- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04118309
The Effects of High-intensity Interval Training on Mental Health and Inflammation
October 4, 2019 updated by: Jennifer Heisz, McMaster University
The present study investigated the effects of high-intensity interval exercise training and placebo-exercise on mental health and inflammation using a randomized control trial.
The study also examined how anxiety symptoms prior to high-intensity interval training may influence improvements in fitness.
Inactive young adults underwent nine weeks of either high-intensity interval training or their regular routine.
Questionnaires, a blood draw and a maximal exercise test were conducted the week before and week after the intervention.
It was hypothesized those who underwent high-intensity interval training would experience greater reductions in their depression, anxiety, and inflammation than those who were in the placebo control group.
It was also hypothesized those who had high anxiety symptoms at the start of high-intensity interval training would experience smaller improvements in fitness than those who had low anxiety symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Full-time student at McMaster University
- Speak, read and understand English
Exclusion Criteria:
- Exercising for more than 150 minutes of moderate-to-vigorous physical activity per week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-intensity interval training
Three sessions of high-intensity interval training per week for nine weeks.
Following a three minute warm up, a session contained twenty minutes of alternating between a sprint (80% of maximum workload, 90-95% of maximum heart rate) and active rest (30% of maximum workload) at a one minute to one minute ratio.
Every session ended with a two and a half minute cool down.
|
|
Placebo Comparator: Placebo exercise group
No changes in physical activity behaviour occurred (already engaging in less than 150 minutes per week, instructed to maintain their current inactivity).
They were told they needed to stay inactive since they were part of an 'acute' exercise group, aiming to see how long the effects of their baseline maximal exercise test would last.
Thus, the cover story gave them the impression they were also in an exercise group, as oppose to a non-exercise control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mental illness symptoms (anxiety, depression) from baseline to post-intervention
Time Frame: 11 weeks
|
The 21-items of the Beck Anxiety Inventory (Beck, Brown, Epstein & Steer, 1998) are summed to produce a total score from 0-63, with a higher score reflecting more severe anxiety symptoms.
The 21-items of the Beck Depression Inventory (Beck, Steer, & Brown, 1996) are summed to produce a total score from 0-63, with a higher score reflecting more severe depressive symptoms.
|
11 weeks
|
Change in concentration of circulating proinflammatory cytokines (Interleukin-6, Interleukin-1 beta, Tumour necrosis factor alpha) from baseline to post-intervention
Time Frame: 11 weeks
|
Picogram measured from venous blood sample
|
11 weeks
|
Change in cardiorespiratory fitness from baseline to post-intervention
Time Frame: 11 weeks
|
VO2peak test (ml/min/kg)
|
11 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Heisz, PhD, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Reiss S, Peterson RA, Gursky DM, McNally RJ. Anxiety sensitivity, anxiety frequency and the prediction of fearfulness. Behav Res Ther. 1986;24(1):1-8. doi: 10.1016/0005-7967(86)90143-9. No abstract available.
- Paolucci EM, Loukov D, Bowdish DME, Heisz JJ. Exercise reduces depression and inflammation but intensity matters. Biol Psychol. 2018 Mar;133:79-84. doi: 10.1016/j.biopsycho.2018.01.015. Epub 2018 Feb 3.
- Stubbs B, Rosenbaum S, Vancampfort D, Ward PB, Schuch FB. Exercise improves cardiorespiratory fitness in people with depression: A meta-analysis of randomized control trials. J Affect Disord. 2016 Jan 15;190:249-253. doi: 10.1016/j.jad.2015.10.010. Epub 2015 Oct 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2015
Primary Completion (Actual)
April 8, 2016
Study Completion (Actual)
April 8, 2016
Study Registration Dates
First Submitted
October 3, 2019
First Submitted That Met QC Criteria
October 4, 2019
First Posted (Actual)
October 8, 2019
Study Record Updates
Last Update Posted (Actual)
October 8, 2019
Last Update Submitted That Met QC Criteria
October 4, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The sharing of individual data with other researchers was not included in the informed consent signed by participants.
Therefore, individual data will not be released.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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