Depression Clinical Trial
Official title:
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
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