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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Katrine Loeppenthin, Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01966835
First Posted: October 22, 2013
Last Update Posted: July 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Katrine Loeppenthin, Glostrup University Hospital, Copenhagen
  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 (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 Katrine Loeppenthin, Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • sleep [ Time Frame: Change from baseline in objectively measured sleep to 8 weeks ]
    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 ]
    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 ]
    C-reactive protein (CRP) and hemoglobin are assessed

  • physiological outcomes [ Time Frame: change from baseline in blood pressure, weight and height to 8 weeks ]
  • Disease activity [ Time Frame: change from baseline in disease activity to 8 weeks ]
    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 ]
    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 ]
    The Epworth Sleepiness Scale measures self-reported daytime sleepiness.

  • self reported fatigue [ Time Frame: change from baseline in fatigue to 8 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 16, 2013
First Posted: October 22, 2013
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by Katrine Loeppenthin, 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
Dyssomnias
Sleep Wake Disorders
Parasomnias
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms