Recruiting

Resistance Exercise

Sponsor:

University of Wisconsin, Madison

Code:

NCT06110897

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

High Dose Resistance Exercise Training

Low Dose Resistance Exercise Training Group

Study Details

Brief summary:

Depression is a leading cause of disability worldwide and current treatments are ineffective for many people. This trial will investigate the efficacy of a 16-week high vs low dose resistance exercise training program for the treatment of Major Depressive Disorder (MDD) in 200 adults.

Conditions

Major Depressive Disorder

Study ID

NCT06110897

Start date

Jan 1, 2024

Status verified date

Apr, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be diagnosed with DSM-5 MDD, confirmed via Structured Clinical Interview for DSM-5 (SCID).
  • Have current depressive symptoms of at least mild severity defined by the Hamilton Rating Scale of Depression 17 greater than or equal to 8 (HAMD; using the GRID-HAMD evaluated by trained, masked raters)
  • Be ages 18-65
  • EITHER not taking any mental health medications or seeking other mental health treatment (e.g., behavioral, psychological) OR be on a stable mental health medication and/or treatment regimen for the past 8 weeks, and intend to maintain that regimen for the duration of the study
  • Safe to exercise based on physical activity screening questions or physician clearance
  • Willing to be randomized to either condition
  • have a Smartphone

Exclusion Criteria:

  • Currently pregnant, nursing, or planning to become pregnant during the trial
  • Class III+ obesity
  • Diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
  • Diagnosed with current Substance Use Disorder, via the SCID
  • Active suicidal ideation with specific plan and intent ('5' score on Suicidal Ideation from Columbia Suicide Severity Rating Scale), which would necessitate immediate emergent care
  • Exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, as assessed by clinical research personnel
  • Currently meets resistance exercise recommendations (2 days per week) for the last 8 weeks
  • Self-reporting a concussion/traumatic brain injury within the last 3 months
  • Having cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High Dose Resistance Exercise Training

Participants will complete a 16-week, twice/week progressive program beginning at a moderate intensity. Each session will last \~60 minutes and begin and end with a 5-minute warm-up/cool-down. Training will begin with standard familiarization sessions to introduce participants to the machines, teach correct lifting techniques, and ensure participant safety and comfort with each exercise machine. Participants will perform 3 sets of 8-12 repetitions on 9 different machines (i.e., leg press, hamstring curl, quadriceps extension, chest press, lat pulldown, shoulder press, biceps curl, triceps extension) and one body weight/free-weight abdominal exercise. Workload will begin at 60% of estimated 1-RM and will systematically and progressively increase during the intervention.

active comparator: Low Dose Resistance Exercise Training

Participants will complete a 16-week, twice/week progressive program beginning at a low intensity. Each session will last \~60 minutes and begin and end with a 5-minute warm-up/cool-down. Training will begin with standard familiarization sessions to introduce participants to the machines, teach correct lifting techniques, and ensure participant safety and comfort with each exercise machine. Participants will perform 3 sets of 8-12 repetitions on 9 different machines (i.e., leg press, hamstring curl, quadriceps extension, chest press, lat pulldown, shoulder press, biceps curl, triceps extension) and one body weight/free-weight abdominal exercise. Workload will begin at 30% of estimated 1-RM and will systematically and progressively increase during the intervention.

Interventions

High Dose Resistance Exercise Training

Progressive resistance exercise training

Low Dose Resistance Exercise Training Group

Progressive resistance exercise training

Primary outcome measure

  • Change in depressive symptom severity measured by GRID Hamilton Depression Rating Scale (GRID-HAM-D) [ Time Frame: Weeks 0, 8, 16, 26, 52 ]
  • Change in self-reported depression symptom severity measured by Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: Weeks 0, 1-16 (once per week across the intervention), 26, 52 ]
  • Cerebral mean blood velocity [ Time Frame: Weeks 0, 8, 16, 26, 52 ]
  • Cerebral blood velocity pulsatility [ Time Frame: Weeks 0, 8, 16, 26, 52 ]

Central Contacts and Locations

Central contacts

Taline Jouzi

608-890-0154jouzi@wisc.edu

Jeni Lansing

jlansing3@wisc.edu

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Taline Jouzi

608-890-0154jouzi@wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Resistance Exercise Training
  • Strength Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-05-05.