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Effects of Aerobic Exercise Intensity on Clinical & Neural Outcomes in Depressed Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110041
Recruitment Status : Active, not recruiting
First Posted : October 1, 2019
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Natalia Jaworska, The Royal's Institute of Mental Health Research

Brief Summary:
This study will assess the effects of moderate vs. high intensity aerobic exercise, performed 3 times a week for 12 weeks under supervised conditions, on symptoms of depression, cognitive functioning and brain function in transitional aged youth (TAY: aged 16-24 years).

Condition or disease Intervention/treatment Phase
Depression Behavioral: Aerobic Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessing the Clinical & Neural Outcomes in Depressed Youth Randomized to One of Two Intensities of Aerobic Exercise
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moderate Intensity
Aerobic exercise maintained for 30 minutes at 50-55% of each participant's individual heart rate reserve (HRRes).
Behavioral: Aerobic Exercise
Thrice-weekly aerobic exercise sessions lasting ~45 minutes, for 12 consecutive weeks.

Experimental: High Intensity
Aerobic exercise maintained for 30 minutes at 80-85% of each participant's individual heart rate reserve (HRRes).
Behavioral: Aerobic Exercise
Thrice-weekly aerobic exercise sessions lasting ~45 minutes, for 12 consecutive weeks.




Primary Outcome Measures :
  1. Changes in clinician-rated depression-related symptoms [ Time Frame: Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks) ]
    Changes in depressive symptoms as measured by the Hamilton Depression Rating Scale (HDRS) & Montgomery-Asberg Depression Rating Scale (MADRS).

  2. Changes in self-reported depression-related symptoms [ Time Frame: Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks), 3-month follow-up, 6-month follow-up ]
    Changes in depressive symptoms as measured by the Beck Depression Inventory (BDI; self-reported)

  3. Feasibility of moderate & high intensity aerobic exercise as a treatment regimen. [ Time Frame: Every 24 months from recruitment initiation until study completion ]
    Operationalized as: a) recruitment and randomization - the number of individuals who are successfully screened into the study, and the number of individuals randomized to each treatment following successful screening, respectively, over a 24 month period; and b) retention - the extent to which participants remain enrolled in the study, ie the number of participants who complete follow-up testing.

  4. Adherence to moderate & high intensity exercise regimens as prescribed [ Time Frame: Assessed per participant, through study completion ]
    The number of exercise session attended by each participant (out of the total 36 sessions prescribed).

  5. Compliance to moderate & high intensity exercise regimens as prescribed [ Time Frame: Assessed per participant, through study completion ]
    The percentage of time, per session, that a participant spends within his/her prescribed heart rate zone.


Secondary Outcome Measures :
  1. Changes in electrocortical-indexed brain activity profiles [ Time Frame: Baseline & Post-Intervention (12 weeks) ]
    Assessed via EEG during computerized tasks of attention/inhibition and working memory.

  2. Changes to neuroimaging-indexed brain activity profiles [ Time Frame: Baseline & Post-Intervention (12 weeks) ]
    Assessed via fMRI during computerized tasks of attention/inhibition and working memory.

  3. Changes to self-esteem [ Time Frame: Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks) ]
    Assessed with the Rosenberg Self-Esteem Scale, a 10-item self-report questionnaire.

  4. Changes in self-mastery [ Time Frame: Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks) ]
    Assessed with Perlin/Schooler's Mastery Scale a 7-item self-report questionnaire.

  5. Changes in daily functioning [ Time Frame: Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks) ]
    Assessed via the Columbia Impairment Scale, a 13-item self-report questionnaire.

  6. Changes in cognitive function [ Time Frame: Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks) ]
    Assessed via the NIH Cognitive Toolbox; a cognitive battery consisting of 7 distinct computerized tasks assessing multiple cognitive constructs. Performance on each task is combined to produce a composite score.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently experiencing depression (MDD or PDD);
  • Free of pharmacotherapy (ie. antidepressant medication) for >5 weeks;
  • Not currently engaging in regular moderate or vigorous intensity exercise;
  • Able to read/understand English;
  • Body mass index [BMI] < 40;
  • Medically cleared to engage in aerobic exercise.

Exclusion Criteria:

  • Currently engaged in another exercise trial;
  • Another Axis I/II DSM-5 disorder, apart from co-morbid anxiety disorder(s);
  • Current or lifetime history of serious medical or neurological conditions;
  • Currently taking psychoactive drugs (occasional use of anti-anxiety medication permitted);
  • Regular user of nicotine products;
  • Unstable medical conditions, especially those that prevent exercise;
  • Exhibiting significant suicide risk;
  • MRI contraindications;
  • Currently pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110041


Locations
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Canada, Ontario
University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, Canada, K1Z 7K4
Sponsors and Collaborators
The Royal's Institute of Mental Health Research
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Responsible Party: Dr. Natalia Jaworska, Director, Clinical Electrophysiology Laboratory, The Royal's Institute of Mental Health Research
ClinicalTrials.gov Identifier: NCT04110041    
Other Study ID Numbers: 2018025
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Natalia Jaworska, The Royal's Institute of Mental Health Research:
Transitional-aged youth
Exercise therapy
Neurocognition
fMRI
EEG
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms