Sleep and Exercise in Rheumatoid Arthritis

July 4, 2019 updated by: Sean McKenna, University Hospital of Limerick

Does Exercise Have an Impact on Sleep and Mood in People Who Have Rheumatoid Arthritis: a Pilot Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Cork
      • Limerick, Cork, Ireland
        • University Hospitals Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise Intervention
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.
Behavioral: Walking Programme
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
No Intervention: Control Group
The control group will be given verbal and written instructions regarding the benefits of exercise in RA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index
Time Frame: 8 Weeks
Sleep
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RA related Pain - visual analog scale (VAS) consisting of a 10cm horizontal line anchored from 0 (no pain) to 10 (worst pain possible).
Time Frame: up to 8 weeks follow up
Pain
up to 8 weeks follow up
Profile of Moods State
Time Frame: up to 8 weeks
Mood
up to 8 weeks
Quick Inventory of Depressive Symptomatology
Time Frame: up to 8 weeks
Depression
up to 8 weeks
State Trait Anxiety Inventory
Time Frame: up to 8 weeks
Anxiety
up to 8 weeks
Health Assessment disability Index
Time Frame: up to 8 weeks
Functional limitation
up to 8 weeks
Disease Activity Score with 28 joints
Time Frame: up to 8 weeks
Disease activity
up to 8 weeks
Rheumatoid Arthritis-Specific Quality of Life Instrument
Time Frame: up to 8 weeks
Quality of Life
up to 8 weeks
Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
Time Frame: up to 8 weeks
Fatigue
up to 8 weeks
Exercise Benefits and Barriers Scale
Time Frame: up to 8 weeks
Exercise barriers
up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Limerick

Collaborators

University of Limerick

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOIPG/2016/58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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