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Sleep and Exercise in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis, Inflammatory Arthritis

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Walking Programme
Sponsored by
University Hospital of Limerick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Exercise, Sleep

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • University Hospitals Limerick

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Exercise Intervention

Control Group

Arm Description

The 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.

The control group will be given verbal and written instructions regarding the benefits of exercise in RA.

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Quality Index
Sleep

Secondary Outcome Measures

RA related Pain - visual analog scale (VAS) consisting of a 10cm horizontal line anchored from 0 (no pain) to 10 (worst pain possible).
Pain
Profile of Moods State
Mood
Quick Inventory of Depressive Symptomatology
Depression
State Trait Anxiety Inventory
Anxiety
Health Assessment disability Index
Functional limitation
Disease Activity Score with 28 joints
Disease activity
Rheumatoid Arthritis-Specific Quality of Life Instrument
Quality of Life
Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
Fatigue
Exercise Benefits and Barriers Scale
Exercise barriers

Full Information

First Posted
April 25, 2017
Last Updated
July 4, 2019
Sponsor
University Hospital of Limerick
Collaborators
University of Limerick
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1. Study Identification

Unique Protocol Identification Number
NCT03140995
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Limerick
Collaborators
University of Limerick

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Inflammatory Arthritis
Keywords
Exercise, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention
Arm Type
Active Comparator
Arm Description
The 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will be given verbal and written instructions regarding the benefits of exercise in RA.
Intervention Type
Behavioral
Intervention Name(s)
Walking Programme
Intervention Description
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
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
Sleep
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
RA related Pain - visual analog scale (VAS) consisting of a 10cm horizontal line anchored from 0 (no pain) to 10 (worst pain possible).
Description
Pain
Time Frame
up to 8 weeks follow up
Title
Profile of Moods State
Description
Mood
Time Frame
up to 8 weeks
Title
Quick Inventory of Depressive Symptomatology
Description
Depression
Time Frame
up to 8 weeks
Title
State Trait Anxiety Inventory
Description
Anxiety
Time Frame
up to 8 weeks
Title
Health Assessment disability Index
Description
Functional limitation
Time Frame
up to 8 weeks
Title
Disease Activity Score with 28 joints
Description
Disease activity
Time Frame
up to 8 weeks
Title
Rheumatoid Arthritis-Specific Quality of Life Instrument
Description
Quality of Life
Time Frame
up to 8 weeks
Title
Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
Description
Fatigue
Time Frame
up to 8 weeks
Title
Exercise Benefits and Barriers Scale
Description
Exercise barriers
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Facility Information:
Facility Name
University Hospitals Limerick
City
Limerick
State/Province
Cork
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Early 2020
Citations:
PubMed Identifier
28251248
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.
Results Reference
result
PubMed Identifier
28573870
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.
Results Reference
result
PubMed Identifier
29541902
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. Erratum In: Rheumatol Int. 2018 Nov;38(11):2165.
Results Reference
result
PubMed Identifier
29644891
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.
Results Reference
result
PubMed Identifier
29766257
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.
Results Reference
result
PubMed Identifier
33386901
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.
Results Reference
derived
Links:
URL
https://link.springer.com/article/10.1007/s00296-018-4052-y
Description
The impact of exercise on sleep (time, quality, and disturbance) in patients with rheumatoid arthritis: a study protocol for a pilot randomised controlled trial

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Sleep and Exercise in Rheumatoid Arthritis

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