- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05937542
A Qualitative Investigation of CLEAT Participants
August 9, 2024 updated by: Bournemouth University
A Qualitative Investigation of the Experiences of Participants Undertaking a CycLing and EducATional (CLEAT) Programme for the Treatment of Hip Osteoarthritis.
As the United Kingdom's National Health Service (NHS) waiting list soars above seven million people, with treatment wait times over two years, older people with chronic conditions face worsening symptoms, increased use of medications, more complicated surgeries with slower recovery, reduced quality of life, and loss of independence.
As part of its plans to tackle this crisis, the NHS promotes exercise as a "miracle cure" for arresting the progress of disease and helping disease management and recovery.
However, current plans promoting individual, home-based exercise, as well as on-site hospital-based programs of delivery, have met with only limited success, and face problems of decreased space, capacity, clinician time, as well as lack of knowledge and expertise with regard to effective behavior change.
We have developed a community-based group exercise programme for older people with hip osteoarthritis.
This community-based group exercise programme has successfully helped those with hip osteoarthritis (3.5 million over 45s in the UK) reduce pain and need for medication, as well as avoiding surgery, and has formed part of an NIHR trial examining the use of exercise and education versus standard physiotherapy care for the treatment of hip osteoarthritis.
In order to better understand the mechanisms of action of this programme, the present study will examine, via focus groups interviews, the experiences of participants who have undertaken the exercise and education programme.
The data generated from the focus groups will help to elucidate what "works" within the programme and will help inform future development of resources to support health professionals in providing exercise rehabilitation for older people with chronic conditions.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tim Rees, PhD
- Phone Number: +441202961200
- Email: trees@bournemouth.ac.uk
Study Contact Backup
- Name: Suzy Wignall
- Phone Number: +441202961200
- Email: clinicalresearch@bournemouth.ac.uk
Study Locations
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-
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Bournemouth, United Kingdom
- Recruiting
- Bournemouth University
-
Contact:
- Suzy Wignall
- Email: clinicalresearch@bournemouth.ac.uk
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Contact:
- Tim Rees, PhD
- Email: trees@bournemouth.ac.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Participants who had previously been part of the NIHR-funded trial into the effects of a cycling and educational intervention for people with hip osteoarthritis.
Description
Inclusion Criteria:
Participants who had previously been part of the NIHR-funded CLEAT trial. Those participants were defined as follows:
- Diagnosed with osteoarthritis of the hip as per NICE criteria.
- Male and female, aged 45 years and over
- Meeting the GP criteria for exercise referral
- Capable of giving informed consent
- Be able to understand English as necessary to benefit from the intervention, in the investigators' opinion.
Exclusion Criteria:
• Anyone not previously part of the NIHR-funded CLEAT trial. -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Experiences
Time Frame: One data collection point via interview (3-6 months)
|
Participant experiences generated via qualitative data
|
One data collection point via interview (3-6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Tim Rees, PhD, Professor in Sport
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
June 27, 2023
First Submitted That Met QC Criteria
July 6, 2023
First Posted (Actual)
July 10, 2023
Study Record Updates
Last Update Posted (Actual)
August 12, 2024
Last Update Submitted That Met QC Criteria
August 9, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 330860
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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