Feasibility of Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms

NCT05695365 | Completed

• 1 other identifier: 21-452
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Resistance Exercise

Outcome Measures

Primary Outcomes (11)

• Recruitment and enrollment rates (feasibility)

  Screening responses and timestamps will be used to assess the success of recruitment strategies and recruitment rate, calculated by taking the total number of participants recruited (i.e., completed screening survey) divided by the recruitment period duration. Enrollment rate will be calculated by taking the total number of participants enrolled divided by the recruitment period duration.

  Week 26

• Participant satisfaction (acceptability)

  Participant satisfaction will be assessed using a mixed-method approach, capturing self-reported ratings of satisfaction with the RET program (six questions regarding satisfaction with responses ranging from 0-46, with higher scores indicating greater level of satisfaction) corroborated by a qualitative semi-structured interview, with responses analyzed using a thematic qualitative analysis.

  Week 26

• Retention (acceptability)

  The retention rate will be calculated based on the percentage of participants that complete all study visits.

  Week 26

• Adherence (acceptability)

  The adherence rate will be calculated based on the percent of total study visits (i.e., assessment visits and RET sessions) completed within +/-7 days of the scheduled visit date for each participant.

  Week 26

• Change in exercise preparation habit ratings

  To facilitate exercise adherence, participants will develop exercise preparation habit action and coping plans during their baseline visit. These plans will subsequently be assessed weekly during exercise sessions, with participants responding to 3 questions regarding their success in developing exercise preparation habits. Using a 5-point Likert scale ranging from "Never" to "Every Time", participants will report 1) how well they were able to stick to their exercise preparation habit action and coping plans, 2) carried through with preparation steps when their identified cue was encountered, and 3) completed the habit without the planned cue. They were also provided an opportunity to revise their habit action and coping plan if their current plan was not successful the previous week.

  Change from week 1 habit ratings at week 16

• Change in level of commitment

  Participants will be asked to report their current level of commitment to the 16-week program and attending their next exercise session via a visual analogue scale anchored with "0" (0% committed) to "100" (100% committed). They subsequently responded to free-text questions related to what they needed to do or what the research team could do to increase their level of commitment. Next, they answered the question "Will you attend your next RET session?" (yes/no response buttons), and then provided an electronic signature confirming they would attend.

  Change from week 1 level of commitment at week 16

• Change in depression symptom severity via GRID-Hamilton Depression Rating Scale (HAM-D)

  The GRID-HAM-D is a clinician-completed questionnaire that will be used to rate depressive symptom severity. The questionnaire is designed for adults and is used to rate the intensity and frequency of depressive symptoms by probing mood, feelings of guilt, suicidal ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Clinical Interviewers will follow the Structured Interview Guide and use GRID scoring, in which dimensions of intensity and frequency of a symptom are rated independently for each item. Higher scores reflect greater symptom severity, categorized as Normal (0-7), Mild Depression (8-13), Moderate Depression (14-18), Severe Depression (19-22), and Very Severe Depression (\>23).

  Change from baseline depression severity at the final assessment

• Change in depression diagnosis via Structured Clinical Interview for DSM-5 Disorders (SCID)

  This is a clinician-administered semi-structured interview guide for making diagnoses according to the diagnostic criteria published in the American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders (DSM-5). It provides diagnoses for depressive and bipolar disorders, schizophrenia spectrum and other psychotic disorders, substance use disorders, anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder), obsessive-compulsive disorder, posttraumatic stress disorder, attention-deficit/hyperactivity disorder, and adjustment disorder. The SCID will be administered by a Clinical Interviewer to diagnose Major Depressive Disorder and assess for exclusion criteria in this study.

  Change from baseline depression diagnosis at the final assessment

• Change in depressive symptoms severity via the Quick Inventory of Depressive Symptoms (QIDS)

  This is a self-administered 16-item questionnaire that assesses the severity of nine depressive symptoms in the last 7 days. Each item is rated on a 4-point scale (0-3), with total scores ranging from 0-27. Higher scores indicate more severe depression.

  Change from baseline depression symptoms severity at the final assessment

• Change in Transcranial Doppler ultrasound of Middle Cerebral Artery (MCA) blood flow velocity

  Middle Cerebral Artery (MCA) blood flow velocity will be measured under supine, resting conditions using non-invasive techniques following 10 min of quiet rest in a dimly lit room. It will be assessed in duplicate and averaged for analyses. Measurements will be taken from the left middle cerebral artery (MCA) following standardized, recommended insonation protocols using a 2-MHz Transcranial Doppler (TCD) probe secured to the temporal window via a headset. MCA mean blood velocity will be calculated using a standard algorithm implemented on the device, averaged over a 60-sec epoch.

  Change in baseline blood flow velocity at the final assessment

• Change in Transcranial Doppler ultrasound of Middle Cerebral Artery (MCA) blood flow pulsatility

  Middle Cerebral Artery (MCA) blood flow pulsatility will be measured under supine, resting conditions using non-invasive techniques following 10 min of quiet rest in a dimly lit room. It will be assessed in duplicate and averaged for analyses. Measurements will be taken from the left middle cerebral artery (MCA) following standardized, recommended insonation protocols using a 2-MHz Transcranial Doppler (TCD) probe secured to the temporal window via a headset. Cerebral pulsatility will be quantified using the pulsatility index, calculated as (systolic -diastolic velocity)/mean velocity using TCD, averaged over a 60-sec epoch.

  Change in baseline blood flow pulsatility at the final assessment

Secondary Outcomes (11)

• Columbia-Suicide Severity Rating Scale (CSSRS)

  Weeks 0, 8, 16, 26

• Estimated 1 Repetition Maximum (RM) Strength Test

  Weeks 0, 8, 16, 26

• Grip Strength

  Weeks 0, 8, 16, 26

• Arterial Stiffness

  Weeks 0, 8, 16, 26

• Carotid Structure

  Weeks 0, 8, 16, 26

Study Arms (1)

Resistance Exercise Training

EXPERIMENTAL

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

Behavioral: Resistance Exercise Training

Interventions

Resistance Exercise Training 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.

Resistance Exercise Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

Related Publications (1)

• Meyer JD, Perkins SL, Gidley JM, Kuzniar JM, Phillips LA, Lansing JL, Wade NG, Herring MP, Lefferts WK. Feasibility and preliminary efficacy of a theory-informed resistance exercise training single-arm intervention for major depression. Psychol Sport Exerc. 2024 Jul;73:102642. doi: 10.1016/j.psychsport.2024.102642. Epub 2024 Apr 12.

  PMID: 38615899 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Kinesiology

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 25, 2023
• Study Start: April 4, 2022
• Primary Completion: November 11, 2022
• Study Completion: January 10, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)