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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Glostrup University Hospital, Copenhagen
Sponsor:
Information provided by (Responsible Party):
Katrine Loeppenthin, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01966835
First received: October 16, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Sleep Disturbances
Behavioral: High intensity aerobic interval training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • sleep [ Time Frame: Change from baseline in objectively measured sleep to 8 weeks ] [ Designated as safety issue: Yes ]
    Measured by polysomnography. Polysomnography is a objective measurement of sleep duration, sleep stages and sleep quality.


Secondary Outcome Measures:
  • Cardiopulmonary fitness [ Time Frame: change in baseline in VO2-max to 8 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Plasma [ Time Frame: change from baseline in plasma to 8 weeks ] [ Designated as safety issue: No ]
    C-reactive protein (CRP) and hemoglobin are assessed

  • physiological outcomes [ Time Frame: change from baseline in blood pressure, weight and height to 8 weeks ] [ Designated as safety issue: No ]
  • Disease activity [ Time Frame: change from baseline in disease activity to 8 weeks ] [ Designated as safety issue: No ]
    Disease Activity Score (DAS28) is calculated from the number of swollen and tender joints (28 joints), CRP and the patients' global assessment of arthritis

  • self reported sleep quality and sleep disturbances [ Time Frame: change from baseline in selfreported sleep to 8 weeks ] [ Designated as safety issue: No ]
    The Pittsburgh Sleep Quality Index (PSQI) measures self-reported sleep quality and disturbances during the previous four weeks

  • self reported sleepiness [ Time Frame: change from baseline in sleepiness to 8 weeks ] [ Designated as safety issue: No ]
    The Epworth Sleepiness Scale measures self-reported daytime sleepiness.

  • self reported fatigue [ Time Frame: change from baseline in fatigue to 8 weeks ] [ Designated as safety issue: No ]
    The Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF MDQ)measures self-reported fatigue

  • self reported depressive symptoms [ Time Frame: change from baseline in depressive symptoms to 8 weeks ] [ Designated as safety issue: No ]
    The Center for Epidemiological Studies-Depression (CES-D) measures self-reported depressive symptoms.

  • Physical function [ Time Frame: change from baseline in HAQ score to 8 weeks ] [ Designated as safety issue: No ]
    The Health Assessment Questionnaire (HAQ) measures self-reported physical function.

  • self reported Health-related quality of life [ Time Frame: change from baseline in health related quality of life to 8 weeks ] [ Designated as safety issue: No ]
    EuroQol (EQ-5D-5L)measures health-related quality of life.

  • Health and lifestyle questionnaire [ Time Frame: change from baseline in health and lifestyle to 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Sleep pattern [ Time Frame: change from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 44
Study Start Date: May 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966835

Contacts
Contact: Katrine Loeppenthin katrine.bjerre.loeppenthin@regionh.dk

Locations
Denmark
Glostrup Hospital, Copenhagen University Recruiting
Glostrup, Copenhagen, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Study Director: Poul Jennum, Professor Danish center for sleep medicine, department of clinical neurophysiology, Glostrup Hospital, Copenhagen University, Denmark
  More Information

No publications provided by Glostrup University Hospital, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katrine Loeppenthin, PhD student, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01966835     History of Changes
Other Study ID Numbers: JR sleep
Study First Received: October 16, 2013
Last Updated: July 17, 2014
Health Authority: Denmark: National Board of Health

Keywords provided by Glostrup University Hospital, Copenhagen:
sleep quality
sleep disturbances
high intensity aerobic interval training
rheumatoid arthritis
fatigue
pain
polysomnography
watt max

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Sleep Disorders
Dyssomnias
Parasomnias
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014