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

NCT03673397 | Completed DMC

• 1 other identifier: EASED-trial
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (19)

• Change from baseline in wake after sleep onset (minutes) at follow-up assessed by polysomnography

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

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

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

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

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

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

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

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

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

Other Outcomes (1)

• Mood assessed by self-rating questionnaire 'Befindlichkeitsskala' (BFS)

  Immediately before and at the end of the control condition as well as the exercise intervention.

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

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.

Behavioral: Aerobic exercise, bicycle ergometer

Control

NO INTERVENTION

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.

Interventions

Aerobic exercise, bicycle ergometer BEHAVIORAL

Exercise performed below individual anaerobic threshold for 30 minutes

Aerobic exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oberwaid AG: lead
• Institute for Exercise and Health Sciences, University of Basle, Switzerland: collaborator
• University of Zurich: collaborator
• University of Basel: collaborator

Study Sites (1)

Oberwaid Ag

Sankt Gallen, 9016, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 34255075 DERIVED

• 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.

  PMID: 31196147 DERIVED

MeSH Terms

Conditions

Depression; Sleep Wake Disorders; Parasomnias; Sleep Deprivation; Sleep Initiation and Maintenance Disorders; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Dyssomnias; Sleep Disorders, Intrinsic

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gavin Brupbacher, MSc

  Oberwaid AG

  PRINCIPAL INVESTIGATOR

• Hildburg Hildburg, MD

  Oberwaid AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: September 17, 2018
• Study Start: September 24, 2018
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CH (1)