ArthritisMAintAinNCT06842550
MAintAin Activity in Arthritis: A Feasibility Study
A study testing MAintAin Activity with Arthritis in people with Arthritis, run by Royal College of Surgeons, Ireland.
Trial summary
Best practice guidelines across the world always recommend those living with arthritis to be physically active. Research shows that being active can help people living with arthritis to do the things that they want to do for longer, reduce pain, improve quality of life and protect against getting other health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- MAintAin Activity with Arthritis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Aoife Stephenson, PhD contact
About this study
Best practice guidelines across the world always recommend those living with arthritis to be physically active. Research shows that being active can help people living with arthritis to do the things that they want to do for longer, reduce pain, improve quality of life and protect against getting other health conditions such as heart disease, lung disease and cancer. Whilst various exercise programmes support people with arthritis to be active most individuals reduce their level of PA after completion of a prescribed programme. Staying active in the longer-term is more difficult and there is often a decrease in activity over time. Research has shown that exercise programmes helping people to become active, such as exercise classes, may not always have the right approach and focus during the programme to help people to stay active long-term. It is important to understand if people with arthritis can be supported to maintain their activity levels well in to the future. The investigators have already spoken to people living with arthritis, people involved in arthritis care and those involved in promoting physical activity. The research team brought their feedback and the scientific literature together and shaped a new intervention that suits the needs of people with arthritis and helps them to continue to be physically active. The investiagtors will now ask people living with arthritis to try out the new intervention.
Participants will receive up to five coaching sessions that aim to support people with arthritis to maintain their PA after exiting a structured exercise programme. Sessions will be delivered within community venues in a group setting by a trained provider. Sessions will last approximately between 60 and 90 minutes and will be delivered over a period of approximately 4-months.
Read more
Participants may receive a smartwatch with an inbuilt step counter such as Fitbit and diary to record their daily steps or physical activity minutes. The diary will also be used to record physical activity maintenance goals, complete action plans and self-monitor progress to build new habits. Participants can continue to use their own smartwatch if they have one.
The research team are interested to know if the programme has any effect on the amount of activity people do over time as well as looking at factors which can help with the understanding of 'why' or 'why not' a PA intervention may have worked.
- Conditions
- Arthritis
- Being tested
- MAintAin Activity with Arthritis
- Keywords
- Arthritis, Physical Activity Maintenance, Feasibility, Health coaching
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAintAin Activity with ArthritisBehavioural
Participants will receive up to five health coaching sessions led by a trained provider. The aim is to motivate people to meet their physical activity goals, look at their options, make choices and plans, identify challenges, and help them through these changes related to their physical activity and maintenance. Session 1: One to one session with a physical activity coach Session 2-5: Group sessions with approx. 8-10 other people living with arthritis. In the sessions participants will: • Set, reflect and adapt your activity goals • Learn to problem solve • Develop action plans to build new habits. • Learn about opportunities such as walking groups, aqua aerobics and yoga classes are available in your community • Have the support of peers in the group. Please note that these sessions are not exercise classes.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Maintenance Intervention | Experimental | This is a one armed, non controlled study. Participants will receive up to five health coaching sessions led by a trained provider. The aim is to motivate people to meet their physical activity goals, look at their options, make choices and plans, identify challenges, and help them through these changes related to their physical activity and maintenance. Session 1: One to one session with a physical activity coach Session 2-5: Group sessions with approx. 8-10 other people living with arthritis. In the sessions participants will: • Set, reflect and adapt your activity goals • Learn to problem solve • Develop action plans to build new habits. • Learn about opportunities such as walking groups, aqua aerobics and yoga classes are available in your community • Have the support of peers in the group. Please note that these sessions are not exercise classes. Receives: Behavioral: MAintAin Activity with Arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interview
Interviews with participants and providers to explore their needs and expectations (pre) and how/if they were met (post)
Measured: pre (week zero) and post (week 17)
Secondary outcomes (8)
Physical Activity
Physical activity data from an accelerometer
Measured: pre (week 0) and post (week 17)
Relapse Self Efficacy Questionnaire
To measure how confident a person is about restarting physical activity
Measured: pre (week 0) and post (week 17)
Maintenance Self Efficacy Questionnaire
To measure how confident a person is about staying physical activity
Measured: pre (week 0) and post (week 17)
Self-Report Behavioural Automaticity Index
To measure physical activity automaticity
Measured: pre (week 0) and post (week 17)
Physical Activity Behaviour Self-Evaluation Questionnaire
To measure opportunity in relation to physical activity
Measured: pre (week 0) and post (week 17)
Adapted Action and Coping Planning Questionnaire
To measure intentions and plans around physical activity
Measured: pre (week 0) and post (week 17)
PHYSICAL ACTIVITY REGULATIONS QUESTIONNAIRE (BREQ-3)
To measure why someone participates why they engage in physical activity
Measured: pre (week 0) and post (week 17)
Satisfaction with intervention
To measure satisfaction with intervention, using bespoke satisfaction questions and scale (1-5, where 1 is "very dissastified" and 5 is "very satisfied")
Measured: post (week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842550
- Sponsor's protocol ID
- 24-242
- Other IDs
- HRCI-HRB-2022-010
- Acronym
- MAintAin
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAintAin Activity in Arthritis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06842550
- Acronym / sponsor ID
- MAintAin / 24-242
- Conditions
- Arthritis
- Keywords
- Arthritis, Physical Activity Maintenance, Feasibility, Health coaching
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Feb 2025 (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.
Best practice guidelines across the world always recommend those living with arthritis to be physically active. Research shows that being active can help people living with arthritis to do the things that they want to do for longer, reduce pain, improve quality of life and protect against getting other health conditions such as heart disease, lung disease and cancer. Whilst various exercise programmes support people with arthritis to be active most individuals reduce their level of PA after completion of a prescribed programme. Staying active in the longer-term is more difficult and there is often a decrease in activity over time. Research has shown that exercise programmes helping people to become active, such as exercise classes, may not always have the right approach and focus during the programme to help people to stay active long-term. It is important to understand if people with arthritis can be supported to maintain their activity levels well in to the future. The investigators have already spoken to people living with arthritis, people involved in arthritis care and those involved in promoting physical activity. The research team brought their feedback and the scientific literature together and shaped a new intervention that suits the needs of people with arthritis and helps them to continue to be physically active. The investiagtors will now ask people living with arthritis to try out the new intervention.
Participants will receive up to five coaching sessions that aim to support people with arthritis to maintain their PA after exiting a structured exercise programme. Sessions will be delivered within community venues in a group setting by a trained provider. Sessions will last approximately between 60 and 90 minutes and will be delivered over a period of approximately 4-months.
Participants may receive a smartwatch with an inbuilt step counter such as Fitbit and diary to record their daily steps or physical activity minutes. The diary will also be used to record physical activity maintenance goals, complete action plans and self-monitor progress to build new habits. Participants can continue to use their own smartwatch if they have one.
The research team are interested to know if the programme has any effect on the amount of activity people do over time as well as looking at factors which can help with the understanding of 'why' or 'why not' a PA intervention may have worked.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Maintenance Intervention | Experimental | Behavioral: MAintAin Activity with ArthritisThis is a one armed, non controlled study. Participants will receive up to five health coaching sessions led by a trained provider. The aim is to motivate people to meet their physical activity goals, look at their options, make choices and plans, identify challenges, and help them through these changes related to their physical activity and maintenance. Session 1: One to one session with a physical activity coach Session 2-5: Group sessions with approx. 8-10 other people living with arthritis. In the sessions participants will: • Set, reflect and adapt your activity goals • Learn to problem solve • Develop action plans to build new habits. • Learn about opportunities such as walking groups, aqua aerobics and yoga classes are available in your community • Have the support of peers in the group. Please note that these sessions are not exercise classes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MAintAin Activity with ArthritisParticipants will receive up to five health coaching sessions led by a trained provider. The aim is to motivate people to meet their physical activity goals, look at their options, make choices and plans, identify challenges, and help them through these changes related to their physical activity and maintenance. Session 1: One to one session with a physical activity coach Session 2-5: Group sessions with approx. 8-10 other people living with arthritis. In the sessions participants will: • Set, reflect and adapt your activity goals • Learn to problem solve • Develop action plans to build new habits. • Learn about opportunities such as walking groups, aqua aerobics and yoga classes are available in your community • Have the support of peers in the group. Please note that these sessions are not exercise classes. | Behavioural | Physical Activity Maintenance Intervention |
Primary outcome
Qualitative Interview
Time frame: pre (week zero) and post (week 17)
Interviews with participants and providers to explore their needs and expectations (pre) and how/if they were met (post)
8 secondary outcomes
Physical Activity
Time frame: pre (week 0) and post (week 17)
Relapse Self Efficacy Questionnaire
Time frame: pre (week 0) and post (week 17)
Maintenance Self Efficacy Questionnaire
Time frame: pre (week 0) and post (week 17)
Self-Report Behavioural Automaticity Index
Time frame: pre (week 0) and post (week 17)
Physical Activity Behaviour Self-Evaluation Questionnaire
Time frame: pre (week 0) and post (week 17)
Adapted Action and Coping Planning Questionnaire
Time frame: pre (week 0) and post (week 17)
PHYSICAL ACTIVITY REGULATIONS QUESTIONNAIRE (BREQ-3)
Time frame: pre (week 0) and post (week 17)
Satisfaction with intervention
Time frame: post (week 17)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- MAintAin Activity in Arthritis: A study protocol of the co-development and feasibility testing of a physical activity maintenance interventionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Arthritis
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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.
Aoife Stephenson, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing MAintAin Activity with Arthritis in people with Arthritis, run by Royal College of Surgeons, Ireland.
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 0 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: opening soon, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne McDonough, PhD (+353 1 402 2100, suzannemcdonough@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Interview (time frame: pre (week zero) and post (week 17)). 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 24 Feb 2025.