The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Oberwaid AG
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Change from baseline in sleep efficiency (%) at follow-up assessed by polysomnography
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change from baseline in sleep efficiency (%) at follow-up assessed by polysomnography
Time Frame: Baseline (night 1) and follow-up (night 2)
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.
Secondary Outcomes
- 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 rapid eye movement 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 sleep onset latency (minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
- Change from baseline in nocturnal autonomic modulation at follow up(Baseline (night 1) and follow-up (night 2))
- Difference in adverse events between exercise and control group(Immediately after termination of exercise intervention or control condition and after awakening from 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 3 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 non-rapid eye movement 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 shift index at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
- 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 light 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 rapid eye movement sleep-latency (minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
- Change from baseline in subjective sleep quality at follow-up assessed by self-rated questionnaire 'revised Schlaffragebogen A'(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))
- Change from baseline in pre-sleep autonomic modulation at follow-up(Baseline (night 1) and follow-up (night 2))
- Change from baseline in post-sleep autonomic modulation at follow-up(Baseline (night 1) and follow-up (night 2))
- Change from baseline in nocturnal mean arterial pressure at follow-up assessed by pulse transit time (ECG, modified lead II; fingertip photoplethysmogram, single initial calibration measurement)(Baseline (night 1) and follow-up (night 2))
- Change from baseline in subjective pre-sleep arousal at follow-up assessed by self-rated questionnaire 'Pre-Sleep Arousal Scale'(Baseline (night 1) and follow-up (night 2))
- State sleepiness assessed by self-rated questionnaire 'Stanford Sleepiness Scale' (SSS)(Day 5 (i.e. day after night 2): at 08:00 am, 12 noon, 04:00 pm, and 08:00 pm)