Sleep and Exercise in Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis Inflammatory Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Walking Programme

Intervention Type BEHAVIORAL

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes