MAintAin Activity in Arthritis: A Feasibility Study (MAintAin)

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 Overview

• Status: Not yet recruiting
• Conditions: Arthritis
• Intervention / Treatment: Behavioral: MAintAin Activity with Arthritis

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzanne McDonough, PhD; Phone Number: +353 1 402 2100; Email: suzannemcdonough@rcsi.ie
• Study Contact Backup: Name: Aoife Stephenson, PhD; Email: aoifestephenson@rcsi.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Those who have exited from a supervised group-based exercise programme for arthritis.

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Exclusion Criteria: Those aged under 18 years

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Physical Activity Maintenance Intervention; 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.

Behavioral: MAintAin Activity with Arthritis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Interview	Interviews with participants and providers to explore their needs and expectations (pre) and how/if they were met (post)	pre (week zero) and post (week 17)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Physical activity data from an accelerometer	pre (week 0) and post (week 17)
Relapse Self Efficacy Questionnaire	To measure how confident a person is about restarting physical activity	pre (week 0) and post (week 17)
Maintenance Self Efficacy Questionnaire	To measure how confident a person is about staying physical activity	pre (week 0) and post (week 17)
Self-Report Behavioural Automaticity Index	To measure physical activity automaticity	pre (week 0) and post (week 17)
Physical Activity Behaviour Self-Evaluation Questionnaire	To measure opportunity in relation to physical activity	pre (week 0) and post (week 17)
Adapted Action and Coping Planning Questionnaire	To measure intentions and plans around physical activity	pre (week 0) and post (week 17)
PHYSICAL ACTIVITY REGULATIONS QUESTIONNAIRE (BREQ-3)	To measure why someone participates why they engage in physical activity	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")	post (week 17)

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland

Publications and helpful links

Helpful Links

• MAintAin Activity in Arthritis: A study protocol of the co-development and feasibility testing of a physical activity maintenance intervention

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Arthritis; Feasibility; Health coaching; Physical Activity Maintenance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Benzocaine
• Other Study ID Numbers: 24-242; HRCI-HRB-2022-010 (Other Grant/Funding Number: HRB HCRI Arthritis Ireland)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No