Clinical trial NCT03140995: Sleep and Exercise in Rheumatoid Arthritis
Official title: Does Exercise Have an Impact on Sleep and Mood in People Who Have Rheumatoid Arthritis: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Inflammatory Arthritis
Keywords: Exercise
Sleep
Lead sponsor: University Hospital of Limerick
Sponsor class: OTHER
Collaborators: name: University of Limerick
First posted: 2017-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre, single blinded pilot randomised controlled trial, comparing an aerobic intermittent exercise training intervention (walking programme) against verbal and written instructions regarding the benefits of exercise in RA.
Primary purpose: TREATMENT

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.

Detailed description: Sleep is an important aspect in maintaining the body's circadian rhythm. In general getting fewer than 5 hours sleep per day has been associated with cardiovascular problems, diabetes and obesity and can also be linked to depression and anxiety. Poor sleep is a common complaint among people with rheumatoid arthritis (RA) with disturbed sleep and fatigue known to affect up to 70% in this population. Poor sleep quality may contribute to the feelings of pain, fatigue and poor psychological well-being which in turn may further deteriorate functional ability and reduced activity.

It is known that exercise improves a person's psychological state which can also be an additional factor in improving or indeed disrupting quality of sleep. Exercise has been identified as an important part of the nonpharmacological management of poor sleep and in improving sleep quality however, people with RA were previously cautioned about undertaking exercise. Therefore, changes in sleep quality during exercise intervention should be evaluated so that society can understand more the potential for long-term changes in overall health status, in people who have RA. Indeed the intensity level of the activity in people with RA may be of additional importance.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 Weeks
Secondary outcomes:
measure: RA related Pain - visual analog scale (VAS) consisting of a 10cm horizontal line anchored from 0 (no pain) to 10 (worst pain possible).
timeFrame: up to 8 weeks follow up
measure: Profile of Moods State
timeFrame: up to 8 weeks
measure: Quick Inventory of Depressive Symptomatology
timeFrame: up to 8 weeks
measure: State Trait Anxiety Inventory
timeFrame: up to 8 weeks
measure: Health Assessment disability Index
timeFrame: up to 8 weeks
measure: Disease Activity Score with 28 joints
timeFrame: up to 8 weeks
measure: Rheumatoid Arthritis-Specific Quality of Life Instrument
timeFrame: up to 8 weeks
measure: Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
timeFrame: up to 8 weeks
measure: Exercise Benefits and Barriers Scale
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University Hospitals Limerick
state: Cork
Study officials:
References:
citation: 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.
citation: McKenna 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.
citation: McKenna 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.
citation: McKenna 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.
citation: McKenna 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.
citation: McKenna 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.