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

NCT04110041 | Recruiting

• 1 other identifier: 2018025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Changes in clinician-rated depression-related symptoms

  Changes in depressive symptoms as measured by the Hamilton Depression Rating Scale (HDRS) \& Montgomery-Asberg Depression Rating Scale (MADRS).

  Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks)

• Changes in self-reported depression-related symptoms

  Changes in depressive symptoms as measured by the Beck Depression Inventory (BDI; self-reported)

  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.

  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.

  Every 24 months from recruitment initiation until study completion

• Adherence to moderate & high intensity exercise regimens as prescribed

  The number of exercise session attended by each participant (out of the total 36 sessions prescribed).

  Assessed per participant, through study completion

• Compliance to moderate & high intensity exercise regimens as prescribed

  The percentage of time, per session, that a participant spends within his/her prescribed heart rate zone.

  Assessed per participant, through study completion

Secondary Outcomes (6)

• Changes in electrocortical-indexed brain activity profiles

  Baseline & Post-Intervention (12 weeks)

• Changes to neuroimaging-indexed brain activity profiles

  Baseline & Post-Intervention (12 weeks)

• Changes to self-esteem

  Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks)

• Changes in self-mastery

  Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks)

• Changes in daily functioning

  Baseline, Mid-Intervention (6 weeks), Post-Intervention (12 weeks)

Study Arms (2)

Moderate Intensity

EXPERIMENTAL

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

Behavioral: Aerobic Exercise

High Intensity

EXPERIMENTAL

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

Behavioral: Aerobic Exercise

Interventions

Aerobic Exercise BEHAVIORAL

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

High Intensity; Moderate Intensity

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Royal's Institute of Mental Health Research: lead

Study Sites (1)

University of Ottawa Institute of Mental Health Research

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Natalia Jaworska, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Electrophysiology Laboratory

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 1, 2019
• Study Start: August 7, 2018
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CA (1)