Anxiety Clinical Trial
NCT number | NCT04118309 |
Other study ID # | 13-508 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 14, 2015 |
Est. completion date | April 8, 2016 |
Verified date | October 2019 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 8, 2016 |
Est. primary completion date | April 8, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Natural Sciences and Engineering Research Council, Canada |
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. — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Change in cardiorespiratory fitness from baseline to post-intervention | VO2peak test (ml/min/kg) | 11 weeks |
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