Rheumatoid ArthritisJRNCT01966835
Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis
A study testing High intensity aerobic interval training in people with Rheumatoid Arthritis and Sleep Disturbances, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis, Sleep Disturbances
- What is being tested?
- High intensity aerobic interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70 years
- a clinical diagnosis of rheumatoid arthritis
- Experience poor sleep quality (PSQI >5)
- Low disease activity (DAS28<3.2)
- Understand Danish
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Katrine Loeppenthin contact
Denmark1 site, 1 recruiting
- Recruiting
Glostrup Hospital, Copenhagen University
Glostrup Municipality, Copenhagen, 2600
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Sleep Disturbances
- Being tested
- High intensity aerobic interval training
- Keywords
- sleep quality, sleep disturbances, high intensity aerobic interval training, rheumatoid arthritis, fatigue, pain, polysomnography, watt max
- Medical subject headings
- Arthritis, Rheumatoid, Parasomnias, Sleep Initiation and Maintenance Disorders, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity aerobic interval trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High intensity aerobic interval training | Experimental | 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. Receives: Behavioral: High intensity aerobic interval training |
| control group | No intervention | no exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep
Measured by polysomnography. Polysomnography is a objective measurement of sleep duration, sleep stages and sleep quality.
Measured: Change from baseline in objectively measured sleep to 8 weeks
Secondary outcomes (12)
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.
Measured: change in baseline in VO2-max to 8 weeks
Plasma
C-reactive protein (CRP) and hemoglobin are assessed
Measured: change from baseline in plasma to 8 weeks
physiological outcomes
Measured: 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
Measured: 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
Measured: change from baseline in selfreported sleep to 8 weeks
self reported sleepiness
The Epworth Sleepiness Scale measures self-reported daytime sleepiness.
Measured: 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
Measured: 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.
Measured: change from baseline in depressive symptoms to 8 weeks
Physical function
The Health Assessment Questionnaire (HAQ) measures self-reported physical function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrine Loeppenthin, Glostrup University Hospital, Copenhagen
- Investigators
- Poul Jennum, Professor, Study director, Danish center for sleep medicine, department of clinical neurophysiology, Glostrup Hospital, Copenhagen University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966835
- Sponsor's protocol ID
- JR sleep
- Acronym
- JR
- Status last verified
- Jul 2014
- First submitted
- 16 Oct 2013
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24559487
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01966835
- Acronym / sponsor ID
- JR / JR sleep
- Conditions
- Rheumatoid Arthritis, Sleep Disturbances
- Keywords
- sleep quality, sleep disturbances, high intensity aerobic interval training, rheumatoid arthritis, fatigue, pain, polysomnography, watt max
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity aerobic interval training | Experimental | Behavioral: High intensity aerobic interval trainingThe 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 intervention | –no exercise intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-70 years
- a clinical diagnosis of rheumatoid arthritis
- Experience poor sleep quality (PSQI >5)
- Low disease activity (DAS28<3.2)
- Understand Danish
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity aerobic interval trainingThe 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. | Behavioural | High intensity aerobic interval training |
Primary outcome
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.
12 secondary outcomes
Cardiopulmonary fitness
Time frame: change in baseline in VO2-max to 8 weeks
Plasma
Time frame: change from baseline in plasma to 8 weeks
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
self reported sleep quality and sleep disturbances
Time frame: change from baseline in selfreported sleep to 8 weeks
self reported sleepiness
Time frame: change from baseline in sleepiness to 8 weeks
self reported fatigue
Time frame: change from baseline in fatigue to 8 weeks
self reported depressive symptoms
Time frame: change from baseline in depressive symptoms to 8 weeks
Physical function
Time frame: change from baseline in HAQ score to 8 weeks
self reported Health-related quality of life
Time frame: change from baseline in health related quality of life to 8 weeks
Health and lifestyle questionnaire
Time frame: change from baseline in health and lifestyle to 8 weeks
Sleep pattern
Time frame: change from baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Derived from this study: PubMed 24559487Loppenthin 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.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrine Loeppenthin contact
Poul Jennum, Professor study director
Danish center for sleep medicine, department of clinical neurophysiology, Glostrup Hospital, Copenhagen University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity aerobic interval training in people with Rheumatoid Arthritis and Sleep Disturbances, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrine Loeppenthin (katrine.bjerre.loeppenthin@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep (time frame: Change from baseline in objectively measured sleep to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01966835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.