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Aerobic Exercise as add-on Treatment for Inpatients With Depression

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ClinicalTrials.gov Identifier: NCT02679053
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : April 11, 2017
Sponsor:
Collaborators:
Psychiatric Hospital of the University of Basel
University of Basel
Solothurner Spitäler AG
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Aerobic exercise Behavioral: Placebo control Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aerobic Exercise as add-on Treatment for Inpatients With Depression: Effects and Biomarkers
Study Start Date : October 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Aerobic exercise
Placebo Comparator: 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.
Behavioral: Placebo control



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679053


Locations
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Switzerland
Psychiatric University Hospital
Basel, Switzerland, 4012
Psychiatric Services Solothurn
Solothurn, Switzerland, 4503
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Psychiatric Hospital of the University of Basel
University of Basel
Solothurner Spitäler AG
Investigators
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Principal Investigator: Christian Imboden, MD, Dr. Solothurner Spitäler AG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02679053    
Other Study ID Numbers: EKBB 62/13
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders