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

NCT ID: NCT03673397

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-24
• Study Completion Date: 2020-01-06

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic exercise

Patients 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.

Group Type: EXPERIMENTAL

Aerobic exercise, bicycle ergometer

Intervention Type: BEHAVIORAL

Exercise performed below individual anaerobic threshold for 30 minutes

Control

Individuals 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerobic exercise, bicycle ergometer

Exercise performed below individual anaerobic threshold for 30 minutes

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Exercise and Health Sciences, University of Basle, Switzerland

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: collaborator

Oberwaid AG

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gavin Brupbacher, MSc

Role: PRINCIPAL_INVESTIGATOR

Oberwaid AG

Hildburg Hildburg, MD

Role: PRINCIPAL_INVESTIGATOR

Oberwaid AG

Locations

Oberwaid Ag

Sankt Gallen, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 34255075 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31196147 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

EASED-trial

Identifier Type: -

Identifier Source: org_study_id