Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis
JR
1 other identifier
interventional
44
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 16, 2013
CompletedFirst Posted
Study publicly available on registry
October 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedJuly 18, 2014
July 1, 2014
1.6 years
October 16, 2013
July 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Cardiopulmonary fitness
change in baseline in VO2-max to 8 weeks
Plasma
change from baseline in plasma to 8 weeks
physiological outcomes
change from baseline in blood pressure, weight and height to 8 weeks
Disease activity
change from baseline in disease activity to 8 weeks
self reported sleep quality and sleep disturbances
change from baseline in selfreported sleep to 8 weeks
- +7 more secondary outcomes
Study Arms (2)
High intensity aerobic interval training
EXPERIMENTALThe 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.
control group
NO INTERVENTIONno exercise intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- age 18-70 years
- a clinical diagnosis of rheumatoid arthritis
- Experience poor sleep quality (PSQI \>5)
- Low disease activity (DAS28\<3.2)
- Understand Danish
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glostrup Hospital, Copenhagen University
Glostrup Municipality, Copenhagen, 2600, Denmark
Related Publications (1)
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.
PMID: 24559487DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Poul Jennum, Professor
Danish center for sleep medicine, department of clinical neurophysiology, Glostrup Hospital, Copenhagen University, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
October 16, 2013
First Posted
October 22, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2014
Last Updated
July 18, 2014
Record last verified: 2014-07