Ignite Creation Date:
2024-05-06 @ 8:08 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02679053
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2016-01-26
Brief Title:
Aerobic Exercise as add-on Treatment for Inpatients With Depression
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Aerobic Exercise as add-on Treatment for Inpatients With Depression Effects and Biomarkers
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Amendment 1 Nov 2016 additional evaluation of TNF-alpha at baseline 2 weeks and post 6weeks in already existing blood samples
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 175kcalkg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None