Aerobic Exercise as add-on Treatment for Inpatients With Depression

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT02679053
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as adon treatment for moderately to severely depressed inpatients. Endpoints are symptom severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV).

Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post (+6weeks) in already existing blood samples.

Detailed Description

Patients are randomly assigned to the intervention group (IG) or control group (CG). The IG will train three times per week on indoor bicycles at 60 to 75% of maximal heartrate aiming at a weekly total of 17.5kcal/kg bodyweight for 6 consecutive weeks. The exercise will take place under supervision. CG will absolve a basic stretching and mobilisation program 3 times per week, also under supervision for 6 consecutive weeks. At the end of every week physical fitness is evaluated by the queens step test. No other activities with moderate or high intensity are allowed throughout the intervention time.

All patients will participate in the multimodal treatment program of the depression ward, which includes pharmacotherapy, psychotherapy and specialized therapies such as art therapy and ergotherapy.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2016-01-26
• Primary Completion: 2016-02
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Inpatient treatment on the Depression ward
• International Classification of Diseases (ICD)-10: F32, F33 or F31
• HDRS-17>16 Points
• written informed consent

Exclusion Criteria

• Any physical condition that prohibits endurance exercise
• 3 or more cardiovascular risk factors (hypertonia, family history, smoking, hypertriglyceridemia, diabetes)
• pathological ECG
• BMI > 35 kg/m2
• Pregnancy
• acute suicidal Ideation
• comorbid substance dependence (except nicotine)
• Major comorbid psychiatric disorder
• regular high intensity exercise prior to treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms self rated	Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (followup)	Change in Score of Hamilton Depression Rating Scale (HDRS-17) from baseline until 6 months follow-up
Depressive Symptoms physician rated	Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (follow-up)	Change in Score of Beck Depression Inventory (BDI) from baseline until 6 months follow-up

Secondary Outcome Measures

Name	Time	Method
Psychological symptoms	Baseline (pre), 6 weeks (post), 6 months (follow-up)	Change of scores in Symptom Checklist (SCL-90R) from baseline until follow-up
Sleep (Polysomnography)	Baseline (pre), 6 weeks (post)	Change in sleep stages between baseline and follow-up
Social stress - cortisol	Baseline (pre), 6 weeks (post)	Change of Salivary cortisol-course (Area under the curve) during Trier Social Stress Test (TSST)
Mental Toughness	Baseline (pre), 6 weeks (post), 6 months (followup)	Change in score in Mental Toughness Questionnaire (MTQ18)from baseline until follow-up
Cognition	Baseline (pre), 6 weeks (post), 6 months (followup)	Change in performance in Executive functions (alertness, working memory, flexibility, go/nogo, divided attention) measured by "Testbatterie zur Aufmerksamkeitsprüfung" (TAP)
Physical activity	Baseline (pre), 6 months (follow-up)	Change of weekly physical activity as self reported by the International Physical Activity Questionnaire - Short Version (IPAQ-short)
TNF-Alpha (additional value assessed/Amendment 1)	Baseline (pre), 2 weeks (post), 6 weeks (post)	Change of TNF-alpha
Cortisol awakening response (CAR)	Baseline (pre), 2 weeks, 6 weeks (post), 6 months (follow-up)	Change of Salivary cortisol increase (Area under the curve, measured at awakening, +10, +20 and +30 minutes) from baseline until 6 months follow-up
Sleep (Subjective sleep Quality)	Baseline (pre), 6 weeks (post), 6 months (followup)	Change of Score of Pittsburgh sleep quality index (PSQI) from baseline until follow-up
Social stress - heartrate	Baseline (pre), 6 weeks (post)	Change of heartrate-course during Trier Social Stress Test (TSST)
Brain derived neurotrophic factor (Serum-BDNF)	Baseline (pre), 2 weeks, 6 weeks (post), 6 months (followup)	Change of Serum-BDNF
Sleep related personality traits	Baseline (pre), 6 weeks (post), 6 months (followup)	Change in Focussing and Rumination subscores of the "Fragebogen zur Erfassung von Persönlichkeitsmerkmalen Schlafgestörter" (FEPS II)
Body Mass Index (BMI)	Baseline (pre), 6 weeks (post), 6 months (followup)	Change(BMI)
Resting Heartrate (HR)	Baseline (pre), 6 weeks (post), 6 months (followup)	Change of HR
Blood Pressure (BP)	Baseline (pre), 6 weeks (post), 6 months (followup)	Change of BP

Trial Locations

Locations (2)

Psychiatric University Hospital; 🇨🇭 Basel, Switzerland

Psychiatric Services Solothurn; 🇨🇭 Solothurn, Switzerland