Feasibility of Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2023-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This project is a single-arm pilot trial to investigate the feasibility, acceptability, and plausible efficacy of a 16-week resistance exercise training (RET) program for treatment of major depressive disorder.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

RESISTance Exercise for Depression Trial

NCT06110897

Major Depressive Disorder

RECRUITING NA

Cognitive Training for Depression

NCT01936506

Major Depressive Disorder

COMPLETED PHASE1/PHASE2

Impact of an Eight Week Exercise Intervention in Treating Major Depressive Disorder

NCT03191994

Major Depressive Disorder

UNKNOWN NA

Exercise and Severe Depression: Clinical and Biological Analysis

NCT01899716

Depression

COMPLETED NA

Predictors of Depression Treatment Response to Exercise

NCT02583867

Depression Major Depressive Disorder

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Resistance exercise training (RET) is a promising but understudied approach for treatment of major depressive disorder (MDD). The purpose of this study is to assess the feasibility of recruiting eligible participants, enrolling them into the study, and retaining them across 16 weeks of resistance exercise training (RET) twice per week for treatment of depression. The primary aim of this study is to determine the feasibility (i.e., recruitment and enrollment rates) and acceptability (i.e., adherence rate, retention rate, and participant satisfaction) of running a larger study that would evaluate the efficacy of RET for treating Major Depressive Disorder (MDD). Secondary aims are to implement and examine the utility of theory-informed adherence strategies (i.e.,exercise preparation habit development and ratings, commitment contracts, and intrinsic motivation reflections) for promoting adherence to exercise sessions, explore efficacy of RET for treating MDD, and explore cerebrovascular function as a potential mechanism of RET's treatment of depression. As such, investigators will recruit 10 individuals with diagnosed MDD (via the Structured Clinical Interview for Depression) and enroll participants in a 16-week RET program. Assessments of depression, cerebrovascular functioning, physical activity, and health will be completed at weeks 0, 8, 16, with a 26-week follow-up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resistance Exercise Training

Participants will complete a 16-week, twice/week program to increase strength.

Group Type EXPERIMENTAL

Resistance Exercise Training

Intervention Type BEHAVIORAL

Participants will complete a 16-week, twice/week supervised resistance exercise training program to increase strength. Each session will last \~60 minutes and begin and end with a 5-minute aerobic warm-up/cool-down on a cycle ergometer, elliptical, treadmill, or walked laps. Training will begin with a 1-week standard familiarization process 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 10 Keiser resistance machines (i.e., leg press, hamstring curl, quadriceps extension, chest press, lat pulldown, shoulder press, biceps curl, triceps extension, abdominal crunch), with a 1-minute rest time between each set. Workload will begin at 50% of the estimated 1-RMs and increase by 5-10% after any session in which a participant completes 12 repetitions in all 3 sets. The workload will be tailored based on progressive increases in strength.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resistance Exercise Training

Participants will complete a 16-week, twice/week supervised resistance exercise training program to increase strength. Each session will last \~60 minutes and begin and end with a 5-minute aerobic warm-up/cool-down on a cycle ergometer, elliptical, treadmill, or walked laps. Training will begin with a 1-week standard familiarization process 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 10 Keiser resistance machines (i.e., leg press, hamstring curl, quadriceps extension, chest press, lat pulldown, shoulder press, biceps curl, triceps extension, abdominal crunch), with a 1-minute rest time between each set. Workload will begin at 50% of the estimated 1-RMs and increase by 5-10% after any session in which a participant completes 12 repetitions in all 3 sets. The workload will be tailored based on progressive increases in strength.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Be diagnosed with DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) MDD confirmed via Structured Clinical Interview for DSM-5
* Have current depressive symptoms of at least mild severity defined by a Hamilton Rating Scale of Depression score greater than or equal to 8
* Be ages 18-65
* Have not changed psychological treatments (including drugs, behavioral and psychological treatments) in the past 8 weeks and willing to maintain treatments throughout study enrollment
* Safe to exercise based on Physical Activity Readiness Questionnaire (PARQ) responses

Exclusion Criteria

* Currently pregnant, nursing, or planning to become pregnant during the study
* Currently diagnosed with a drug or alcohol use disorder (via SCID)
* Comorbid psychiatric conditions confirmed via SCID, with the exception of Generalized Anxiety Disorder (GAD; due to high comorbidity)
* Class II or greater level of obesity (BMI greater than or equal to 35)
* High active suicidal ideation with specific plan and intent ('4' or '5' score on Suicidal Ideation from Columbia Suicide Severity Rating Scale or '3' on QIDS)
* Currently meets US resistance exercise recommendations per week (2 days per week) for the last 8 weeks
* Self-reported prior cardiovascular event or condition, stroke or pulmonary, renal, or neurological disease
* Self-reported diabetes mellitus
* Self-reported recent (within 3 months) severe concussion, in which the individual lost consciousness for any amount of time
* Self-reported smoking/vaping

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No