Clinical trial NCT03644160: A Physiotherapist Led Intervention to Promote Physical Activity in Rheumatoid Arthritis - a Pilot Study
Official title: A Physiotherapist Led Intervention to Promote Physical Activity in Rheumatoid Arthritis - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Physical activity
Behaviour Change
Physiotherapy
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre randomised pilot study
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis (RA), a chronic, inflammatory condition with increased mortality from cardiovascular disease, is associated with high health care related costs and decreased productivity. Currently, nonpharmacological management guidelines recommend increasing low levels of physical activity in this group to improve health including cardiovascular health, yet research has shown that people who have RA have reduced levels of PA. Interventions targeting PA behaviour in this population have had limited effect to date due to lack of patient involvement in designing the intervention, poor measurement of PA, lack of behaviour change theory underpinning the intervention and have tended to include people who already have some level of PA. Work to underpin a robust intervention to improve PA in this group has been undertaken by members of this study group including validation of an objective measure PA in RA and interviews with people who have RA and rheumatology health professionals to aid in designing an intervention to promote PA.

The aim of this pilot randomised controlled trial (RCT) is to examine the feasibility of a physiotherapist led, behaviour change theory informed, PA intervention to promote PA in people who have RA who have low levels of current PA. This pilot study will determine the rate of recruitment to the study and also determine the acceptability of the intervention to the participants as well as test the feasibility of the secondary disease/PA focused outcome measures.

Participants will be recruited from rheumatology clinics in a large teaching hospital. Participants meeting inclusion criteria will be randomised into an eight week PA intervention (four sessions delivered over an eight week period by a trained physiotherapist) or a control group (PA information leaflet). This pilot randomised study will provide valuable information for the scaling up of a primary care based intervention for this important patient group and in doing so provide an achievable, pragmatic intervention for busy clinicians, who need feasible interventions to appropriately manage complex chronic conditions like RA in a busy primary care setting.

Detailed description: Rheumatoid Arthritis (RA) affects approximately 0.5% of the adult population worldwide. In Ireland c46,000 people have RA, with c2,000 new cases diagnosed annually. Cardiovascular disease (CVD) , infections and lymphoma occur more frequently in this population with increased mortality rates present1. Physical activity (PA) is very important in the management of RA and is an essential in reducing the risk of CVD, improving disease symptoms and quality of life. However, people who have RA tend to have low PA levels, thus improving PA levels is important. Previous interventions which have targeted PA in people who have RA have had limited success in increasing and maintaining PA behaviour change (BC) in the longer term. Reasons for this limited success include short intervention time, inadequate involvement of participants in designing the study, lack of objective measurement of PA and lack of a BC theoretical underpinning. Thus, better intervention design through the incorporation of appropriate BC theory is necessary. Adopting the Behaviour Change Wheel (BCW), facilitates the identification of factors which should be targeted in a BC intervention to promote PA. In order to design a robust intervention to address the issues above, the applicants undertook extensive systematic literature reviewing, objective PA measurement validation and qualitative interviews with people with RA and with rheumatology health professionals, guided by the Medical Research council framework for complex interventions. A pilot intervention is now proposed building on that work to determine the feasibility of a physiotherapist led BC intervention to promote PA in people with RA who have low levels of PA.

The aim of this pilot study is to determine the feasibility and acceptability of a physiotherapist led BC intervention to promote PA in people with RA who are insufficiently physically active compared to a control group who receive a leaflet on PA.

Ethical Approval: approval will be sought in advance of the study start date from Health Service Executive Research ethics committee University Hospitals Limerick.

Trial design: single-centre randomised pilot study, incorporating qualitative interviews to examine acceptability, comparing the intervention with a control.

Methods: Participants, interventions, and outcomes Study setting - Academic teaching hospitals group in Mid-West of Ireland

Interventions The intervention group (group A) will receive an 8 week individualised, tailored behaviour change intervention to promote PA and an information booklet about PA with a physiotherapist with training in behaviour change techniques and motivational interviewing. Using a range of behaviour change and self-regulation techniques (eg goal-setting, self-monitoring), participants will be guided towards PA maintenance at the end of the 8 weeks. In addition, participants will be signposted to PA classes, facilities and resources in the local community.

The control group (Group B) will receive the same information booklet about PA only. Both groups will continue with their routine care for their condition throughout the study period.

Primary outcome measures will be:

1. Recruitment rate - the rate of participants recruited to the study versus total potential participants
2. Retention rate - the number of participants who complete baseline measures and at week 8

Sample Size A target of 40 participants, with 20 participants in both the control and intervention groups. This sample size is expected to provide sufficient data to meet the primary outcomes. A definitive sample size of a large-scale RCT will be determined from the results of this trial.

Data analysis Descriptive statistics will be used to determine the recruitment and retentions rates and to measure change in outcome measures from baseline to T1 and T2. Thematic analysis will be used to analyse the transcribed interviews

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Rheumatoid arthritis
* Age over 18 years
* Classified using Godin-Shephard Leisure-Time Physical Activity Questionnaire as insufficiently active

Exclusion Criteria:

* Aged less than 18 years
* People who require a mobility aid to mobilise in their activities of daily living (ADLs)
* Pregnancy
* Meeting aerobic physical activity recommendations already

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline
measure: Retention rate
timeFrame: At week 12
Secondary outcomes:
measure: Physical activity - objective
timeFrame: Baseline, 8 and 24-week follow-up
measure: Physical activity - self-report
timeFrame: Baseline, 8 and 24-week follow-up
measure: Behaviour Change
timeFrame: Baseline, 8 and 24-week follow-up
measure: Quality of Life in Rheumatoid Arthritis
timeFrame: Baseline, 8 and 24-week follow-up
measure: Pain over past 7 days
timeFrame: Baseline, 8 and 24-week follow-up
measure: Fatigue
timeFrame: Baseline, 8 and 24-week follow-up
measure: Function
timeFrame: Baseline, 8 and 24-week follow-up
measure: Sleep
timeFrame: Baseline, 8 and 24-week follow-up
measure: Disease activity profile
timeFrame: Baseline, 8 and 24-week follow-up
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick/University Hospitals Limerick
Study officials:
affiliation: University of Limerick
name: Norelee Kennedy, PhD
role: PRINCIPAL_INVESTIGATOR
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