Clinical trial NCT05695365: Feasibility of Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms
Official title: Feasibility of Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Resistance Exercise
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and enrollment rates (feasibility)
timeFrame: Week 26
measure: Participant satisfaction (acceptability)
timeFrame: Week 26
measure: Retention (acceptability)
timeFrame: Week 26
measure: Adherence (acceptability)
timeFrame: Week 26
measure: Change in exercise preparation habit ratings
timeFrame: Change from week 1 habit ratings at week 16
measure: Change in level of commitment
timeFrame: Change from week 1 level of commitment at week 16
measure: Change in depression symptom severity via GRID-Hamilton Depression Rating Scale (HAM-D)
timeFrame: Change from baseline depression severity at the final assessment
measure: Change in depression diagnosis via Structured Clinical Interview for DSM-5 Disorders (SCID)
timeFrame: Change from baseline depression diagnosis at the final assessment
measure: Change in depressive symptoms severity via the Quick Inventory of Depressive Symptoms (QIDS)
timeFrame: Change from baseline depression symptoms severity at the final assessment
measure: Change in Transcranial Doppler ultrasound of Middle Cerebral Artery (MCA) blood flow velocity
timeFrame: Change in baseline blood flow velocity at the final assessment
measure: Change in Transcranial Doppler ultrasound of Middle Cerebral Artery (MCA) blood flow pulsatility
timeFrame: Change in baseline blood flow pulsatility at the final assessment
Secondary outcomes:
measure: Columbia-Suicide Severity Rating Scale (CSSRS)
timeFrame: Weeks 0, 8, 16, 26
measure: Estimated 1 Repetition Maximum (RM) Strength Test
timeFrame: Weeks 0, 8, 16, 26
measure: Grip Strength
timeFrame: Weeks 0, 8, 16, 26
measure: Arterial Stiffness
timeFrame: Weeks 0, 8, 16, 26
measure: Carotid Structure
timeFrame: Weeks 0, 8, 16, 26
measure: International Physical Activity Questionnaire Short Form
timeFrame: Weeks 0, 8, 16, 26
measure: activPAL (sedentary time and MVPA)
timeFrame: Monitors worn for 7 days following week 0 (intake assessment) and 7 days prior to week 8 and 16 assessments
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Weeks 0, 8, 16, 26
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Weeks 0, 8, 16, 26
measure: Perceived Stress Scale (PSS-10)
timeFrame: Weeks 0, 8, 16, 26
measure: Exercise Identity Scale (EIS)
timeFrame: Weeks 0, 8, 16, 26
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
References: