Depressive DisorderNCT02741622
Brain Derived Neurotropic Factor Response to Aerobic Exercise Intensity in Depressive Patients.
A study testing High aerobic intensity training (HIT) and Long slow distance training (LSD) in people with Depressive Disorder and Depressive Disorder, Major, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Depressive Disorder, Major
- What is being tested?
- High aerobic intensity training (HIT) and Long slow distance training (LSD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate or severe depression (ICD10: F32-F33)
Who cannot join
- Bipolar disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depressive Disorder, Depressive Disorder, Major
- Being tested
- High aerobic intensity training (HIT), Long slow distance training (LSD)
- Keywords
- Exercise therapy
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High aerobic intensity training (HIT)Behavioural
One training session, high aerobic intensity training (HIT) at 90-95 % of the maximal heart rate (HRmax)
Long slow distance training (LSD)Behavioural
One training session, long slow distance training (LSD) at 70 % of the HRmax
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Acute High aerobic intensity training (HIT) and long slow distance training (LSD) Receives: Behavioral: High aerobic intensity training (HIT); Behavioral: Long slow distance training (LSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum brain derived neurotropic factor (BDNF)
To measure serum BDNF levels, blood samples will be taken before and after each workout session.
Measured: 15 minutes before exercise to 5> minutes after exercise.
Secondary outcomes (5)
Change in affective symptoms
The positive and negative affect schedule (PANAS) .
Measured: 15 minutes before exercise to 15> minutes after exercise.
Change in state of anxiety.
A short form of state trait anxiety inventory for adults (STAI) is used to detect their state of anxiety.
Measured: 15 minutes before exercise and 15> minutes after exercise.
Change in subjective exercise experience
The Subjective exercise experience scale (SEES).
Measured: 15 minutes before exercise to 15> minutes after exercise.
Maximal oxygen uptake
Measured: Baseline
Maximal Heart rate
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Pål Sandvik, MD, Study director, St.Olavs University Hospital, Østmarka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741622
- Sponsor's protocol ID
- 2015/2230
- Status last verified
- Dec 2018
- First submitted
- 15 Mar 2016
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Intensity on Affective States and Brain Derived Neurotropic Factor in Patients With Depression
- ClinicalTrials.gov ID
- NCT02741622
- Acronym / sponsor ID
- 2015/2230
- Conditions
- Depressive Disorder, Depressive Disorder, Major
- Keywords
- Exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: High aerobic intensity training (HIT), Behavioral: Long slow distance training (LSD)Acute High aerobic intensity training (HIT) and long slow distance training (LSD) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate or severe depression (ICD10: F32-F33)
Key exclusion criteria (1 listed)
- Bipolar disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High aerobic intensity training (HIT)One training session, high aerobic intensity training (HIT) at 90-95 % of the maximal heart rate (HRmax) | Behavioural | Exercise |
| Long slow distance training (LSD)One training session, long slow distance training (LSD) at 70 % of the HRmax | Behavioural | Exercise |
Primary outcome
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.
5 secondary outcomes
Change in affective symptoms
Time frame: 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.
Change in subjective exercise experience
Time frame: 15 minutes before exercise to 15> minutes after exercise.
Maximal oxygen uptake
Time frame: Baseline
Maximal Heart rate
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pål Sandvik, MD study director
St.Olavs University Hospital, Østmarka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High aerobic intensity training (HIT) and Long slow distance training (LSD) in people with Depressive Disorder and Depressive Disorder, Major, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum brain derived neurotropic factor (BDNF) (time frame: 15 minutes before exercise to 5> minutes after exercise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.