NCT02741622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

March 15, 2016

Last Update Submit

December 3, 2018

Conditions

Keywords

Exercise therapy

Outcome Measures

Primary Outcomes (1)

  • Change in serum brain derived neurotropic factor (BDNF)

    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 Outcomes (5)

  • Change in affective symptoms

    15 minutes before exercise to 15> minutes after exercise.

  • Change in state of anxiety.

    15 minutes before exercise and 15> minutes after exercise.

  • Change in subjective exercise experience

    15 minutes before exercise to 15> minutes after exercise.

  • Maximal oxygen uptake

    Baseline

  • Maximal Heart rate

    Baseline

Study Arms (1)

Exercise

EXPERIMENTAL

Acute High aerobic intensity training (HIT) and long slow distance training (LSD)

Behavioral: High aerobic intensity training (HIT)Behavioral: Long slow distance training (LSD)

Interventions

One training session, high aerobic intensity training (HIT) at 90-95 % of the maximal heart rate (HRmax)

Exercise

One training session, long slow distance training (LSD) at 70 % of the HRmax

Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate or severe depression (ICD10: F32-F33)

You may not qualify if:

  • Bipolar disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.Olavs university Hospital, Departement of Østmarka

Trondheim, Norway

Location

MeSH Terms

Conditions

Depressive DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Pål Sandvik, MD

    St.Olavs University Hospital, Østmarka

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 18, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations