- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02741622
Brain Derived Neurotropic Factor Response to Aerobic Exercise Intensity in Depressive Patients.
Effects of Aerobic Exercise Intensity on Affective States and Brain Derived Neurotropic Factor in Patients With Depression
Acute aerobic exercise improves affective stats in patients with mental illnesses. Brain derived neurotropic factor (BDNF) may be a biological mechanism that contributes to the affective benefits. The magnitude of the increase of serum BDNF might be exercise intensity dependent, but no study has compared low high-aerobic-intensity training at 90-95 % of the maximal heart rate (HRmax) with long-slow-distance training at 70 % of the HRmax in patients with depression.
The aim of this study is to compare changes in serum BDNF levels after high-aerobic-intensity training and long-slow-distance training in a intra-individual design in patients suffering from depression. The results will give indications of a possible difference in BDNF response between aerobic intensities and may be uses as pilot data for calculating sample size.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trondheim, Norway
- St.Olavs university Hospital, Departement of Østmarka
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Moderate or severe depression (ICD10: F32-F33)
Exclusion Criteria:
- Bipolar disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
Acute High aerobic intensity training (HIT) and long slow distance training (LSD)
|
One training session, high aerobic intensity training (HIT) at 90-95 % of the maximal heart rate (HRmax)
One training session, long slow distance training (LSD) at 70 % of the HRmax
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in serum brain derived neurotropic factor (BDNF)
Time Frame: 15 minutes before exercise to 5> minutes after exercise.
|
To measure serum BDNF levels, blood samples will be taken before and after each workout session.
|
15 minutes before exercise to 5> minutes after exercise.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in affective symptoms
Time Frame: 15 minutes before exercise to 15> minutes after exercise.
|
The positive and negative affect schedule (PANAS) .
|
15 minutes before exercise to 15> minutes after exercise.
|
|
Change in state of anxiety.
Time Frame: 15 minutes before exercise and 15> minutes after exercise.
|
A short form of state trait anxiety inventory for adults (STAI) is used to detect their state of anxiety.
|
15 minutes before exercise and 15> minutes after exercise.
|
|
Change in subjective exercise experience
Time Frame: 15 minutes before exercise to 15> minutes after exercise.
|
The Subjective exercise experience scale (SEES).
|
15 minutes before exercise to 15> minutes after exercise.
|
|
Maximal oxygen uptake
Time Frame: Baseline
|
Baseline
|
|
|
Maximal Heart rate
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Pål Sandvik, MD, St.Olavs University Hospital, Østmarka
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/2230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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