An evaluation of the effects of a digital web-based intervention on the physical activity of people with a musculoskeletal condition
| ISRCTN | ISRCTN14174108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14174108 |
| Secondary identifying numbers | SSPR-028 |
- Submission date
- 26/05/2021
- Registration date
- 29/07/2021
- Last edited
- 26/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Musculoskeletal conditions affect the joints, bones and muscles. The aim of this study is to understand physical activity in people with a musculoskeletal condition, and the impact of a 12-week online physical activity programme on physical activity levels and quality of life. This study will allow for a greater understanding of the needs of people living with a musculoskeletal condition, in regards to physical activity, and how online physical activity programmes can be better designed, developed, and distributed in the future.
Who can participate?
People with a musculoskeletal condition, aged over 18 years, with the ability to read and write English and provide informed consent; who are not participating in 150 minutes (2.5 hours) or more of physical activity in a normal week. Participants should be willing to complete regular emailed surveys.
What does the study involve?
Participants will receive, over email, access to an online physical activity programme. This will either be sent straight away or three months after the start of the study – this will be decided randomly; this allows the researchers to understand the influence of the programme on physical activity (comparing those that did and did not receive access). Regardless of when participants receive access, they will be required to complete an online survey at the start of the research, once a week for 13 weeks, with a final survey at 6 months. Each online survey should take no more than 10 minutes to complete. The weekly surveys will ask participants to record their daily step count for the previous week, and their highest step count on any one day in the previous week, taken from their smartphone (if they have one) using the Pedometer α - Step Counter’ app; guidance on how to do this will be provided to all participants. Participants can still take part in this study even if they do not have a smartphone.
What are the possible benefits and risks of participation?
This study will support a greater understanding of the needs of people living with a musculoskeletal condition in regards to physical activity, and how services and information can be better designed, developed, and distributed in the future. Participants will receive an electronic copy of the final report.
The researchers do not anticipate any risks from taking part in the study. Participants will receive details of an online physical activity programme; what they do with this information and any actions that they take (or not) based on this information is up to them. Engagement with any activities mentioned within the programme is at the participant's discretion; no expectation is placed on the participant. Participants will be sent all of the information online, so no travel is required.
Where is the study run from?
London Metropolitan University (UK) - this study takes place online.
When is the study starting and how long is it expected to run for?
November 2020 to September 2022
Who is funding the study?
Versus Arthritis (UK)
Who is the main contact?
Dr Justin Webb
j.webb1@londonmet.ac.uk
Contact information
Public
166-220 Holloway Rd
London
N7 8DB
United Kingdom
 ORCID ID |
0000-0001-7637-068X |
|---|---|
| Phone | +44 (0)20 7133 2783 |
| j.webb1@londonmet.ac.uk |
Scientific
166-220 Holloway Rd
London
N7 8DB
United Kingdom
| Phone | +44 (0)20 7133 2783 |
|---|---|
| j.webb1@londonmet.ac.uk |
Study information
| Study design | Randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | 39949_PIS.pdf |
| Scientific title | A randomized control trial, with embedded process evaluation, to examine the effects of a digital web-based intervention on the physical activity of people with a musculoskeletal condition |
| Study acronym | LondonMetVa |
| Study objectives | It is hypothesized that a digital web-based intervention will improve physical activity in people with musculoskeletal conditions over no intervention. |
| Ethics approval(s) | Approved 04/03/2021, London Metropolitan University – School of Social Sciences and Professions – Research Ethics Committee (London Metropolitan University, School of Social Sciences and Professions, 166-220 Holloway Road, London, N7 8DB, UK, +44 (0)20 7423 000; research@londonmet.ac.uk), ref: SSPR-028 |
| Health condition(s) or problem(s) studied | Musculoskeletal conditions |
| Intervention | A two-arm randomised control trial is planned with a sample of 712 participants (306 in each arm, based on an estimated decrease in those classified inactive in the intervention group from 33% to 25%; alpha of 0.05; powered to 80%). Participants will be recruited through Facebook adverts. Those that express an interest will be sent further participant information, with consent provided digitally. Recruited participants will be randomised using simple randomisation into a control arm and an intervention arm. The intervention arm will receive a 12-week online physical activity programme consisting of 12 x 30-45 minute weekly exercise videos, with access to a Facebook group, an online forum, and a printable activity tracker; the control arm will not receive the intervention and will be sent the physical activity programme after 3 months. The intervention and control arms will be followed up at 3 months to assess outcomes. Additional follow-up will take place, in the intervention group, at 6 months to assess the maintenance of any changes. Data collection will be web-based. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Physical activity measured using the Sport England Active Lives questionnaire (short version) at baseline, weeks 1 through 13 and at 6 months 2. Step count measured using smartphone accelerometer data (for participants with a smartphone) using the ‘Pedometer α - Step Counter’ app at baseline, weeks 1 through 13 and at 6 months |
| Secondary outcome measures | 1. Health-related quality of life measured using the EQ5d-5L at baseline, weeks 1 through 13 and at 6 months 2. The capability, opportunity and motivation to be physically active assessed using a bespoke six-item questionnaire at baseline, weeks 1 through 13 and at 6 months |
| Overall study start date | 20/11/2020 |
| Completion date | 30/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 712 |
| Total final enrolment | 403 |
| Key inclusion criteria | 1. People living with a musculoskeletal condition 2. Aged 18 years or over 3. Who are not active to 150 minutes a week 4. Can read English 5. Able to provide consent 6. Have an active e-mail account 7. Have a smartphone |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 06/09/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
N7 8DB
United Kingdom
Sponsor information
University/education
166-220 Holloway Road
London
N7 8DB
England
United Kingdom
| Phone | +44 (0)20 7423 0000 |
|---|---|
| d.stewart@londonmet.ac.uk | |
| Website | https://www.londonmet.ac.uk/ |
"ROR" |
https://ror.org/00ae33288 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A study protocol has not been published and will be made available as an additional document by the end of September 2021. There is a plan to disseminate the study findings through a report (to be used by the charity funding this research) and through academic publications and conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Justin Webb (j.webb1@londonmet.ac.uk). Participants will provide consent for anonymised data to be used in future studies that have received all ethical, legal and regulatory approvals. Anonymised quantitative data will be available for all participants on the primary and secondary outcome measures at baseline, weeks 1 through 13 and 6 months. The data will become available following completion and write up of the research, anticipated to be June 2022 and will be made available for a period of 12 months. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 29/07/2021 | No | Yes | ||
| Results article | 04/03/2023 | 26/11/2024 | Yes | No |
Additional files
Editorial Notes
26/11/2024: Publication reference added.
30/09/2021: The total final enrolment number has been added.
02/08/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 09/08/2021 to 01/08/2021.
2. The recruitment end date was changed from 31/08/2021 to 06/09/2021.
3. The overall trial end date was changed from 30/09/2021 to 30/09/2022.
4. The intention to publish date was changed from 31/07/2022 to 31/07/2023.
5. Acronym added.
29/07/2021: Trial's existence confirmed by the London Metropolitan University – School of Social Sciences and Professions – Research Ethics Committee.
