NCT03673397

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Oberwaid AG · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Aerobic exercise, bicycle ergometer	Exercise performed below individual anaerobic threshold for 30 minutes

Timeline

• Start date: 2018-09-24
• Primary completion: 2020-01-06
• Completion: 2020-01-06
• First posted: 2018-09-17
• Last updated: 2020-02-07

Locations

1 site across 1 country: Switzerland