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Aerobic Exercise as add-on Treatment for Inpatients With Depression

University Hospital Basel logo

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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