Aerobic Exercise as add-on Treatment for Inpatients With Depression

University Hospital Basel

Status: Completed

Conditions: Depression

Treatments: Behavioral: Aerobic exercise; Behavioral: Placebo control

Study type: Interventional

Funder types: Other

Identifiers

NCT02679053

EKBB 62/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups, including a placebo group

Exercise (IG)

Experimental group

Description:

Aerobic exercise 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. 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.

Treatment:

Behavioral: Aerobic exercise

Control (CG)

Placebo Comparator group

Description:

Basic stretching and mobilisation program 3 times per week each for approx. 40 minutes, also under supervision for 6 consecutive weeks. At the end of every week physical fitness is evaluated by the queens step test.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.

Treatment:

Behavioral: Placebo control