NCT05286606

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

February 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

February 7, 2022

Last Update Submit

March 9, 2022

Conditions

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (9)

  • Health related Quality of life (EQ 5D)

    6 months

  • MSK condition musculoskeletal health Questionnaire (MSK-HQ)

    6 month

  • Physical activity International Physical activity questionnaire.(IPAQ

    6 month

  • Functional capacity 2 sit to stand (30 sec)

    6 month

  • Functional capacity 3 Timed up and go (time) sec )

    6 month

  • +4 more secondary outcomes

Study Arms (3)

Focus groups

Health Care Professionals (HCP), facilitators, participants in the exercise program will be invited to participate in focus groups to comment on usability/acceptability.

App users

Users 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

Behavioral: Exercise and Social Groups

Facilitators

Facilitators 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

Interventions

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.

App users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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
  • 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
  • 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).
  • undergone the facilitators training course.
  • 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).
  • undergone the facilitators training course.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Brookes

Oxford, Ox3 0bp, United Kingdom

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

ExerciseSocial Group

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOrganizationsHealth Care Economics and Organizations

Study Officials

  • helen Dawes, phd

    Oxford Brookes University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

helen dawes, phd

CONTACT

mae mansoubi, phd

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

March 18, 2022

Study Start

February 14, 2022

Primary Completion

July 14, 2022

Study Completion

September 14, 2022

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations