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

Rheumatoid Arthritis Clinical Trial

— JR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01966835
• Other study ID #: JR sleep
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2013
• Last updated: July 17, 2014
• Start date: May 2013

Study information

• Verified date: July 2014
• Source: Glostrup University Hospital, Copenhagen
• Contact: Katrine Loeppenthin
• Email: katrine.bjerre.loeppenthin[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Dyssomnias
• Parasomnias
• Rheumatoid Arthritis
• Sleep Disorders
• Sleep Disturbances

Intervention

Behavioral:
• High intensity aerobic interval training
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.

Locations

Country	Name	City	State
Denmark	Glostrup Hospital, Copenhagen University	Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Plasma	C-reactive protein (CRP) and hemoglobin are assessed	change from baseline in plasma to 8 weeks	No
Secondary	physiological outcomes		change from baseline in blood pressure, weight and height to 8 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	self reported sleepiness	The Epworth Sleepiness Scale measures self-reported daytime sleepiness.	change from baseline in sleepiness to 8 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Physical function	The Health Assessment Questionnaire (HAQ) measures self-reported physical function.	change from baseline in HAQ score to 8 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No