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DepressionNCT02679053

Aerobic Exercise as add-on Treatment for Inpatients With Depression

A study testing Aerobic exercise in people with Depression, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Depression
What is being tested?
Aerobic exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
2 sitesSwitzerland
Study dates
Oct 2013to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Inpatient treatment on the Depression ward
  • International Classification of Diseases (ICD)-10: F32, F33 or F31
  • HDRS-17>16 Points
  • written informed consent

Who cannot join

  • 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
Show all 9Show fewer
  • comorbid substance dependence (except nicotine)
  • Major comorbid psychiatric disorder
  • regular high intensity exercise prior to treatment

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Psychiatric University Hospital

    Basel, Basel, 4012

  • Psychiatric Services Solothurn

    Solothurn, Canton of Solothurn, 4503

Other trials in Switzerland

About this study

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

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.

Conditions
Depression
Being tested
Aerobic exercise, Placebo control
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02679053
Study groupRoleWhat they receive
Exercise (IG)ExperimentalAerobic 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.
Receives: Behavioral: Aerobic exercise
Control (CG)Placebo comparatorBasic 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.
Receives: Behavioral: Placebo control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depressive Symptoms self rated

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

    Measured: 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

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

Secondary outcomes (15)

  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

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

  2. Brain derived neurotrophic factor (Serum-BDNF)

    Change of Serum-BDNF

    Measured: 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

    Measured: Baseline (pre), 6 weeks (post), 6 months (followup)

  4. Sleep (Polysomnography)

    Change in sleep stages between baseline and follow-up

    Measured: 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)

    Measured: 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)

    Measured: Baseline (pre), 6 weeks (post)

  7. Social stress - heartrate

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

    Measured: Baseline (pre), 6 weeks (post)

  8. Psychological symptoms

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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: Baseline (pre), 6 weeks (post), 6 months (followup)

  12. Body Mass Index (BMI)

    Change(BMI)

    Measured: Baseline (pre), 6 weeks (post), 6 months (followup)

  13. Resting Heartrate (HR)

    Change of HR

    Measured: Baseline (pre), 6 weeks (post), 6 months (followup)

  14. Blood Pressure (BP)

    Change of BP

    Measured: Baseline (pre), 6 weeks (post), 6 months (followup)

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

    Change of TNF-alpha

    Measured: Baseline (pre), 2 weeks (post), 6 weeks (post)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2016 (estimated)
  2. Study startOct 2013
  3. Primary completionFeb 2016
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02679053
Sponsor's protocol ID
EKBB 62/13
Status last verified
Apr 2017
First submitted
26 Jan 2016
Last updated
11 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise in people with Depression, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive Symptoms self rated (time frame: Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (followup)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02679053, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.

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