Aerobic Exercise as add-on Treatment for Inpatients With Depression

Depression Clinical Trial

Official title:

Aerobic Exercise as add-on Treatment for Inpatients With Depression: Effects and Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679053
• Other study ID #: EKBB 62/13
• Status: Completed
• Phase: N/A
• First received: January 26, 2016
• Last updated: April 10, 2017
• Start date: October 2013
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Aerobic exercise

• Placebo control

Locations

Country	Name	City	State
Switzerland	Psychiatric University Hospital	Basel
Switzerland	Psychiatric Services Solothurn	Solothurn

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Psychiatric Hospital of the University of Basel, Solothurner Spitäler AG, University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms self rated	Change in Score of Hamilton Depression Rating Scale (HDRS-17) from baseline until 6 months follow-up	Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (followup)
Primary	Depressive Symptoms physician rated	Change in Score of Beck Depression Inventory (BDI) from baseline until 6 months follow-up	Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (follow-up)
Secondary	Cortisol awakening response (CAR)	Change of Salivary cortisol increase (Area under the curve, measured at awakening, +10, +20 and +30 minutes) from baseline until 6 months follow-up	Baseline (pre), 2 weeks, 6 weeks (post), 6 months (follow-up)
Secondary	Brain derived neurotrophic factor (Serum-BDNF)	Change of Serum-BDNF	Baseline (pre), 2 weeks, 6 weeks (post), 6 months (followup)
Secondary	Sleep (Subjective sleep Quality)	Change of Score of Pittsburgh sleep quality index (PSQI) from baseline until follow-up	Baseline (pre), 6 weeks (post), 6 months (followup)
Secondary	Sleep (Polysomnography)	Change in sleep stages between baseline and follow-up	Baseline (pre), 6 weeks (post)
Secondary	Cognition	Change in performance in Executive functions (alertness, working memory, flexibility, go/nogo, divided attention) measured by "Testbatterie zur Aufmerksamkeitsprüfung" (TAP)	Baseline (pre), 6 weeks (post), 6 months (followup)
Secondary	Social stress - cortisol	Change of Salivary cortisol-course (Area under the curve) during Trier Social Stress Test (TSST)	Baseline (pre), 6 weeks (post)
Secondary	Social stress - heartrate	Change of heartrate-course during Trier Social Stress Test (TSST)	Baseline (pre), 6 weeks (post)
Secondary	Psychological symptoms	Change of scores in Symptom Checklist (SCL-90R) from baseline until follow-up	Baseline (pre), 6 weeks (post), 6 months (follow-up)
Secondary	Mental Toughness	Change in score in Mental Toughness Questionnaire (MTQ18)from baseline until follow-up	Baseline (pre), 6 weeks (post), 6 months (followup)
Secondary	Physical activity	Change of weekly physical activity as self reported by the International Physical Activity Questionnaire - Short Version (IPAQ-short)	Baseline (pre), 6 months (follow-up)
Secondary	Sleep related personality traits	Change in Focussing and Rumination subscores of the "Fragebogen zur Erfassung von Persönlichkeitsmerkmalen Schlafgestörter" (FEPS II)	Baseline (pre), 6 weeks (post), 6 months (followup)
Secondary	Body Mass Index (BMI)	Change(BMI)	Baseline (pre), 6 weeks (post), 6 months (followup)
Secondary	Resting Heartrate (HR)	Change of HR	Baseline (pre), 6 weeks (post), 6 months (followup)
Secondary	Blood Pressure (BP)	Change of BP	Baseline (pre), 6 weeks (post), 6 months (followup)
Secondary	TNF-Alpha (additional value assessed/Amendment 1)	Change of TNF-alpha	Baseline (pre), 2 weeks (post), 6 weeks (post)