Clinical trial NCT03673397: The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
Official title: The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Sleep
Sleep Disorder
Sleep Disturbance
Sleep Fragmentation
Sleep Initiation and Maintenance Disorders
Insomnia
Insomnia, Psychophysiological
Insomnia Due to Other Mental Disorder
Insomnia Related to Another Mental Condition
Keywords: Exercise
Sleep
Depression
Heart rate variability
Blood pressure
randomized controlled trial
polysomnography
Lead sponsor: Oberwaid AG
Sponsor class: OTHER
Collaborators: name: Institute for Exercise and Health Sciences, University of Basle, Switzerland
name: University of Zurich
name: University of Basel
First posted: 2018-09-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in sleep efficiency (%) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
Secondary outcomes:
measure: Change from baseline in wake after sleep onset (minutes) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in sleep onset latency (minutes) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in number of awakenings at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in stage 1 sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in stage 2 sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in stage 3 sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in rapid eye movement sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in light sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in non-rapid eye movement sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in rapid eye movement sleep-latency (minutes) at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in stage shift index at follow-up assessed by polysomnography
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in subjective sleep quality at follow-up assessed by self-rated questionnaire 'revised Schlaffragebogen A'
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in subjective pre-sleep arousal at follow-up assessed by self-rated questionnaire 'Pre-Sleep Arousal Scale'
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in pre-sleep autonomic modulation at follow-up
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in nocturnal autonomic modulation at follow up
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: Change from baseline in post-sleep autonomic modulation at follow-up
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: 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)
timeFrame: Baseline (night 1) and follow-up (night 2)
measure: State sleepiness assessed by self-rated questionnaire 'Stanford Sleepiness Scale' (SSS)
timeFrame: Day 5 (i.e. day after night 2): at 08:00 am, 12 noon, 04:00 pm, and 08:00 pm
measure: Difference in adverse events between exercise and control group
timeFrame: Immediately after termination of exercise intervention or control condition and after awakening from follow-up (night 2)
Other outcomes:
measure: Mood assessed by self-rating questionnaire 'Befindlichkeitsskala' (BFS)
timeFrame: Immediately before and at the end of the control condition as well as the exercise intervention.
Locations:
city: St.Gallen
country: Switzerland
facility: Oberwaid Ag
Study officials:
affiliation: Oberwaid AG
name: Gavin Brupbacher, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Oberwaid AG
name: Hildburg Hildburg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.