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

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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Sleep Disturbances
• Intervention / Treatment: Behavioral: High intensity aerobic interval training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Glostrup, Copenhagen, Denmark, 2600
      • Recruiting
      • Glostrup Hospital, Copenhagen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: control group; no exercise intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Investigators: Study Director: Poul Jennum, Professor, Danish center for sleep medicine, department of clinical neurophysiology, Glostrup Hospital, Copenhagen University, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 22, 2013

Study Record Updates

• Last Update Posted (Estimate): July 18, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; polysomnography; pain; fatigue; sleep disturbances; sleep quality; high intensity aerobic interval training; watt max
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Sleep Wake Disorders; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Dyssomnias; Parasomnias
• Other Study ID Numbers: JR sleep