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The Effects of High-intensity Interval Training on Mental Health and Inflammation

Primary Purpose

Anxiety, Depressive Symptoms, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Placebo
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    High-intensity interval training

    Placebo exercise group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in mental illness symptoms (anxiety, depression) from baseline to post-intervention
    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.
    Change in concentration of circulating proinflammatory cytokines (Interleukin-6, Interleukin-1 beta, Tumour necrosis factor alpha) from baseline to post-intervention
    Picogram measured from venous blood sample
    Change in cardiorespiratory fitness from baseline to post-intervention
    VO2peak test (ml/min/kg)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 3, 2019
    Last Updated
    October 4, 2019
    Sponsor
    McMaster University
    Collaborators
    Natural Sciences and Engineering Research Council, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04118309
    Brief Title
    The Effects of High-intensity Interval Training on Mental Health and Inflammation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 14, 2015 (Actual)
    Primary Completion Date
    April 8, 2016 (Actual)
    Study Completion Date
    April 8, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McMaster University
    Collaborators
    Natural Sciences and Engineering Research Council, Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Depressive Symptoms, Inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High-intensity interval training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo exercise group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Change in mental illness symptoms (anxiety, depression) from baseline to post-intervention
    Description
    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.
    Time Frame
    11 weeks
    Title
    Change in concentration of circulating proinflammatory cytokines (Interleukin-6, Interleukin-1 beta, Tumour necrosis factor alpha) from baseline to post-intervention
    Description
    Picogram measured from venous blood sample
    Time Frame
    11 weeks
    Title
    Change in cardiorespiratory fitness from baseline to post-intervention
    Description
    VO2peak test (ml/min/kg)
    Time Frame
    11 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer Heisz, PhD
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    29408464
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    3947307
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26523669
    Citation
    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.
    Results Reference
    background

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    The Effects of High-intensity Interval Training on Mental Health and Inflammation

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