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Rheumatoid ArthritisNCT03140995

Sleep and Exercise in Rheumatoid Arthritis

A study testing Walking Programme in people with Rheumatoid Arthritis and Inflammatory Arthritis, run by University Hospital of Limerick at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis, Inflammatory Arthritis
What is being tested?
Walking Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteIreland
Study dates
2 Oct 2017to 30 Sep 2018
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • University Hospitals Limerick

    Limerick, Cork

Other trials in Ireland

About this study

Official title: 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.

Read the 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.

Being tested
Walking Programme
Keywords
Exercise, Sleep
Medical subject headings
Arthritis, Rheumatoid, Arthritis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walking ProgrammeBehavioural

    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

Study groups in NCT03140995
Study groupRoleWhat they receive
Exercise InterventionActive 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.
Receives: Behavioral: Walking Programme
Control GroupNo interventionThe control group will be given verbal and written instructions regarding the benefits of exercise in RA.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburgh Sleep Quality Index

    Sleep

    Measured: 8 Weeks

Secondary outcomes (9)

  1. RA related Pain - visual analog scale (VAS) consisting of a 10cm horizontal line anchored from 0 (no pain) to 10 (worst pain possible).

    Pain

    Measured: up to 8 weeks follow up

  2. Profile of Moods State

    Mood

    Measured: up to 8 weeks

  3. Quick Inventory of Depressive Symptomatology

    Depression

    Measured: up to 8 weeks

  4. State Trait Anxiety Inventory

    Anxiety

    Measured: up to 8 weeks

  5. Health Assessment disability Index

    Functional limitation

    Measured: up to 8 weeks

  6. Disease Activity Score with 28 joints

    Disease activity

    Measured: up to 8 weeks

  7. Rheumatoid Arthritis-Specific Quality of Life Instrument

    Quality of Life

    Measured: up to 8 weeks

  8. Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire

    Fatigue

    Measured: up to 8 weeks

  9. Exercise Benefits and Barriers Scale

    Exercise barriers

    Measured: up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2017
  2. Study start2 Oct 2017
  3. Primary completion1 Jun 2018
  4. Study completion30 Sep 2018

Resources

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, 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
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03140995
Sponsor's protocol ID
GOIPG/2016/58
Status last verified
Jul 2019
First submitted
25 Apr 2017
Last updated
8 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 28251248

  • 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.

    PubMed 28573870

  • 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.

    PubMed 29541902

  • 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.

    PubMed 29644891

  • 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.

    PubMed 29766257

  • 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.

    PubMed 33386901

Questions about this trial

What is this clinical trial studying?

A study testing Walking Programme in people with Rheumatoid Arthritis and Inflammatory Arthritis, run by University Hospital 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 1 inclusion and 1 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 8 Jul 2019. 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?

Pittsburgh Sleep Quality Index (time frame: 8 Weeks). 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 NCT03140995, which also lists 6 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 8 Jul 2019.

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Sleep and Exercise in Rheumatoid Arthritis | AzTrials