Sleep and Exercise in Rheumatoid Arthritis
Does Exercise Have an Impact on Sleep and Mood in People Who Have Rheumatoid Arthritis: a Pilot Randomised Controlled Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
Regular physical activity is important for people with rheumatoid arthritis (RA). Sleep requirements for adults should be on a 'sleep needs spectrum' of between 7 to 9 hours per day. Poor sleep is a common complaint among people with RA, which may have an effect on their activity levels and well-being. There is evidence that physical activity and exercise can improve sleep quality and disturbances in other chronic disease populations therefore, examining how same affects sleep in RA is important.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable rheumatoid-arthritis
Started Oct 2017
Shorter than P25 for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedStudy Start
First participant enrolled
October 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedJuly 8, 2019
July 1, 2019
8 months
April 25, 2017
July 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pittsburgh Sleep Quality Index
Sleep
8 Weeks
Secondary Outcomes (9)
RA related Pain - visual analog scale (VAS) consisting of a 10cm horizontal line anchored from 0 (no pain) to 10 (worst pain possible).
up to 8 weeks follow up
Profile of Moods State
up to 8 weeks
Quick Inventory of Depressive Symptomatology
up to 8 weeks
State Trait Anxiety Inventory
up to 8 weeks
Health Assessment disability Index
up to 8 weeks
- +4 more secondary outcomes
Study Arms (2)
Exercise Intervention
ACTIVE COMPARATORThe walking programme will consist of a total of 21 aerobic walking sessions, with 1 per week being supervised by a trained physiotherapist, spread over a maximum of eight weeks (2-3 times/week). During the first 4 weeks the intention is to increase frequency and the final 4 weeks the intensity, using the Borg Rate of Perceived exertion 6-20 or distance from 2km to 6km. The participants will attend the University of Limerick for a final assessment at week 9.
Control Group
NO INTERVENTIONThe control group will be given verbal and written instructions regarding the benefits of exercise in RA.
Interventions
The programme will be devised using incremental targets for daily walks based on the 6-20 Borg of rating of perceived exertion scale (Borg RPE). They will be instructed that they should be moderately short of breath on exertion i.e. unable to comfortably hold a conversation while walking
Eligibility Criteria
You may qualify if:
- Participants will be eligible to participate if they are aged 18-70; have a diagnosis of RA (defined by the American College of Rheumatology 1987 criteria); have poor sleep (Pittsburgh Sleep Quality Index global score \>5); have a low disease score on 28 joints (DAS28) \<3.2; Health Assessment Questionnaire result of \<2.4 and are able to provided informed consent, understand and speak English. All the above will be determined should the person be interested in participating and before any fitness testing will be place.
You may not qualify if:
- Participants will be excluded from the study if they have severe physical disability (HAQ score \> 2.5); are pregnant; participate in regular physical activity in their leisure time (self-reported aerobic exercise \> 5 times per week); have cardiac symptoms corresponding to New York Heart Association (NYHA) functional classification \> 2;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital of Limericklead
- University of Limerickcollaborator
Study Sites (1)
University Hospitals Limerick
Limerick, Cork, Ireland
Related Publications (6)
McKenna S, Donnelly A, Fraser A, Comber L, Kennedy N. Does exercise impact on sleep for people who have rheumatoid arthritis? A systematic review. Rheumatol Int. 2017 Jun;37(6):963-974. doi: 10.1007/s00296-017-3681-x. Epub 2017 Mar 1.
PMID: 28251248RESULTMcKenna S, Donnelly A, Fraser A, Kennedy N. Sleep and physical activity: a survey of people with inflammatory arthritis and their engagement by health professionals in rheumatology in Ireland. Disabil Rehabil. 2018 Sep;40(19):2260-2266. doi: 10.1080/09638288.2017.1334095. Epub 2017 Jun 2.
PMID: 28573870RESULTMcKenna S, Tierney M, O'Neill A, Fraser A, Kennedy N. Sleep and physical activity: a cross-sectional objective profile of people with rheumatoid arthritis. Rheumatol Int. 2018 May;38(5):845-853. doi: 10.1007/s00296-018-4009-1. Epub 2018 Mar 14.
PMID: 29541902RESULTMcKenna S, Kelly G, Kennedy N. A survey of physiotherapists' current management and the promotion of physical activity, in people with rheumatoid arthritis. Disabil Rehabil. 2019 Sep;41(18):2183-2191. doi: 10.1080/09638288.2018.1461258. Epub 2018 Apr 12.
PMID: 29644891RESULTMcKenna SG, Donnelly AE, Esbensen BA, Fraser AD, Kennedy NM. The impact of exercise on sleep (time, quality, and disturbance) in patients with rheumatoid arthritis: a study protocol for a pilot randomised controlled trial. Rheumatol Int. 2018 Jul;38(7):1191-1198. doi: 10.1007/s00296-018-4052-y. Epub 2018 May 15.
PMID: 29766257RESULTMcKenna SG, Donnelly A, Esbensen BA, Comber L, Ng WL, Anjum AM, Fraser A, Kennedy NM. The feasibility of an exercise intervention to improve sleep (time, quality and disturbance) in people with rheumatoid arthritis: a pilot RCT. Rheumatol Int. 2021 Feb;41(2):297-310. doi: 10.1007/s00296-020-04760-9. Epub 2021 Jan 2.
PMID: 33386901DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- At baseline assessment demographic information and outcome measures will be collected by a physiotherapist not involved in the intervention and will be blinded to which arm the participant has been allocated to. This will all take place at the Department of Clinical Therapies, University of Limerick.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Candidate
Study Record Dates
First Submitted
April 25, 2017
First Posted
May 4, 2017
Study Start
October 2, 2017
Primary Completion
June 1, 2018
Study Completion
September 30, 2018
Last Updated
July 8, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Early 2020
The investigating team only will have access to the patient's names and/or identifying factors for participants at the site and University of Limerick (UL) researchers will have access to the full data set from the single site. Participants will be allocated a study code. Thereafter It is anticipated that the results will be used in presentations to conferences such as European League against Rheumatism (EULAR) and American College of Rheumatology (ACR). Additionally papers will be prepared for submission to peer reviewed journals, through Arthritis Ireland and the UL Research office. Results will also be made available at aggregate level to Consultant Rheumatologists Dr. Alexander Fraser and Dr. Joe Devlin, Department of Rheumatology, University Hospitals Limerick. Results will be shared via supplementary material thereafter.