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.

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.

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.

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.

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

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

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

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

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

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.