NCT04118309

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable anxiety

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

September 14, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2016

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 3, 2019

Last Update Submit

October 4, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    11 weeks

  • 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

    11 weeks

  • Change in cardiorespiratory fitness from baseline to post-intervention

    VO2peak test (ml/min/kg)

    11 weeks

Study Arms (2)

High-intensity interval training

EXPERIMENTAL

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.

Behavioral: Exercise

Placebo exercise group

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

ExerciseBEHAVIORAL
High-intensity interval training
PlaceboOTHER
Placebo exercise group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Full-time student at McMaster University
  • Speak, read and understand English

You may not qualify if:

  • Exercising for more than 150 minutes of moderate-to-vigorous physical activity per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 29408464BACKGROUND
  • 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.

    PMID: 3947307BACKGROUND
  • 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.

    PMID: 26523669BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionInflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jennifer Heisz, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 8, 2019

Study Start

September 14, 2015

Primary Completion

April 8, 2016

Study Completion

April 8, 2016

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

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.