AzTrials
AzTrials

DepressionEASEDNCT03673397

The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression

A study testing Aerobic exercise, bicycle ergometer in people with Depression and Sleep, run by Oberwaid AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this trial is to investigate the effects of a single bout of aerobic exercise on sleep in patients with depression. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression, Sleep, Sleep Disorder
What is being tested?
Aerobic exercise, bicycle ergometer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteSwitzerland
Study dates
24 Sep 2018to 6 Jan 2020
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inpatient psychosomatic rehabilitation in the clinic OBERWAID, St.Gallen, Switzerland
  • Age: ≥18 and ≤65 years old
  • Primary diagnosis of depression (F32, F33) without psychotic episode according to International Statistical Classification of Diseases, 10th edition

Who cannot join

  • Regular use of hypnotic agents (patients were included if no hypnotic agents were taken 2 weeks prior to study participation)
  • Factors precluding exercise testing or training
  • Use of beta-blockers (with the exception of Carvedilol \& Nebivolol)
  • Use of opioids
  • History of epilepsy
  • Restless legs syndrome defined by ≥7 points on the restless legs syndrome screening questionnaire (RLSSQ)
  • Moderate or severe sleep apnea defined by an oxygen desaturation index (ODI) ≥15 in the first polysomnography.
  • Morbid adiposity with BMI >40

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Oberwaid Ag

    Sankt Gallen, 9016

Other trials in Switzerland

About this study

Official title: The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression: a Randomized Controlled Trial

The aim of this trial is to investigate the effects of a single bout of aerobic exercise on sleep in patients with depression.

Read the detailed description

PRIMARY OBJECTIVE:

The primary objective of this study is to evaluate whether a single bout of aerobic exercise improves sleep efficiency more than a control condition in patients with depression.

SECONDARY OBJECTIVES:

Secondary objectives are to assess the effects of a single bout of aerobic exercise on 1) sleep continuity, 2) sleep architecture, 3) pre-sleep arousal, 4) subjective sleep quality, 5) daytime sleepiness, 6) nocturnal blood pressure, 7) heart rate variability, and 8) the frequency and severity of adverse events.

DESIGN:

This will be a two-arm parallel group, randomized, outcome assessor blinded, controlled, superiority trial. According to sample size calculation a total of 92 patients will be randomized using minimization. The trial will take place in the first five days of the patients' psychosomatic in-patient rehabilitation in the clinic OBERWAID, St.Gallen, Switzerland. The study visits are scheduled is as follows:

Day 0-2: Screening, inclusion, and graded exercise test to determine exercise intensity of intervention

Day 3: Questionnaires for background information

Night 1 (day 3-4): Baseline polysomnography and sleep related questionnaires

Day 4: Randomized allocation (control or exercise condition) and performing corresponding intervention

Night 2 (day 4-5): Follow-up polysomnography and sleep related questionnaires

Day 5: Daytime sleepiness questionnaire

Being tested
Aerobic exercise, bicycle ergometer
Keywords
Exercise, Sleep, Depression, Heart rate variability, Blood pressure, randomized controlled trial, polysomnography
Medical subject headings
Depression, Sleep Wake Disorders, Parasomnias, Sleep Deprivation, Sleep Initiation and Maintenance Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exercise, bicycle ergometerBehavioural

    Exercise performed below individual anaerobic threshold for 30 minutes

Study groups in NCT03673397
Study groupRoleWhat they receive
Aerobic exerciseExperimentalPatients allocated to the intervention group will perform a single bout of supervised aerobic exercise. The starting time will be approximately 1630 hrs. The exercise mode will be a bicycle ergometer. After a warm-up period, during which the intensity is gradually increased, an intensity of 80% of the individual anaerobic threshold will be maintained for 30 minutes. The intensity level was chosen based on clinical experience that this corresponds to an approximate rate of perceived exertion of 13 (on a scale from 6-20) in this population.
Receives: Behavioral: Aerobic exercise, bicycle ergometer
ControlNo interventionIndividuals allocated to the control group will be placed in a room with analogous conditions to the exercise group concerning light, temperature and absence of music at the same time as individuals performing the exercise intervention. The control group will be asked to remain seated and read magazines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in sleep efficiency (%) at follow-up assessed by polysomnography

    Calculated as (total sleep time / total recording time) * 100. Higher values represent a better outcome. A one-way ANCOVA will be computed with baseline sleep efficiency (%) and minimization factors as covariates, intervention as the independent variable, and follow-up sleep efficiency (%) as the dependent variable.

    Measured: Baseline (night 1) and follow-up (night 2)

Secondary outcomes (19)
  1. Change from baseline in wake after sleep onset (minutes) at follow-up assessed by polysomnography

    Calculated as time awake after first sleep episode. Lower values represent better outcome. A one-way ANCOVA will be computed with baseline wake after sleep onset and minimization factors as covariates, intervention as the independent variable, and follow-up wake after sleep onset as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  2. Change from baseline in sleep onset latency (minutes) at follow-up assessed by polysomnography

    Calculated as time between lights-off marker and first epoch of any sleep stage. Lower values represent better outcome. A one-way ANCOVA will be computed with baseline sleep onset latency and minimization factors as covariates, intervention as the independent variable, and follow-up sleep onset latency as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  3. Change from baseline in number of awakenings at follow-up assessed by polysomnography

    Calculated as number of wake periods of at least two epochs after sleep onset. Lower values represent better outcome. A one-way ANCOVA will be computed with baseline number of awakenings and minimization factors as covariates, intervention as the independent variable, and follow-up number of awakenings as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  4. Change from baseline in stage 1 sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography

    Calculated as Stage 1 sleep (in minutes and % of total sleep time). A one-way ANCOVA will be computed with baseline stage 1 sleep (% of total sleep time and minutes) and minimization factors as covariates, intervention as the independent variable, and follow-up stage 1 sleep (% of total sleep time and minutes) as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  5. Change from baseline in stage 2 sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography

    Calculated as Stage 2 sleep (in minutes and % of total sleep time). A one-way ANCOVA will be computed with baseline stage 2 sleep (% of total sleep time and minutes) and minimization factors as covariates, intervention as the independent variable, and follow-up stage 2 sleep (% of total sleep time and minutes) as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  6. Change from baseline in stage 3 sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography

    Calculated as Stage 3 sleep (in minutes and % of total sleep time). A one-way ANCOVA will be computed with baseline stage 3 sleep (% of total sleep time and minutes) and minimization factors as covariates, intervention as the independent variable, and follow-up stage 3 sleep (% of total sleep time and minutes) as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  7. Change from baseline in rapid eye movement sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography

    Calculated as rapid eye movement sleep (in minutes and % of total sleep time). A one-way ANCOVA will be computed with baseline rapid eye movement sleep (% of total sleep time and minutes) and minimization factors as covariates, intervention as the independent variable, and follow-up rapid eye movement sleep (% of total sleep time and minutes) as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  8. Change from baseline in light sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography

    Calculated as sum of Stage 1 \& 2 sleep (in minutes and % of total sleep time). A one-way ANCOVA will be computed with baseline light sleep (% of total sleep time and minutes) and minimization factors as covariates, intervention as the independent variable, and follow-up light sleep (% of total sleep time and minutes) as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  9. Change from baseline in non-rapid eye movement sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography

    Calculated as sum of Stage 1, 2 and 3 sleep (in minutes and % of total sleep time). A one-way ANCOVA will be computed with baseline non-rapid eye movement sleep (in minutes and % of total sleep time) and minimization factors as covariates, intervention as the independent variable, and follow-up non-rapid eye movement sleep (in minutes and % of total sleep time) as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  10. Change from baseline in rapid eye movement sleep-latency (minutes) at follow-up assessed by polysomnography

    Calculated as time between sleep onset and the occurrence of the first REM sleep epoch (minutes). A one-way ANCOVA will be computed with baseline rapid eye movement sleep-latency (minutes) and minimization factors as covariates, intervention as the independent variable, and follow-up rapid eye movement sleep-latency (minutes) as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  11. Change from baseline in stage shift index at follow-up assessed by polysomnography

    Calculated as the number of transitions between any wake or sleep stage divided by hours of total sleep time. Lower values represent better outcome. A one-way ANCOVA will be computed with baseline stage shift index and minimization factors as covariates, intervention as the independent variable, and follow-up stage shift index as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  12. Change from baseline in subjective sleep quality at follow-up assessed by self-rated questionnaire 'revised Schlaffragebogen A'

    Five factors are calculated from 'revised Schlaffragebogen A': sleep quality, recuperation after sleep, calmness prior to sleep, exhaustion prior to sleep, and psychosomatic symptoms during sleep. Values range from 1 to 5. Higher values indicate better outcome in the first three subscales. Lower values indicate better outcome in the last two subscales. A one-way ANCOVA will be computed with baseline values and minimization factors as covariates, intervention as the independent variable, and follow-up value as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  13. Change from baseline in subjective pre-sleep arousal at follow-up assessed by self-rated questionnaire 'Pre-Sleep Arousal Scale'

    Two factors are calculated from 'Pre-Sleep Arousal Scale': cognitive arousal (range: 7-35) and somatic arousal (range: 8-40). Lower values indicate better outcome in both scales. A one-way ANCOVA will be computed with baseline values and minimization factors as covariates, intervention as the independent variable, and follow-up value as dependent variables.

    Measured: Baseline (night 1) and follow-up (night 2)

  14. Change from baseline in pre-sleep autonomic modulation at follow-up

    Assessed through short-term (5 minutes as of lights off) heart rate variability measured by ECG (modified lead II). Heart rate variability will be assessed by time-domain (Root Mean Square of successive differences of normal-to-normal intervals (RMSSD) and standard deviation of normal-to-normal intervals (SDNN)) as well as frequency domain (total power (TP), low frequency power (LF), high frequency power (HF), and ratio of LF-to-HF power (LF/HF)). A one-way ANCOVA will be computed with baseline heart rate variability indices and minimization factors as covariates, intervention as the independent variable, and follow-up heart rate variability indices as the dependent variable.

    Measured: Baseline (night 1) and follow-up (night 2)

  15. Change from baseline in nocturnal autonomic modulation at follow up

    Assessed by heart rate variability through a 6-hour period as of sleep onset, measured by ECG (modified lead II). Heart rate variability will be assessed by time-domain (Root Mean Square of successive differences of normal-to-normal intervals (RMSSD) and standard deviation of normal-to-normal intervals (SDNN)) as well as frequency domain (total power (TP), low frequency power (LF), high frequency power (HF), and ratio of LF-to-HF power (LF/HF)). The 6-hour period is split into six hourly segments for analysis. Hourly segments of nocturnal HRV will be analyzed using a linear mixed model with subject as random effect, adjusting for baseline and minimization factors.

    Measured: Baseline (night 1) and follow-up (night 2)

  16. Change from baseline in post-sleep autonomic modulation at follow-up

    Assessed through short-term (5 minutes as of last awakening) heart rate variability measured by ECG (modified lead II). Heart rate variability will be assessed by time-domain (Root Mean Square of successive differences of normal-to-normal intervals (RMSSD) and standard deviation of normal-to-normal intervals (SDNN)) as well as frequency domain (total power (TP), low frequency power (LF), high frequency power (HF), and ratio of LF-to-HF power (LF/HF)). A one-way ANCOVA will be computed with baseline heart rate variability indices and minimization factors as covariates, intervention as the independent variable, and follow-up heart rate variability indices as the dependent variable.

    Measured: Baseline (night 1) and follow-up (night 2)

  17. Change from baseline in nocturnal mean arterial pressure at follow-up assessed by pulse transit time (ECG, modified lead II; fingertip photoplethysmogram, single initial calibration measurement)

    Mean arterial pressure is calculated from systolic and diastolic blood pressures as follows: [(0.33 * systolic pressure) + (0.66 * diastolic pressure)]. Mean arterial pressure will be reported separately for total sleep time, non-rapid eye movement sleep, and rapid eye movement sleep. A one-way ANCOVA will be computed with baseline mean arterial pressure and minimization factors as covariates, intervention as the independent variable, and follow-up mean arterial pressure as the dependent variable.

    Measured: Baseline (night 1) and follow-up (night 2)

  18. State sleepiness assessed by self-rated questionnaire 'Stanford Sleepiness Scale' (SSS)

    This is a single item questionnaire on a 7-point scale (1-7). Higher values indicate worse outcome.

    Measured: Day 5 (i.e. day after night 2): at 08:00 am, 12 noon, 04:00 pm, and 08:00 pm

  19. Difference in adverse events between exercise and control group

    Adverse events will be explicitly assessed through a questionnaire. Patients will be asked whether they experienced adverse effects on a five point Likert scale (not at all, very) using the following categories: Pain (if yes, location), dizziness, cardiovascular symptoms (e.g. angina symptoms, cyanosis, pallor), respiratory symptoms (e.g. wheezing), nausea, falls (yes or no), other (to be described).

    Measured: Immediately after termination of exercise intervention or control condition and after awakening from follow-up (night 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2018
  2. Study start24 Sep 2018
  3. Primary completion6 Jan 2020
  4. Study completion6 Jan 2020

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03673397
Sponsor's protocol ID
EASED-trial
Acronym
EASED
Status last verified
Feb 2020
First submitted
28 Jun 2018
Last updated
7 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified (i.e. coded) individual participant data that underlie the results of published articles, including data dictionaries, will be available upon request under the creative commons license CC-BY. Requests will only be granted for use in individual participant data meta-analysis which has been approved by an independent review committee. Exceptions to these rules are reserved within the context of peer-reviewed publications, provided that data integrity remains intact. Data will be provided upon request immediately after publication of peer-reviewed articles with no end date. Requests should be sent to the e-mail address detailed in the Dataverse repository https://doi.org/10.7910/DVN/WASN36.

Publications

  • Brupbacher G, Zander-Schellenberg T, Straus D, Porschke H, Infanger D, Gerber M, von Kanel R, Schmidt-Trucksass A. The acute effects of aerobic exercise on sleep in patients with unipolar depression: a randomized controlled trial. Sleep. 2021 Nov 12;44(11):zsab177. doi: 10.1093/sleep/zsab177.

    PubMed 34255075
  • Brupbacher G, Straus D, Porschke H, Zander-Schellenberg T, Gerber M, von Kanel R, Schmidt-Trucksass A. The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial. Trials. 2019 Jun 13;20(1):352. doi: 10.1186/s13063-019-3415-3.

    PubMed 31196147

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise, bicycle ergometer in people with Depression and Sleep, run by Oberwaid AG at 1 site in Switzerland.

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 7 Feb 2020. 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 Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in sleep efficiency (%) at follow-up assessed by polysomnography (time frame: Baseline (night 1) and follow-up (night 2)). 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 NCT03673397, which also lists 2 linked publications.

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 7 Feb 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in