Aerobic Exercise as add-on Treatment for Inpatients With Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Exercise (IG)

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.

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

Control (CG)

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.

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type BEHAVIORAL

Interventions

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Aerobic exercise

Intervention Type BEHAVIORAL

Placebo control

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No