Recruiting

Aerobic Exercise

Sponsor:

The Royal's Institute of Mental Health Research

Code:

NCT04110041

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

Interventions

Aerobic Exercise

Study Details

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).

Conditions

Depression

Study ID

NCT04110041

Start date

Aug 7, 2018

Status verified date

Apr, 2024

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Moderate Intensity

Aerobic exercise maintained for 30 minutes at 50-55% of each participant's individual heart rate reserve (HRRes).

experimental: High Intensity

Aerobic exercise maintained for 30 minutes at 80-85% of each participant's individual heart rate reserve (HRRes).

Interventions

Aerobic Exercise

Thrice-weekly aerobic exercise sessions lasting \~45 minutes, for 12 consecutive weeks.

Primary outcome measure

  • Changes in clinician-rated depression-related symptoms [ Time Frame: Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks) ]
  • 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 ]
  • Feasibility of moderate & high intensity aerobic exercise as a treatment regimen. [ Time Frame: Every 24 months from recruitment initiation until study completion ]
  • Adherence to moderate & high intensity exercise regimens as prescribed [ Time Frame: Assessed per participant, through study completion ]
  • Compliance to moderate & high intensity exercise regimens as prescribed [ Time Frame: Assessed per participant, through study completion ]

Central Contacts and Locations

Central contacts

Natalia Jaworska, PhD

613-722-6521Natalia.Jaworska@theroyal.ca

Locations

University of Ottawa Institute of Mental Health Research

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Natalia Jaworska, PhD

613-722-6521Natalia.Jaworska@theroyal.ca

More Information

Sponsor

The Royal's Institute of Mental Health Research

Last update posted

Apr 12, 2024

Last verified

Apr, 2024

Keywords

  • Transitional-aged youth
  • Exercise therapy
  • Neurocognition
  • fMRI
  • EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Royal's Institute of Mental Health Research on 2024-04-12.