Clinical trial NCT01966835: Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis
Official title: Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Sleep Disturbances
Keywords: sleep quality
sleep disturbances
high intensity aerobic interval training
rheumatoid arthritis
fatigue
pain
polysomnography
watt max
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Poor sleep quality and sleep disturbances are common in patients with rheumatoid arthritis and are associated with an increased risk of co-morbidity and all-cause mortality.Few studies have examined the possibilities of improving sleep in patients with rheumatoid arthritis, and the focus has primarily been on medical treatment. Aerobic exercise training constitutes a potentially promising, non-pharmacological alternative to improve sleep.

This study is a randomized controlled trial of 44 patients with rheumatoid arthritis.

The aim is to investigate the effect of a moderate-to-high intensity aerobic interval training intervention on sleep quality and sleep disturbances in patients with rheumatoid arthritis.

The primary hypothesis is that moderate-to high intensity aerobic exercise will improve objective measured sleep quality and sleep disturbances. The secondary hypothesis is that the intervention may improve fitness, subjective sleep quality and physical function as well as reduce pain, fatigue, depressive symptoms and improve health-related quality of life.

Detailed description: Poor sleep quality and sleep disturbances are common in patients with rheumatoid arthritis and are associated with an increased risk of co-morbidity, including cardiovascular diseases, diabetes, hypertension, and all-cause mortality. In addition, poor sleep quality is associated with fatigue, pain and physical disability. Few studies have examined the possibilities of improving sleep in patients with rheumatoid arthritis, and the focus has primarily been on medical treatment. Aerobic exercise training constitutes a potentially promising, non-pharmacological alternative to improve sleep in healthy people and patients with insomnia.

The present study is a blinded randomized controlled trial of 44 patients with a diagnosis of rheumatoid arthritis.

The aim is to examine the effect of an aerobic exercise intervention, consisting of 18 exercise sessions, on sleep quality and sleep disturbances in patients with rheumatoid arthritis who experience poor sleep quality.

The primary hypothesis is that moderate to high intensity aerobic exercise will improve objective measured (by polysomnography) sleep quality and sleep disturbances. The secondary hypothesis is that the intervention may improve fitness, subjective sleep quality and physical function as well as reduce pain, fatigue, depressive symptoms and improve health-related quality of life.

The study will provide evidence on the effect of moderate-to-high-intensity aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis. Specifically, the results are expected to provide important evidence about the potential of interval training to improve quality of sleep and sleep disturbances. As such, the study meets a currently unmet need for non-pharmacological treatment initiatives of poor sleep in patients with a systemic inflammatory disorder.

Eligibility criteria: Inclusion Criteria:

* age 18-70 years
* a clinical diagnosis of rheumatoid arthritis
* Experience poor sleep quality (PSQI \>5)
* Low disease activity (DAS28\<3.2)
* Understand Danish

Exclusion Criteria:

* Documented sleep apnea (AHI \>15/hour)
* ECG that does not allow exercise
* Night work during the period in which the intervention takes place
* Pregnant or are breast-feeding
* Treatment with steroid, hypnotics, antidepressants, antipsychotics
* Cardiac symptoms - NYHA \>2
* Regular physically active (aerobic exercise \>3 x per week)

Primary outcomes:
measure: sleep
timeFrame: Change from baseline in objectively measured sleep to 8 weeks
Secondary outcomes:
measure: Cardiopulmonary fitness
timeFrame: change in baseline in VO2-max to 8 weeks
measure: Plasma
timeFrame: change from baseline in plasma to 8 weeks
measure: physiological outcomes
timeFrame: change from baseline in blood pressure, weight and height to 8 weeks
measure: Disease activity
timeFrame: change from baseline in disease activity to 8 weeks
measure: self reported sleep quality and sleep disturbances
timeFrame: change from baseline in selfreported sleep to 8 weeks
measure: self reported sleepiness
timeFrame: change from baseline in sleepiness to 8 weeks
measure: self reported fatigue
timeFrame: change from baseline in fatigue to 8 weeks
measure: self reported depressive symptoms
timeFrame: change from baseline in depressive symptoms to 8 weeks
measure: Physical function
timeFrame: change from baseline in HAQ score to 8 weeks
measure: self reported Health-related quality of life
timeFrame: change from baseline in health related quality of life to 8 weeks
measure: Health and lifestyle questionnaire
timeFrame: change from baseline in health and lifestyle to 8 weeks
measure: Sleep pattern
timeFrame: change from baseline to 8 weeks
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital, Copenhagen University
state: Copenhagen
Study officials:
affiliation: Danish center for sleep medicine, department of clinical neurophysiology, Glostrup Hospital, Copenhagen University, Denmark
name: Poul Jennum, Professor
role: STUDY_DIRECTOR
References:
citation: Loppenthin K, Esbensen BA, Jennum P, Ostergaard M, Christensen JF, Thomsen T, Bech JS, Midtgaard J. Effect of intermittent aerobic exercise on sleep quality and sleep disturbances in patients with rheumatoid arthritis - design of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Feb 21;15:49. doi: 10.1186/1471-2474-15-49.