Rheumatoid ArthritisPIPPRANCT03644160
A Physiotherapist Led Intervention to Promote Physical Activity in Rheumatoid Arthritis - a Pilot Study
A study testing Physical activity and behaviour change in people with Rheumatoid Arthritis, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Physical activity and behaviour change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Rheumatoid arthritis
- Age over 18 years
- Classified using Godin-Shephard Leisure-Time Physical Activity Questionnaire as insufficiently active
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Recruitment rate - the rate of participants recruited to the study versus total potential participants
- 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- Physical activity and behaviour change
- Keywords
- Physical activity, Behaviour Change, Physiotherapy
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity and behaviour changeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The rate of participants recruited to the study versus total potential participants
Measured: Baseline
Retention rate
The number of participants who complete baseline measures at week 12
Measured: At week 12
Secondary outcomes (9)
Physical activity - objective
Physical activity profile measured using accelerometry (ActivPal)
Measured: Baseline, 8 and 24-week follow-up
Physical activity - self-report
Self report physical activity (Yale Physical Activity Survey)
Measured: Baseline, 8 and 24-week follow-up
Behaviour Change
Theory of planned behaviour questionnaire (TPBQ)
Measured: Baseline, 8 and 24-week follow-up
Quality of Life in Rheumatoid Arthritis
Quality of Life in Rheumatoid Arthritis (RAQoL) will be used to examine self-reported quality of life in rheumatoid arthritis
Measured: Baseline, 8 and 24-week follow-up
Pain over past 7 days
Visual analogue scale (VAS) will measure self-reported pain levels. 100 mm VAS from 0 (no pain) to 100 (most possible pain).
Measured: Baseline, 8 and 24-week follow-up
Fatigue
Bristol RA Fatigue Multi-dimensional Questionnaire (BRAF-MDQ)
Measured: Baseline, 8 and 24-week follow-up
Function
Health assessment questionnaire (HAQ)
Measured: Baseline, 8 and 24-week follow-up
Sleep
Pittsburgh Sleep Quality Index
Measured: Baseline, 8 and 24-week follow-up
Disease activity profile
The Disease Activity Score 28 (DAS28) combines single measures into an overall, continuous measure of rheumatoid arthritis (RA) disease activity. The DAS28 includes a 28 tender joint count, a 28 swollen joint count, erythrocyte sedimentation rate, and a general health assessment on a visual analog scale.
Measured: Baseline, 8 and 24-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Oct 2019
- Primary completion1 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre randomised pilot study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norelee Kennedy, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644160
- Sponsor's protocol ID
- PIPPRA-1
- Acronym
- PIPPRA
- Status last verified
- Jun 2022
- First submitted
- 1 May 2018
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carmona L, Cross M, Williams B, Lassere M, March L. Rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):733-45. doi: 10.1016/j.berh.2010.10.001.
PubMed 21665122Power 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.
PubMed 10540788Peters 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.
PubMed 19773290Cooney 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.
PubMed 21403833Swardh 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.
PubMed 26843536Sokka 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.
PubMed 18163412Tierney 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.
PubMed 22971883Brodin 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.
PubMed 25869348Knittle 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.
PubMed 24213780Larkin 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.
PubMed 25994094Larkin 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.
PubMed 26637646Larkin 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.
PubMed 27278440Larkin 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.
PubMed 26962132Michie 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.
PubMed 21513547Larkin 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.
PubMed 38438576
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiotherapist Led Intervention to Promote Physical Activity in Rheumatoid Arthritis - a Pilot Study
- ClinicalTrials.gov ID
- NCT03644160
- Acronym / sponsor ID
- PIPPRA / PIPPRA-1
- Conditions
- Rheumatoid Arthritis
- Keywords
- Physical activity, Behaviour Change, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Recruitment rate - the rate of participants recruited to the study versus total potential participants
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre randomised pilot study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Physical activity and behaviour changePhysical 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Rheumatoid arthritis
- Age over 18 years
- Classified using Godin-Shephard Leisure-Time Physical Activity Questionnaire as insufficiently active
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity and behaviour changeThe 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. | Behavioural | Intervention Group |
Primary outcome
Recruitment rate
Time frame: Baseline
The rate of participants recruited to the study versus total potential participants
Retention rate
Time frame: At week 12
The number of participants who complete baseline measures at week 12
9 secondary outcomes
Physical activity - objective
Time frame: Baseline, 8 and 24-week follow-up
Physical activity - self-report
Time frame: Baseline, 8 and 24-week follow-up
Behaviour Change
Time frame: Baseline, 8 and 24-week follow-up
Quality of Life in Rheumatoid Arthritis
Time frame: Baseline, 8 and 24-week follow-up
Pain over past 7 days
Time frame: Baseline, 8 and 24-week follow-up
Fatigue
Time frame: Baseline, 8 and 24-week follow-up
Function
Time frame: Baseline, 8 and 24-week follow-up
Sleep
Time frame: Baseline, 8 and 24-week follow-up
Disease activity profile
Time frame: Baseline, 8 and 24-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Background: PubMed 21665122Carmona L, Cross M, Williams B, Lassere M, March L. Rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):733-45. doi: 10.1016/j.berh.2010.10.001.
- Background: PubMed 10540788Power 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.
- Background: PubMed 19773290Peters 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.
- Background: PubMed 21403833Cooney 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.
- Background: PubMed 26843536Swardh 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.
- Background: PubMed 18163412Sokka 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.
- Background: PubMed 22971883Tierney 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.
- Background: PubMed 25869348Brodin 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.
- Background: PubMed 24213780Knittle 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.
- Background: PubMed 25994094Larkin 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.
- Background: PubMed 26637646Larkin 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.
- Background: PubMed 27278440Larkin 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.
- Individual participant dataSharing planned: No
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Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norelee Kennedy, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and behaviour change in people with Rheumatoid Arthritis, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644160, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.