MedTrace Logo

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

NCT04321798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-03-25

No results posted yet for this study

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

Interventions

BEHAVIORAL

Physical Activity

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.

Sponsors & Collaborators

  • University of the West of England

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-06-29
Completion
2018-06-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321798 on ClinicalTrials.gov