Promoting Engagement in Physical Activity in Early Rheumatoid Arthritis: Proof of Concept Study

NCT04321798 | Completed

• 1 other identifier: HAS.17.04.144
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

People with rheumatoid arthritis have indicated that they would like better support to remain physically active following diagnosis and would welcome a physical activity programmes delivered outside of a secondary care setting by a physiotherapist. With patient input, and based upon previous research in other long term conditions, a physical activity intervention was developed by the researchers for delivery by musculoskeletal physiotherapists in a primary care setting. This proposed proof of concept study will investigate the new intervention and inform a future randomised controlled pilot trial. Four Band 6 musculoskeletal physiotherapists will be trained to deliver the intervention. Subsequently up to 32 patients with a recent diagnosis of rheumatoid arthritis (6 -24 months previously) will be recruited. Each physiotherapist will deliver the 12-week intervention package to a group of 6-8 participants. The participants will be asked to complete some outcome measures at the beginning of the 12-week intervention and again at the end. Following the 12-week programme some of the patients will be asked what they thought of the programme and the outcome measures and whether they have any suggestions for improvement. Those that did and did not complete the programme will be included to ensure a wide range of views. The treating physiotherapists will also be asked about their experiences of delivering the programme as well as what they thought of the training. Based upon these findings the programme will be refined and if appropriate further funding sought to carry out a pilot randomised controlled trial.

Conditions

Rheumatoid Arthritis

Keywords

fatigue; physical activity; quality of life; function

Outcome Measures

Primary Outcomes (1)

• Intervention Attendance

  minimum 0 maximum 5; higher is better

  12 weeks

Secondary Outcomes (8)

• International Physical Activity Questionnaire - Short Form

  7 days

• 6-minute walk distance

  6 minutes

• modified Health Assessment Questionnaire

  7 days

• Bristol Rheumatoid Arthritis Fatigue - Numerical Rating Scales

  7 days

• Self-efficacy for Exercise

  7-days

Study Arms (1)

Physical Activity

EXPERIMENTAL

Promoting Engagement in Physical Activity

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

Four group sessions and one individual session delivered over a period of 12 weeks in a primary care setting. Each session includes patient education and support for behaviour change as well as a supervised practical exercise component. The intervention is based upon a combination of self-determination theory and COM-B framework (capability, opportunity, motivation and behaviour) and employs motivational interviewing techniques.

Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with RA diagnosed in the previous 6-24 months. Able to undertake a PA programme. Able to understand and speak English. Able to understand the purpose of the research Provides informed consent.

You may not qualify if:

• Diagnosis of RA less than 6 months or more than 2 years previously. Unable to participate for medical reasons.

Sponsors & Collaborators

• University of the West of England: lead

Study Sites (1)

University of the West of England

Bristol, BS16 1DD, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Fatigue; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: March 25, 2020
• Study Start: August 1, 2017
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)