Clinical trial NCT02679053: Aerobic Exercise as add-on Treatment for Inpatients With Depression
Official title: Aerobic Exercise as add-on Treatment for Inpatients With Depression: Effects and Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Psychiatric Hospital of the University of Basel
name: University of Basel
name: Solothurner Spitäler AG
First posted: 2016-02-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive Symptoms self rated
timeFrame: Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (followup)
measure: Depressive Symptoms physician rated
timeFrame: Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (follow-up)
Secondary outcomes:
measure: Cortisol awakening response (CAR)
timeFrame: Baseline (pre), 2 weeks, 6 weeks (post), 6 months (follow-up)
measure: Brain derived neurotrophic factor (Serum-BDNF)
timeFrame: Baseline (pre), 2 weeks, 6 weeks (post), 6 months (followup)
measure: Sleep (Subjective sleep Quality)
timeFrame: Baseline (pre), 6 weeks (post), 6 months (followup)
measure: Sleep (Polysomnography)
timeFrame: Baseline (pre), 6 weeks (post)
measure: Cognition
timeFrame: Baseline (pre), 6 weeks (post), 6 months (followup)
measure: Social stress - cortisol
timeFrame: Baseline (pre), 6 weeks (post)
measure: Social stress - heartrate
timeFrame: Baseline (pre), 6 weeks (post)
measure: Psychological symptoms
timeFrame: Baseline (pre), 6 weeks (post), 6 months (follow-up)
measure: Mental Toughness
timeFrame: Baseline (pre), 6 weeks (post), 6 months (followup)
measure: Physical activity
timeFrame: Baseline (pre), 6 months (follow-up)
measure: Sleep related personality traits
timeFrame: Baseline (pre), 6 weeks (post), 6 months (followup)
measure: Body Mass Index (BMI)
timeFrame: Baseline (pre), 6 weeks (post), 6 months (followup)
measure: Resting Heartrate (HR)
timeFrame: Baseline (pre), 6 weeks (post), 6 months (followup)
measure: Blood Pressure (BP)
timeFrame: Baseline (pre), 6 weeks (post), 6 months (followup)
measure: TNF-Alpha (additional value assessed/Amendment 1)
timeFrame: Baseline (pre), 2 weeks (post), 6 weeks (post)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Psychiatric University Hospital
city: Solothurn
country: Switzerland
facility: Psychiatric Services Solothurn
Study officials:
affiliation: Solothurner Spitäler AG
name: Christian Imboden, MD, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imboden C, Gerber M, Beck J, Eckert A, Puhse U, Holsboer-Trachsler E, Hatzinger M. Effects of Aerobic Exercise as Add-On Treatment for Inpatients With Moderate to Severe Depression on Depression Severity, Sleep, Cognition, Psychological Well-Being, and Biomarkers: Study Protocol, Description of Study Population, and Manipulation Check. Front Psychiatry. 2019 Apr 25;10:262. doi: 10.3389/fpsyt.2019.00262. eCollection 2019.