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Completed

NCT Number: NCT02679053

Aerobic Exercise as add-on Treatment for Inpatients With Depression

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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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric University Hospital, Basel, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

Placebo control

Behavioral

Primary outcomes

  1. Depressive Symptoms self rated

    Time frame: Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (followup)

    Change in Score of Hamilton Depression Rating Scale (HDRS-17) from baseline until 6 months follow-up

  2. Depressive Symptoms physician rated

    Time frame: Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (follow-up)

    Change in Score of Beck Depression Inventory (BDI) from baseline until 6 months follow-up

Secondary outcomes

  1. Cortisol awakening response (CAR)

    Time frame: Baseline (pre), 2 weeks, 6 weeks (post), 6 months (follow-up)

    Change of Salivary cortisol increase (Area under the curve, measured at awakening, +10, +20 and +30 minutes) from baseline until 6 months follow-up

  2. Brain derived neurotrophic factor (Serum-BDNF)

    Time frame: Baseline (pre), 2 weeks, 6 weeks (post), 6 months (followup)

    Change of Serum-BDNF

  3. Sleep (Subjective sleep Quality)

    Time frame: Baseline (pre), 6 weeks (post), 6 months (followup)

    Change of Score of Pittsburgh sleep quality index (PSQI) from baseline until follow-up

  4. Sleep (Polysomnography)

    Time frame: Baseline (pre), 6 weeks (post)

    Change in sleep stages between baseline and follow-up

  5. Cognition

    Time frame: Baseline (pre), 6 weeks (post), 6 months (followup)

    Change in performance in Executive functions (alertness, working memory, flexibility, go/nogo, divided attention) measured by "Testbatterie zur Aufmerksamkeitsprüfung" (TAP)

  6. Social stress - cortisol

    Time frame: Baseline (pre), 6 weeks (post)

    Change of Salivary cortisol-course (Area under the curve) during Trier Social Stress Test (TSST)

  7. Social stress - heartrate

    Time frame: Baseline (pre), 6 weeks (post)

    Change of heartrate-course during Trier Social Stress Test (TSST)

  8. Psychological symptoms

    Time frame: Baseline (pre), 6 weeks (post), 6 months (follow-up)

    Change of scores in Symptom Checklist (SCL-90R) from baseline until follow-up

  9. Mental Toughness

    Time frame: Baseline (pre), 6 weeks (post), 6 months (followup)

    Change in score in Mental Toughness Questionnaire (MTQ18)from baseline until follow-up

  10. Physical activity

    Time frame: Baseline (pre), 6 months (follow-up)

    Change of weekly physical activity as self reported by the International Physical Activity Questionnaire - Short Version (IPAQ-short)

  11. Sleep related personality traits

    Time frame: Baseline (pre), 6 weeks (post), 6 months (followup)

    Change in Focussing and Rumination subscores of the "Fragebogen zur Erfassung von Persönlichkeitsmerkmalen Schlafgestörter" (FEPS II)

  12. Body Mass Index (BMI)

    Time frame: Baseline (pre), 6 weeks (post), 6 months (followup)

    Change(BMI)

  13. Resting Heartrate (HR)

    Time frame: Baseline (pre), 6 weeks (post), 6 months (followup)

    Change of HR

  14. Blood Pressure (BP)

    Time frame: Baseline (pre), 6 weeks (post), 6 months (followup)

    Change of BP

  15. TNF-Alpha (additional value assessed/Amendment 1)

    Time frame: Baseline (pre), 2 weeks (post), 6 weeks (post)

    Change of TNF-alpha

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Psychiatric Hospital of the University of Basel
  • Solothurner Spitäler AG
  • University of Basel

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Feb 10, 2016
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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