Feasibility of Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms

Iowa State University

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Behavioral: Resistance Exercise Training

Study type

Interventional

Funder types

Other

Identifiers

NCT05695365

21-452

Details and patient eligibility

About

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.

Full description

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.

Enrollment

9 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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