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CompletedNCT02679053Updated Apr 11, 2017

Aerobic Exercise as add-on Treatment for Inpatients With Depression

An interventional study of Aerobic exercise and Placebo control in Depression, sponsored by University Hospital, Basel, Switzerland. Completed at 2 sites in Switzerland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-11.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression

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03

In context

Depression

8,245 studies on the registry are indexed under Depression; 1,645 are open to participants now.

This study's enrollment of 49 is below the median of 84 across 6,873 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 189 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
49 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralAerobic exercise
  • BehavioralPlacebo control
06

What researchers measure

Primary outcomes

  1. Depressive Symptoms self rated

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

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

  2. Depressive Symptoms physician rated

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

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

Secondary outcomes

  1. Cortisol awakening response (CAR)

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

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

  2. Brain derived neurotrophic factor (Serum-BDNF)

    Change of Serum-BDNF

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

  3. Sleep (Subjective sleep Quality)

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

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

  4. Sleep (Polysomnography)

    Change in sleep stages between baseline and follow-up

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

  5. Cognition

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

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

  6. Social stress - cortisol

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

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

  7. Social stress - heartrate

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

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

  8. Psychological symptoms

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

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

  9. Mental Toughness

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

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

  10. Physical activity

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

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

  11. Sleep related personality traits

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

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

  12. Body Mass Index (BMI)

    Change(BMI)

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

  13. Resting Heartrate (HR)

    Change of HR

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

  14. Blood Pressure (BP)

    Change of BP

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

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

    Change of TNF-alpha

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

07

Study locations

2 sites
  • Psychiatric University Hospital
    Basel, Basel 4012, Switzerland
  • Psychiatric Services Solothurn
    Solothurn, Canton of Solothurn 4503, Switzerland
08

References and documents

Publications

  • Imboden C, Gerber M, Beck J, Eckert A, Puhse U, Holsboer-Trachsler E, Hatzinger M. Effects of Aerobic Exercise as Add-On Treatment for Inpatients With Moderate to Severe Depression on Depression Severity, Sleep, Cognition, Psychological Well-Being, and Biomarkers: Study Protocol, Description of Study Population, and Manipulation Check. Front Psychiatry. 2019 Apr 25;10:262. doi: 10.3389/fpsyt.2019.00262. eCollection 2019. PubMed 31073292 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2013, a primary completion of Feb 2016 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2016
First posted
Feb 10, 2016
Start
Oct 2013
Primary completionActual
Feb 2016
CompletionActual
Mar 2017
Last update
Apr 11, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02679053
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
Psychiatric Hospital of the University of Basel, University of Basel, Solothurner Spitäler AG
Responsible party
Sponsor
First posted
Feb 10, 2016
Start date
Oct 2013
Primary completion
Feb 2016
Completion
Mar 2017
Last update
Apr 11, 2017

Study contacts

Christian Imboden, MD, Dr.
principal investigator · Solothurner Spitäler AG

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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