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| Name | Class |
|---|---|
| Psychiatric Hospital of the University of Basel | OTHER |
| University of Basel | OTHER |
| Solothurner Spitäler AG | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise (IG) | Experimental | 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. |
|
| Control (CG) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise | Behavioral |
| ||
| Placebo control |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms self rated | Change in Score of Hamilton Depression Rating Scale (HDRS-17) from baseline until 6 months follow-up | Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (followup) |
| Depressive Symptoms physician rated | Change in Score of Beck Depression Inventory (BDI) from baseline until 6 months follow-up | Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (pre), 2 weeks, 6 weeks (post), 6 months (follow-up) |
| Brain derived neurotrophic factor (Serum-BDNF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Imboden, MD, Dr. | Solothurner Spitäler AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric University Hospital | Basel | Basel | 4012 | Switzerland | ||
| Psychiatric Services Solothurn |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31073292 | Derived | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
Change of Serum-BDNF |
| Baseline (pre), 2 weeks, 6 weeks (post), 6 months (followup) |
| Sleep (Subjective sleep Quality) | Change of Score of Pittsburgh sleep quality index (PSQI) from baseline until follow-up | Baseline (pre), 6 weeks (post), 6 months (followup) |
| Sleep (Polysomnography) | Change in sleep stages between baseline and follow-up | Baseline (pre), 6 weeks (post) |
| Cognition | Change in performance in Executive functions (alertness, working memory, flexibility, go/nogo, divided attention) measured by "Testbatterie zur Aufmerksamkeitsprüfung" (TAP) | Baseline (pre), 6 weeks (post), 6 months (followup) |
| Social stress - cortisol | Change of Salivary cortisol-course (Area under the curve) during Trier Social Stress Test (TSST) | Baseline (pre), 6 weeks (post) |
| Social stress - heartrate | Change of heartrate-course during Trier Social Stress Test (TSST) | Baseline (pre), 6 weeks (post) |
| Psychological symptoms | Change of scores in Symptom Checklist (SCL-90R) from baseline until follow-up | Baseline (pre), 6 weeks (post), 6 months (follow-up) |
| Mental Toughness | Change in score in Mental Toughness Questionnaire (MTQ18)from baseline until follow-up | Baseline (pre), 6 weeks (post), 6 months (followup) |
| Physical activity | Change of weekly physical activity as self reported by the International Physical Activity Questionnaire - Short Version (IPAQ-short) | Baseline (pre), 6 months (follow-up) |
| Sleep related personality traits | Change in Focussing and Rumination subscores of the "Fragebogen zur Erfassung von Persönlichkeitsmerkmalen Schlafgestörter" (FEPS II) | Baseline (pre), 6 weeks (post), 6 months (followup) |
| Body Mass Index (BMI) | Change(BMI) | Baseline (pre), 6 weeks (post), 6 months (followup) |
| Resting Heartrate (HR) | Change of HR | Baseline (pre), 6 weeks (post), 6 months (followup) |
| Blood Pressure (BP) | Change of BP | Baseline (pre), 6 weeks (post), 6 months (followup) |
| TNF-Alpha (additional value assessed/Amendment 1) | Change of TNF-alpha | Baseline (pre), 2 weeks (post), 6 weeks (post) |
| Solothurn |
| Canton of Solothurn |
| 4503 |
| Switzerland |