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

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

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

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