Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT01966835
Status:
UNKNOWN
Last Update Posted:
2014-07-18
First Post:
2013-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis
Sponsor:
Glostrup University Hospital, Copenhagen
Organization:
Study Overview
Official Title:
Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis. A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2014-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JR
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.
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: