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

Oberwaid AG

Status: Completed

Conditions: Insomnia Related to Another Mental Condition; Sleep Initiation and Maintenance Disorders; Sleep Disorder; Sleep Fragmentation; Insomnia, Psychophysiological; Insomnia; Sleep Disturbance; Depression; Insomnia Due to Other Mental Disorder; Sleep

Treatments: Behavioral: Aerobic exercise, bicycle ergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT03673397

EASED-trial

Details and patient eligibility

About

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

Full 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

Enrollment: 92 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Aerobic exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Aerobic exercise, bicycle ergometer

Control

No Intervention group

Description:

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.