Brain Derived Neurotropic Factor Response to Aerobic Exercise Intensity in Depressive Patients.
Primary Purpose
Depressive Disorder, Depressive Disorder, Major
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High aerobic intensity training (HIT)
Long slow distance training (LSD)
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring Exercise therapy
Eligibility Criteria
Inclusion Criteria:
- Moderate or severe depression (ICD10: F32-F33)
Exclusion Criteria:
- Bipolar disorder.
Sites / Locations
- St.Olavs university Hospital, Departement of Østmarka
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
Acute High aerobic intensity training (HIT) and long slow distance training (LSD)
Outcomes
Primary Outcome Measures
Change in serum brain derived neurotropic factor (BDNF)
To measure serum BDNF levels, blood samples will be taken before and after each workout session.
Secondary Outcome Measures
Change in affective symptoms
The positive and negative affect schedule (PANAS) .
Change in state of anxiety.
A short form of state trait anxiety inventory for adults (STAI) is used to detect their state of anxiety.
Change in subjective exercise experience
The Subjective exercise experience scale (SEES).
Maximal oxygen uptake
Maximal Heart rate
Full Information
NCT ID
NCT02741622
First Posted
March 15, 2016
Last Updated
December 3, 2018
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02741622
Brief Title
Brain Derived Neurotropic Factor Response to Aerobic Exercise Intensity in Depressive Patients.
Official Title
Effects of Aerobic Exercise Intensity on Affective States and Brain Derived Neurotropic Factor in Patients With Depression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depressive Disorder, Major
Keywords
Exercise therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Acute High aerobic intensity training (HIT) and long slow distance training (LSD)
Intervention Type
Behavioral
Intervention Name(s)
High aerobic intensity training (HIT)
Intervention Description
One training session, high aerobic intensity training (HIT) at 90-95 % of the maximal heart rate (HRmax)
Intervention Type
Behavioral
Intervention Name(s)
Long slow distance training (LSD)
Intervention Description
One training session, long slow distance training (LSD) at 70 % of the HRmax
Primary Outcome Measure Information:
Title
Change in serum brain derived neurotropic factor (BDNF)
Description
To measure serum BDNF levels, blood samples will be taken before and after each workout session.
Time Frame
15 minutes before exercise to 5> minutes after exercise.
Secondary Outcome Measure Information:
Title
Change in affective symptoms
Description
The positive and negative affect schedule (PANAS) .
Time Frame
15 minutes before exercise to 15> minutes after exercise.
Title
Change in state of anxiety.
Description
A short form of state trait anxiety inventory for adults (STAI) is used to detect their state of anxiety.
Time Frame
15 minutes before exercise and 15> minutes after exercise.
Title
Change in subjective exercise experience
Description
The Subjective exercise experience scale (SEES).
Time Frame
15 minutes before exercise to 15> minutes after exercise.
Title
Maximal oxygen uptake
Time Frame
Baseline
Title
Maximal Heart rate
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate or severe depression (ICD10: F32-F33)
Exclusion Criteria:
Bipolar disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pål Sandvik, MD
Organizational Affiliation
St.Olavs University Hospital, Østmarka
Official's Role
Study Director
Facility Information:
Facility Name
St.Olavs university Hospital, Departement of Østmarka
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Brain Derived Neurotropic Factor Response to Aerobic Exercise Intensity in Depressive Patients.
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