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

NCT03644160 | Completed

• 1 other identifier: PIPPRA-1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Physical activity; Behaviour Change; Physiotherapy

Outcome Measures

Primary Outcomes (2)

• Recruitment rate

  The rate of participants recruited to the study versus total potential participants

  Baseline

• Retention rate

  The number of participants who complete baseline measures at week 12

  At week 12

Secondary Outcomes (9)

• Physical activity - objective

  Baseline, 8 and 24-week follow-up

• Physical activity - self-report

  Baseline, 8 and 24-week follow-up

• Behaviour Change

  Baseline, 8 and 24-week follow-up

• Quality of Life in Rheumatoid Arthritis

  Baseline, 8 and 24-week follow-up

• Pain over past 7 days

  Baseline, 8 and 24-week follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Physical activity and behaviour change The intervention group (group A) will receive an 8 week individualised, tailored behaviour change intervention to promote PA and an information booklet about physical activity with a physiotherapist who has 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 physical activity maintenance at the end of the 8 weeks. In addition, participants will be signposted to physical activity classes, facilities and resources in the local community. This group will continue with their routine care for their condition throughout the study period.

Behavioral: Physical activity and behaviour change

Control Group

NO INTERVENTION

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

Interventions

Physical activity and behaviour change BEHAVIORAL

The intervention group (group A) will receive an 8 week individualised, tailored behaviour change intervention to promote PA and an information booklet about physical activity to include an initial 1:1 session 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 physical activity maintenance at the end of the 8 weeks. In addition, participants will be signposted to physical activity classes, facilities and resources in the local community. This group will continue with their routine care for their condition throughout the study period.

Intervention Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

University of Limerick/University Hospitals Limerick

Limerick, Ireland

Location

Related Publications (15)

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  PMID: 21665122 BACKGROUND

• Power D, Codd M, Ivers L, Sant S, Barry M. Prevalence of rheumatoid arthritis in Dublin, Ireland: a population based survey. Ir J Med Sci. 1999 Jul-Sep;168(3):197-200. doi: 10.1007/BF02945853.

  PMID: 10540788 BACKGROUND

• Peters MJ, Symmons DP, McCarey D, Dijkmans BA, Nicola P, Kvien TK, McInnes IB, Haentzschel H, Gonzalez-Gay MA, Provan S, Semb A, Sidiropoulos P, Kitas G, Smulders YM, Soubrier M, Szekanecz Z, Sattar N, Nurmohamed MT. EULAR evidence-based recommendations for cardiovascular risk management in patients with rheumatoid arthritis and other forms of inflammatory arthritis. Ann Rheum Dis. 2010 Feb;69(2):325-31. doi: 10.1136/ard.2009.113696. Epub 2009 Sep 22.

  PMID: 19773290 BACKGROUND

• Cooney JK, Law RJ, Matschke V, Lemmey AB, Moore JP, Ahmad Y, Jones JG, Maddison P, Thom JM. Benefits of exercise in rheumatoid arthritis. J Aging Res. 2011 Feb 13;2011:681640. doi: 10.4061/2011/681640.

  PMID: 21403833 BACKGROUND

• Swardh E, Brodin N. Effects of aerobic and muscle strengthening exercise in adults with rheumatoid arthritis: a narrative review summarising a chapter in Physical activity in the prevention and treatment of disease (FYSS 2016). Br J Sports Med. 2016 Mar;50(6):362-7. doi: 10.1136/bjsports-2015-095793. Epub 2016 Feb 3.

  PMID: 26843536 BACKGROUND

• Sokka T, Hakkinen A, Kautiainen H, Maillefert JF, Toloza S, Mork Hansen T, Calvo-Alen J, Oding R, Liveborn M, Huisman M, Alten R, Pohl C, Cutolo M, Immonen K, Woolf A, Murphy E, Sheehy C, Quirke E, Celik S, Yazici Y, Tlustochowicz W, Kapolka D, Skakic V, Rojkovich B, Muller R, Stropuviene S, Andersone D, Drosos AA, Lazovskis J, Pincus T; QUEST-RA Group. Physical inactivity in patients with rheumatoid arthritis: data from twenty-one countries in a cross-sectional, international study. Arthritis Rheum. 2008 Jan 15;59(1):42-50. doi: 10.1002/art.23255.

  PMID: 18163412 BACKGROUND

• Tierney M, Fraser A, Kennedy N. Physical activity in rheumatoid arthritis: a systematic review. J Phys Act Health. 2012 Sep;9(7):1036-48. doi: 10.1123/jpah.9.7.1036.

  PMID: 22971883 BACKGROUND

• Brodin N, Hurkmans E, DiMatteo L, Nava T, Vliet Vlieland T, Opava CH. Promotion of health-enhancing physical activity in rheumatoid arthritis: a comparative study on healthcare providers in Italy, The Netherlands and Sweden. Rheumatol Int. 2015 Oct;35(10):1665-73. doi: 10.1007/s00296-015-3267-4. Epub 2015 Apr 14.

  PMID: 25869348 BACKGROUND

• Knittle K, De Gucht V, Hurkmans E, Peeters A, Ronday K, Maes S, Vlieland TV. Targeting motivation and self-regulation to increase physical activity among patients with rheumatoid arthritis: a randomised controlled trial. Clin Rheumatol. 2015 Feb;34(2):231-8. doi: 10.1007/s10067-013-2425-x. Epub 2013 Nov 9.

  PMID: 24213780 BACKGROUND

• Larkin L, Gallagher S, Cramp F, Brand C, Fraser A, Kennedy N. Behaviour change interventions to promote physical activity in rheumatoid arthritis: a systematic review. Rheumatol Int. 2015 Oct;35(10):1631-40. doi: 10.1007/s00296-015-3292-3. Epub 2015 May 21.

  PMID: 25994094 BACKGROUND

• Larkin L, Nordgren B, Purtill H, Brand C, Fraser A, Kennedy N. Criterion Validity of the activPAL Activity Monitor for Sedentary and Physical Activity Patterns in People Who Have Rheumatoid Arthritis. Phys Ther. 2016 Jul;96(7):1093-101. doi: 10.2522/ptj.20150281. Epub 2015 Dec 4.

  PMID: 26637646 BACKGROUND

• Larkin L, Gallagher S, Fraser A, Kennedy N. If a joint is hot it's not the time: health professionals' views on developing an intervention to promote physical activity in rheumatoid arthritis. Disabil Rehabil. 2017 Jun;39(11):1106-1113. doi: 10.1080/09638288.2016.1180548. Epub 2016 Jun 8.

  PMID: 27278440 BACKGROUND

• Larkin L, Kennedy N, Fraser A, Gallagher S. 'It might hurt, but still it's good': People with rheumatoid arthritis beliefs and expectations about physical activity interventions. J Health Psychol. 2017 Nov;22(13):1678-1690. doi: 10.1177/1359105316633286. Epub 2016 Mar 8.

  PMID: 26962132 BACKGROUND

• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

  PMID: 21513547 BACKGROUND

• Larkin L, McKenna S, Pyne T, Comerford P, Moses A, Folan A, Gallagher S, Glynn L, Fraser A, Esbensen BA, Kennedy N. Promoting physical activity in rheumatoid arthritis through a physiotherapist led behaviour change-based intervention (PIPPRA): a feasibility randomised trial. Rheumatol Int. 2024 May;44(5):779-793. doi: 10.1007/s00296-024-05544-1. Epub 2024 Mar 4.

  PMID: 38438576 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; 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; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Norelee Kennedy, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre randomised pilot study

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: August 23, 2018
• Study Start: October 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: December 31, 2021
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)