OsteoarthritisNCT05937542
A Qualitative Investigation of CLEAT Participants
An observational study of Osteoarthritis, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Qualitative Investigation of Participant Experiences
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2023to Dec 2024
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Anyone not previously part of the NIHR-funded CLEAT trial. -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Bournemouth University
Bournemouth
Tim Rees, PhD, trees@bournemouth.ac.uk
Suzy Wignall, clinicalresearch@bournemouth.ac.uk
About this study
Official title: 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.
- Conditions
- Osteoarthritis
- Being tested
- Qualitative Investigation of Participant Experiences
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Investigation of Participant ExperiencesBehavioural
There is no intervention. This is a retrospective qualitative study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Experiences
Participant experiences generated via qualitative data
Measured: One data collection point via interview (3-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start5 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Tim Rees, PhD, Study director, Professor in Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937542
- Sponsor's protocol ID
- 330860
- Status last verified
- Jan 2024
- First submitted
- 27 Jun 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Investigation of the Experiences of Participants Undertaking a CycLing and EducATional (CLEAT) Programme for the Treatment of Hip Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05937542
- Acronym / sponsor ID
- 330860
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Anyone not previously part of the NIHR-funded CLEAT trial. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative Investigation of Participant ExperiencesThere is no intervention. This is a retrospective qualitative study. | Behavioural | – |
Primary outcome
Participant Experiences
Time frame: One data collection point via interview (3-6 months)
Participant experiences generated via qualitative data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Rees, PhD study director
Professor in Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Bournemouth 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 6 inclusion and 1 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 12 Aug 2024. 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 Tim Rees, PhD (+441202961200, trees@bournemouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Experiences (time frame: One data collection point via interview (3-6 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 12 Aug 2024.