Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis. A Randomized Controlled Trial

Conditions
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Rheumatoid Arthritis, Sleep Disturbances

Intervention / Treatment
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* Behavioral: High intensity aerobic interval training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity aerobic interval training<br>The intervention consists of a total of 18 moderate-to-high intensity aerobic interval training sessions (20-30 minutes/session) spread over a maximum of eight weeks (2-3 times/week) as shown in Table 1. The training sessions are performed on bicycle ergometers (Kettler) and supervised by physiotherapists. Each session is built up by brief periods of high-intensity aerobic exercise (70-80 %) separated by recovery periods of lower-intensity (40-50%). Each session is introduced by a 5-minute warm-up and ends with a 5-minute cool-down (equivalent to 40-50% watt max). The absolute exercise intensity/workload (watt) is determined individually for each participant based on the watt max test performed at baseline. | Behavioral: High intensity aerobic interval training<br>* The intervention consists of a total of 18 moderate-to-high intensity aerobic interval training sessions (20-30 minutes/session) spread over a maximum of eight weeks (2-3 times/week) as shown in Table 1. The training sessions are performed on bicycle ergometers (Kettler) and supervised by physiotherapists. Each session is built up by brief periods of high-intensity aerobic exercise (70-80 %) separated by recovery periods of lower-intensity (40-50%). Each session is introduced by a 5-minute warm-up and ends with a 5-minute cool-down (equivalent to 40-50% watt max). The absolute exercise intensity/workload (watt) is determined individually for each participant based on the watt max test performed at baseline.<br>|
| No Intervention: control group<br>no exercise intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep | Measured by polysomnography. Polysomnography is a objective measurement of sleep duration, sleep stages and sleep quality. | Change from baseline in objectively measured sleep to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary fitness | The patients' aerobic capacity is assessed by an incremental maximum work test on bicycle ergometer. Following a 5-minute warm-up period on individual steady state work intensity, the work load increases by 20 watt each minute until exhaustion. | change in baseline in VO2-max to 8 weeks | 
| Plasma | C-reactive protein (CRP) and hemoglobin are assessed | change from baseline in plasma to 8 weeks | 
| physiological outcomes |  | change from baseline in blood pressure, weight and height to 8 weeks | 
| Disease activity | Disease Activity Score (DAS28) is calculated from the number of swollen and tender joints (28 joints), CRP and the patients' global assessment of arthritis | change from baseline in disease activity to 8 weeks | 
| self reported sleep quality and sleep disturbances | The Pittsburgh Sleep Quality Index (PSQI) measures self-reported sleep quality and disturbances during the previous four weeks | change from baseline in selfreported sleep to 8 weeks | 
| self reported sleepiness | The Epworth Sleepiness Scale measures self-reported daytime sleepiness. | change from baseline in sleepiness to 8 weeks | 
| self reported fatigue | The Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF MDQ)measures self-reported fatigue | change from baseline in fatigue to 8 weeks | 
| self reported depressive symptoms | The Center for Epidemiological Studies-Depression (CES-D) measures self-reported depressive symptoms. | change from baseline in depressive symptoms to 8 weeks | 
| Physical function | The Health Assessment Questionnaire (HAQ) measures self-reported physical function. | change from baseline in HAQ score to 8 weeks | 
| self reported Health-related quality of life | EuroQol (EQ-5D-5L)measures health-related quality of life. | change from baseline in health related quality of life to 8 weeks | 
| Health and lifestyle questionnaire | Information about self-reported comorbidity, age, gender, education, work, income, physical activity, smoking, alcohol and caffeinated drinks per day will be recorded. Patients are also asked of information about actual medical treatment. | change from baseline in health and lifestyle to 8 weeks | 
| Sleep pattern | Patients complete sleep diaries for 14 days after each polysomnography measurement in order to closely and prospectively monitor and describe potential changes in their sleep. | change from baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, sleep quality, sleep disturbances, high intensity aerobic interval training, rheumatoid arthritis, pain, polysomnography, watt max