NCT03644160: PIPPRA

A Physiotherapist Led Intervention to Promote Physical Activity in Rheumatoid Arthritis - a Pilot Study

Completed NA Last updated 13 June 2022

What this trial tests

NA trial testing Physical activity and behaviour change in Rheumatoid Arthritis in 58 participants. Completed in 31 December 2021.

Timeline

1 October 2019

Primary endpoint
1 November 2021

31 December 2021

Quick facts

Lead sponsor	University of Limerick
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	58
Start date	1 October 2019
Primary completion	1 November 2021
Estimated completion	31 December 2021
Sites	1 location across Ireland

Drugs / interventions tested

• Physical activity and behaviour change

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

University of Limerick

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The impact of COVID-19 on clinical research: the PIPPRA and MEDRA experience.
   Larkin L, Raad T, Moses A, Fraser A, et al · · 2021 · cited 6× · PMID 38187120 · DOI 10.12688/hrbopenres.13283.2
2. Promoting physical activity in rheumatoid arthritis through a physiotherapist led behaviour change-based intervention (PIPPRA): a feasibility randomised trial.
   Larkin L, McKenna S, Pyne T, Comerford P, et al · · 2024 · cited 4× · PMID 38438576 · DOI 10.1007/s00296-024-05544-1