but at-risk population. Participants will mainly be recruited via invitations sent by GPs to patients who meet the inclusion criteria. A small-scale feasibility study conducted several years ago confirmed that ACE was well-received by both participants and volunteers and appeared to deliver a positive impact on the physical and mental well-being of both groups.
What does the study involve?
During the ACE programme, volunteers will meet with participants twice to get to know each other, find out about and discuss local community-based activities that the participant would like to join, and identify and address any barriers to taking part (weeks 1 and 2). Then, over a 3-month period, the volunteer-participant pair will attend at least three local activities chosen by the participant, together. Over the following 3 months volunteers will support the participant to continue attending these activities independently through regular phone calls, with further joint visits to activities scheduled if needed. Volunteers will attend a two-day ACE training course prior to taking part.
Participants will be randomly assigned to either the ACE programme or a comparison group who will receive information about healthy ageing, attend two social events including a health ageing presentation. but will not be paired with a volunteer. All participants and volunteers will complete a set of measures at the start of the study and then 6 and 18 months later. These measurements will include tests of mobility (a balance test, a ‘sit-to-stand’ test and a walking speed test), physical activity and questionnaires to measure mental wellbeing, quality of life and how much people use health and social care services. The results from those taking part in the ACE programme and those in the comparison group will be compared so the researchers can assess whether the programme is effective and cost-effective.
What are the possible benefits and risks of participating?
Getting out and about more has been shown to increase levels of physical activity in older adults. A recent UK Chief Medical Officer’s report said that “engaging in physical activity carries very low health and safety risks for most older adults. In contrast, the risks of poor health as a result of inactivity are very high”. ACE is designed to help people who take part to gradually become more active. Government safety guidelines in relation to COVID-19 will be followed at all times for any face-to-face meetings.
People in the intervention group will get out and about more, with a volunteer for support and encouragement. This will help people to become more active, which could help improve their ability to perform daily activities, increase strength and stamina and help maintain the physical function needed to continue living independently. It also means they will have the chance to socialise with other people. Older adults often find being involved in research a positive experience, finding it interesting and stimulating. Participants will also be contributing to a large pioneering study that will provide very important information for the NHS and, if successful, may improve the health of many other older adults in the future.
Where is the study run from?
The Universities of Birmingham and Manchester and Cardiff Metropolitan University (UK)
When is the study starting and how long is it expected to run for?
February 2019 to May 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Prof. Afroditi Stathi, a.stathi@bham.ac.uk
2. Dr Janet Withall, j.withall@bham.ac.uk
Contact information
Scientific
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0003-2162-777X |
|---|---|
| Phone | +44 (0)121 415 8589 |
| a.stathi@bham.ac.uk |
Scientific
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| ORCID ID |
0000-0003-0196-5309 |
|---|---|
| Phone | +44 (0)121 415 8589 |
| j.withall@bham.ac.uk |
Scientific
Cardiff Metropolitan University
Cardiff
CF23 6XD
United Kingdom
| ORCID ID |
0000-0002-8798-2929 |
|---|---|
| Phone | +44 (0)29 2041 7092 |
| dmcrone@cardiffmet.ac.uk |
Scientific
University of Manchester
Manchester
M19 3PL
United Kingdom
| ORCID ID |
0000-0002-2451-4482 |
|---|---|
| Phone | +44 (0)161 306 7863 |
| helen.hawley-hague@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Both; Design type: Prevention, Psychological & Behavioural, Complex Intervention, Physical, Health Economic |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 40359_PIS_V1.1_21Jun21.pdf |
| Scientific title | A multi-centre randomised controlled trial of a peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability: the ACE (Active, Connected, Engaged) study |
| Study acronym | ACE |
| Study objectives | Compared with an information-only control group, participants allocated to the ACE programme will have significantly reduced mobility-related limitations, as indicated by SPPB score, at 18 months of follow-up. |
| Ethics approval(s) | Approved 11/08/2021, London - Surrey Research Ethics Committee (Nottingham Centre, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)2071048276; surrey.rec@hra.nhs.uk), REC ref: 21/LO/0433 |
| Health condition(s) or problem(s) studied | Physical function in older people at risk of mobility disability |
| Intervention | The ACE study is an individually randomised, parallel-group, single-blind randomised controlled trial with an internal pilot phase, a whole-systems oriented process evaluation and an economic evaluation. Participants, who will be 65 years old or older, will mainly be recruited via a letter of invitation from their GPs. 515 patients who meet the study inclusion criteria will be randomised to receive either the ACE intervention, delivered over a period of 6 months by peer volunteers, or a minimal control intervention. Peer volunteers will be recruited and managed by volunteering organisations such as the Royal Volunteering Service. ACE is a low-cost programme where older volunteers (55 years +) support older people (65 years +) to improve their mobility by becoming more active within their communities. The 515 older people recruited to the study will be sedentary and community living, with functional limitations (i.e. who are at risk of major mobility limitations), but who can still walk independently (including with a walking stick). This will be measured using a physical function test to assess balance, walking speed and the ability to go from a sitting to a standing position. The researchers are targeting a non-disabled, but at-risk population. During the ACE programme, volunteers (n=150) will meet with participants twice to get to know each other, find out about and discuss local community-based activities that the participant would like to join, and identify and address any barriers to taking part (weeks 1 and 2). Then, over a 3-month period, the volunteer-participant pair will attend at least three local activities chosen by the participant, together. Over the following 3 months volunteers will support the participant to continue attending these activities independently through regular phone calls, with further joint visits to activities scheduled if needed. Volunteers will attend an ACE training course prior to taking part. Participants will be randomly assigned to either the ACE programme or a comparison group in a 1:1 ratio stratified by site using a centralised web-based system run by the Cardiff Centre for Trials Research (CTR). The comparison group will receive information about healthy ageing and will be invited to two social events which will include a health ageing presentation, but will not be paired with a volunteer. The researchers will run an internal pilot study with 90 participants to test our recruitment procedures and to allow (if needed) fine-tuning of our recruitment and the intervention. They will make the decision whether to go ahead with the full trial based on the success of this pilot. All participants and volunteers will complete a set of measures at the start of the study and then again 6 and 18 months later. These measurements will include tests of mobility (a balance test, a ‘sit-to-stand’ test and a walking speed test), physical activity and questionnaires to measure mental wellbeing, quality of life and how much people use health and social care services. The results from those taking part in the ACE programme and those in the comparison group will be compared to assess whether the programme is effective and cost effective. The researchers will also telephone participants and volunteers at 12 months and ask them to answer some of the questions from the 6 and 18-month questionnaire over the phone. Some participants in the intervention group and some volunteers will be interviewed or attend a focus group to provide feedback on ACE. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Lower limb physical function assessed using a Short Physical Performance Battery (SPPB) at baseline, 6 and 18 months |
| Key secondary outcome measure(s) |
Participants and volunteers: |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 515 |
| Total final enrolment | 528 |
| Key inclusion criteria | 1. Short Physical Performance Battery (SPPB) score between 4 and 9 inclusive. This is based on definitions of physical frailty from the European Medicines Agency for identifying people with (or at risk of) physical frailty in clinical trials. This guidance defines pre-frailty as an SPPB score of 8-9 and frailty as an SPPB score of 7 or less 2. Planning to reside in the target area for intervention delivery for at least 18 months |
| Key exclusion criteria | 1. Self-reported inability to walk across a room without help (use of a stick for support is acceptable) 2. Being too physically active (defined by four verbal screening questions (How would you find walking across a room? How easy would you find getting out of a low chair? How easy would you find walking up a flight of stairs with no handrail or wall to lean on? How easy do you find walking on uneven pavement without losing your balance? Responses easy/a little difficult/very difficult) 3. Having an existing major mobility limitation (SPPB of 3 or less) 4. Living in residential or nursing care; e) Having any serious medical conditions that would preclude participation |
| Date of first enrolment | 01/11/2021 |
| Date of final enrolment | 28/02/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
Edgbaston
Birmingham
B15 2TT
United Kingdom
Manchester
M13 9PL
United Kingdom
Cyncoed Road
Cardiff
CF23 6XZ
United Kingdom
Cardiff
CF23 8RP
United Kingdom
Bath
BA2 7AY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Afroditi Stathi (A. Stathi@bham.ac.uk). The de-identified data will become available after the publication of the core publications and the NIHR Library report related to the grant, and they will be available for 5 years. Consent from participants for use of data for future research has been obtained. The researchers do not forsee any ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 29/11/2023 | 01/12/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | 13/06/2024 | 28/02/2025 | Yes | No | |
| Participant information sheet | version 1.1 | 21/06/2021 | 24/09/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 5 | 22/07/2022 | 03/08/2023 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 40359_PIS_V1.1_21Jun21.pdf
- Participant information sheet
- ISRCTN17660493_Protocol_V5_22Jul2022.pdf
- Protocol file
Editorial Notes
28/02/2025: Publication reference added.
03/02/2025: The following changes were made to the trial record:
1. The overall end date was changed from 31/05/2025 to 31/12/2025.
2. The recruitment end date was changed from 30/11/2023 to 28/02/2024.
3. The study participating centre University of Bath was added.
4. The total final enrolment was added.
01/12/2023: Publication reference added.
03/08/2023: Protocol file uploaded.
06/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2023 to 30/11/2023.
2. The overall trial end date was changed from 31/08/2024 to 31/05/2025.
3. IPD sharing statement added.
18/10/2021: Internal review.
01/10/2021: Internal review.
02/09/2021: Trial's existence confirmed by the NIHR.
