AnxietyNCT04118309
The Effects of High-intensity Interval Training on Mental Health and Inflammation
A study testing Exercise in people with Anxiety and Depressive Symptoms, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depressive Symptoms, Inflammation
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2015to 8 Apr 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-time student at McMaster University
- Speak, read and understand English
Who cannot join
- Exercising for more than 150 minutes of moderate-to-vigorous physical activity per week
About this study
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.
- Conditions
- Anxiety, Depressive Symptoms, Inflammation
- Being tested
- Exercise, Placebo
- Medical subject headings
- Anxiety Disorders, Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 11 weeks
Change in cardiorespiratory fitness from baseline to post-intervention
VO2peak test (ml/min/kg)
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start14 Sep 2015
- Primary completion8 Apr 2016
- Study completion8 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Jennifer Heisz, McMaster University
- Investigators
- Jennifer Heisz, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118309
- Sponsor's protocol ID
- 13-508
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29408464Reiss 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.
PubMed 3947307Stubbs 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.
PubMed 26523669
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-intensity Interval Training on Mental Health and Inflammation
- ClinicalTrials.gov ID
- NCT04118309
- Acronym / sponsor ID
- 13-508
- Conditions
- Anxiety, Depressive Symptoms, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 14 Sep 2015 (actual)
- Primary completion
- 8 Apr 2016 (actual)
- Study completion
- 8 Apr 2016 (actual)
- First posted
- 8 Oct 2019 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Behavioral: ExerciseThree 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 exercise group | Placebo comparator | Other: PlaceboNo 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Full-time student at McMaster University
- Speak, read and understand English
Key exclusion criteria (1 listed)
- Exercising for more than 150 minutes of moderate-to-vigorous physical activity per week
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 |
|---|---|---|
| Exercise | Behavioural | High-intensity interval training |
| Placebo | Other | Placebo exercise group |
Primary outcome
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.
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
Change in cardiorespiratory fitness from baseline to post-intervention
Time frame: 11 weeks
VO2peak test (ml/min/kg)
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 8 Oct 2019.
- Background: PubMed 29408464Paolucci 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.
- Background: PubMed 3947307Reiss 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.
- Background: PubMed 26523669Stubbs 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.
- Individual participant dataSharing planned: No. 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.
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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.
Jennifer Heisz, PhD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Anxiety and Depressive Symptoms, run by McMaster University.
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 2 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 mental illness symptoms (anxiety, depression) from baseline to post-intervention (time frame: 11 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118309, which also lists 3 linked publications.
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 8 Oct 2019.