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Musculoskeletal DiseasesNCT05286606

Smart Community Rehabilitation

An observational study of Musculoskeletal Diseases, run by Oxford Brookes University at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Musculoskeletal (MSK) conditions affect 18.8 million people in the UK , accounting for 30% of all GP appointments with combined cost to the NHS of £5bn per year.. It is a highly prevalent and growing umbrella of pain, mobility, function, and inflammatory disorders that account for 40% of all sick leave. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Diseases
What is being tested?
Exercise and Social Groups
How many people
400 participants
Where
1 siteUnited Kingdom
Study dates
14 Feb 2022to 14 Sep 2022
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Users with MSK using the exercise program: In Phase II work package 1: recruitment of the first group of people will be recruited via charities who are collaborating and participating in the Good Boost exercise program, all will participate in a three-month pilot of the beta-app and up to n = 40 of these will be invited to pre and post beta-testing focus groups. Facilitators facilitating the program: The facilitators for the virtual groups will be recruited equally by the charities and will work for GoodBoost to facilitate the study for the app users. Health Care Professionals (HCP): The focus group will also be recruited at this phase . Ideally initially recruited facilitators and HCPs will complete all phases of the research but additional will be recruited as needed for example in phase III more facilitators possibly will be recruited if user sample size is large. They can be study First testers as a volunteer and will take part in a focus group with two sessions.

Who may be able to join

  • Aged over 18
  • Living with an MSK condition
  • Is happy to take part in exercise at home
  • Has not been advised by a health care professional to stop/avoid physical activity and complete the Canadian Physical Activity Questionnaire PARQ
  • Has an apple (iOS) or Android phone to download the app.
  • Is happy to take part in the pilot for the duration of the 3-month pilot (if they are signing up for the first quarter (Oct-Jan) or second quarter (Jan-Apr). Over this time that participants will average at least one 30-minute session every two weeks
Show all 19Show fewer
  • Is happy to provide feedback on their experience to improve the digital service (through up to 2x virtual focus groups and 2 x online questionnaires)
  • Is happy to volunteer and consent for their anonymised data to be included in the project research evaluation
  • 2.2.2 Virtual group facilitators (Facilitators)
  • Sample size (Recruitment phase I; up to n = 10, Recruitment phase III up to 20 depending on requirement based on user recruitment).
  • These are recruited by the charities, internally and thus inclusion is based on the specific charities
  • undergone the facilitators training course.
  • 2.2. 3 Focus group
  • Sample size (Recruitment phase I; up to n = 10. Charities have their own clinical experts and recruitment will from their initially (no advert needed. This group are not study participants but could take part as first app testers to feedback and help in the design) 2.2.2 Virtual group facilitators (Facilitators)
  • Sample size (Recruitment phase I; up to n = 10, Recruitment phase III up to 20 depending on requirement based on user recruitment).
  • These are recruited by the charities, internally and thus inclusion is based on the specific charities
  • undergone the facilitators training course.
  • 2.2. 3 Experts (HCP)
  • Healthcare professional involved in treatment of MSK condition

Who cannot join

  • not meeting the inclusion criteria for each group Under 18 years old Not being familiar with technology
  • -

Trial locations and contacts

1 site in 1 country.

helen dawes, phd contact

01865483293

h.dawes@exeter.ac.uk

mae mansoubi, phd contact

m.mansoubi@exeter.ac.uk

United Kingdom1 site, 1 recruiting
  • Oxford Brookes

    Oxford, Ox3 0bp

    Mae Mansoubi, PhD, mmansoubi@brookes.ac.uk

    Helen Dawes, PhD, hdawes@brookes.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Transforming Older Adult Disability Through Virtual, Peer-Led Community Rehabilitation: Led By MSK Charities

Musculoskeletal (MSK) conditions affect 18.8 million people in the UK , accounting for 30% of all GP appointments with combined cost to the NHS of £5bn per year.. It is a highly prevalent and growing umbrella of pain, mobility, function, and inflammatory disorders that account for 40% of all sick leave. Older adults experience almost 2/3rd of MSK prevalence and BAME groups experience high prevalence of certain MSKDs with access inequalities in MSK care and poorer outcomes (Versus Arthritis, 2019). Suffering from a chronic MSK condition is associated with decreased functional capacity, reduction in physical activity and mobility which ultimately results in high costs to health services. In the current climate, the effect of social isolation and redirecting of health care services may prove to expedite the effect of an MSK condition on functional capacity.

There is a large body of evidence for the use of physical activity demonstrates the effectiveness of exercise to treat, manage and prevent MSK conditions . Exercise is one of the primary tools utilised by Physiotherapists throughout the nation and the 'State of Musculoskeletal Health 2019' published by Versus Arthritis cites physical inactivity as a core contributor in growing MSK prevalence and the benefits of exercise for MSK conditions . Access to Physiotherapy services, either due to waiting times, high cost of private care or the non-proximity or remote access to services like Escape Pain are barriers for people living with MSK conditions. Additionally, the primary barrier to anyone living with an MSK condition to being active is pain . As a result, the use of mobile applications to deliver exercise programmes has increased, however, there is a lack of provision for the population of people with MSK problems. Research evidence demonstrates that exercise is highly effective in supporting people living with a joint or pain condition to reduce pain, improve mobility and improve the overall quality of life. However, in the current effect of Covid-19, many people with MSK problems no longer have access to physiotherapy as well as social isolation limiting the opportunities to engage in meaningful physical activity. Trusted by clinicians and patients, MSK charities are the foremost support service to deliver care closer to home, aligning with the NHS strategy.

This project will co-design a solution that is accessible and inclusive by combining cutting-edge technology and MSK charities' networks and expertise, to deliver virtual community MSK rehab, providing an innovative and cost-effective solution to the significant UK and global health challenge. Already overburdened, NHS MSK services are even more pressured due to COVID-19. The project will develop and validate a commercially scalable rehab solution to reduce this pressure. The solution empowers MSK charities to deliver rehab services to beneficiaries through existing, leading-edge AI-powered physiotherapy software. This not only plugs the gap left by long Physiotherapy waiting lists but serves to improve upon existing services by increasing reach and engagement through its community and peer-support aspects. Insight from MSK charities has demonstrated the need for emotional, peer-led and practical rehab solutions that encourage and support patients. The project will be game-changing in driving improved health outcomes for patients and reducing NHS burden and costs.

Read the detailed description

1.2.1 Background: Musculoskeletal (MSK) conditions affect 18.8 million people in the UK , accounting for 30% of all GP appointments with combined cost to the NHS of £5bn per year. It is a highly prevalent and growing umbrella of pain, mobility, function, and inflammatory disorders that account for 40% of all sick leave. Older adults experience almost 2/3rd of MSK prevalence and BAME groups experience high prevalence of certain MSKDs with access inequalities in MSK care and poorer outcomes (Versus Arthritis, 2019). Suffering from a chronic MSK condition is associated with decreased functional capacity, reduction in physical activity and mobility which ultimately results in high costs to health services. In the current climate, the effect of social isolation and redirecting of health care services may prove to expedite the effect of an MSK condition on functional capacity.

There is a large body of evidence for the use of physical activity demonstrates the effectiveness of exercise to treat, manage and prevent MSK conditions. Exercise is one of the primary tools utilised by Physiotherapists throughout the nation and the 'State of Musculoskeletal Health 2019' published by Versus Arthritis cites physical inactivity as a core contributor in growing MSK prevalence and the benefits of exercise for MSK conditions. Access to Physiotherapy services, either due to waiting times , high cost of private care or the non-proximity or remote access to services like Escape Pain are barriers for people living with MSK conditions. Additionally, the primary barrier to anyone living with an MSK condition to being active is pain. As a result, the use of mobile applications to deliver exercise programmes has increased, however, there is a lack of provision for the population of people with MSK problems. Research evidence demonstrates that exercise is highly effective in supporting people living with a joint or pain condition to reduce pain, improve mobility and improve the overall quality of life. However, in the current effect of Covid-19, many people with MSK problems no longer have access to physiotherapy as well as social isolation limiting the opportunities to engage in meaningful physical activity. Trusted by clinicians and patients, MSK charities are the foremost support service to deliver care closer to home, aligning with the NHS strategy.

This project will co-design a solution that is accessible and inclusive by combining cutting-edge technology and MSK charities' networks and expertise, to deliver virtual community MSK rehab, providing an innovative and cost-effective solution to the significant UK and global health challenge. Already overburdened, NHS MSK services are even more pressured due to COVID-19. The project will develop and validate a commercially scalable rehab solution to reduce this pressure. The solution empowers MSK charities to deliver rehab services to beneficiaries through existing, leading-edge AI-powered physiotherapy software. This not only plugs the gap left by long Physiotherapy waiting lists but serves to improve upon existing services by increasing reach and engagement through its community and peer-support aspects. Insight from MSK charities has demonstrated the need for emotional, peer-led and practical rehab solutions that encourage and support patients. The project will be game-changing in driving improved health outcomes for patients and reducing NHS burden and costs.

1.2.2 Aim: This research project aims to complete product testing, co-production, and research to achieve regulatory approval for public rollout and commercialisation to create a publicly accessible product which will address clinical rehab needs for MSKDs and reduce health inequality. The project will determine the usability, acceptability, and feasibility for use of the developed App.

1.2.3 Objectives: There are two objectives in this study. First one is the usability of the app and second one is the app feasibility

Usability: To discover the barriers and facilitators and potential of using and adopting virtual group digital technology in the management of MSK condition.

Feasibility: to determine the safety, usability and potential benefit of the app

Being tested
Exercise and Social Groups
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise and Social GroupsBehavioural

    Participants in the exercise program, which will include a 2-3 time a week 30-45-minute group exercise programme over a 3-month period, 2 x three months. The intervention consists of a 30-45-minute exercise programme. The exercise programme is created by the Good Boost AI based on pre-registration questions or premade sessions, these are either generic sessions with options of strength, aerobic flexibility and balance/coordination exercise with intensity adjusted according to the user's feedback.

    In this program the intervention content is standardised through the Good Boost exercise program. The standard program involves all users to be registered to a single group and to log on to the group, through, zoom, and the facilitator welcomes them. The group then performs the exercise programme they would like to do guided through the app, and afterwards they all meet on a group chat and get peer support.

Study groups in NCT05286606
Study groupRoleWhat they receive
Focus groupsHealth Care Professionals (HCP), facilitators, participants in the exercise program will be invited to participate in focus groups to comment on usability/acceptability.
App usersUsers of the exercise program with musculoskeletal conditions have been referred to the exercise program via the charities, all will be participating in a three-month program using the beta version of the app. They will be invited to participate in the program evaluation
Receives: Behavioral: Exercise and Social Groups
FacilitatorsFacilitators of the exercise program: The facilitators for the virtual groups have been recruited equally by the charities and are working for GoodBoost to facilitate the exercise program for the app users. They will be invited to participate in the program evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. We are performing a program evaluation of the Good Boost exercise program. The primary outcome is measuring the usability of the APP over the program.

    We are determining usability as measured by the number of sessions attended.

    Measured: 6 months

Secondary outcomes (9)
  1. Health related Quality of life (EQ 5D)

    Eq5d

    Measured: 6 months

  2. MSK condition musculoskeletal health Questionnaire (MSK-HQ)

    MSK condition musculoskeletal health Questionnaire (MSK-HQ)

    Measured: 6 month

  3. Physical activity International Physical activity questionnaire.(IPAQ

    Physical activity International Physical activity questionnaire.(IPAQ

    Measured: 6 month

  4. Functional capacity 2 sit to stand (30 sec)

    measured using an IMU sit to stand on the spot

    Measured: 6 month

  5. Functional capacity 3 Timed up and go (time) sec )

    measured over a 3 meter course using an IMU

    Measured: 6 month

  6. Accessiblity

    app usage using interviews and views and opininions

    Measured: 6 month

  7. Completion of outcome measures

    percentage of completion of the Health related Quality of life (EQ 5D), Physical activity International Physical activity questionnaire.(IPAQ) and MSK condition musculoskeletal health Questionnaire (MSK-HQ).

    Measured: 6 months

  8. recrtuitment rate

    recruitment rate of the number of people expressing an interest in using the app and registering on the study.

    Measured: 6 months

  9. Retention to the research measures

    retention as measured by completion outcome measures at follow up

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start14 Feb 2022
  3. Primary completion14 Jul 2022 (estimated)
  4. Study completion14 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05286606
Sponsor's protocol ID
UREC211525
Status last verified
Mar 2022
First submitted
7 Feb 2022
Last updated
18 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Musculoskeletal Diseases, run by Oxford Brookes University at 1 site 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 19 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact helen dawes, phd (01865483293, h.dawes@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

We are performing a program evaluation of the Good Boost exercise program. The primary outcome is measuring the usability of the APP over the program. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Mar 2022.

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