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Behavioral Intervention

Resistance Exercise for Depression (RESIST Trial)

N/A

Recruiting

Research Sponsored by Iowa State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be ages 18-65

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 0, 8, 16, 26, 52 (worn 1 week following week 0 and 1 week after all other timepoints)

Awards & highlights

RESIST Trial Summary

This trial will investigate how exercise can help treat depression in 200 adults, to see if it can be more effective than current treatments. #Depression #Exercise #Treatment

Who is the study for?

Adults aged 18-65 with Major Depressive Disorder as confirmed by a clinical interview, who have mild to severe depressive symptoms. Participants should either not be on mental health treatments or be on a stable regimen for at least 8 weeks and willing to maintain it. They must be safe to exercise per doctor's approval and cannot currently meet the resistance exercise recommendations, be pregnant, or have certain other mental health disorders.Check my eligibility

What is being tested?

The trial is testing how effective two different doses of resistance exercise training are in treating depression over a period of 16 weeks. It will compare the outcomes between a group doing low dose exercises against another doing high dose exercises.See study design

What are the potential side effects?

While this trial involves physical exercise which typically has benefits for health, potential side effects may include muscle soreness, fatigue, joint pain or injury due to activity. The intensity of these side effects could vary based on individual fitness levels.

RESIST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I am currently experiencing mild or more severe depression.

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I have been diagnosed with major depression.

RESIST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 8, 16, 26, 52 (worn 1 week following week 0 and 1 week after all other timepoints)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 0, 8, 16, 26, 52 (worn 1 week following week 0 and 1 week after all other timepoints)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 8, 16, 26, 52 (worn 1 week following week 0 and 1 week after all other timepoints) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cerebral blood velocity pulsatility

Cerebral mean blood velocity

Change in depressive symptom severity measured by GRID Hamilton Depression Rating Scale (GRID-HAM-D)

+1 more

Secondary outcome measures

Aortic stiffness

Average self-reported level of symptom improvement measured by Patient Global Impression of Change (PGIC)

Blood Pressure Variability (BPV)

+22 more

Other outcome measures

Major depressive disorder diagnosis assessed using Structured Clinical Interview for DSM-5 Disorders (SCID)

RESIST Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High Dose Resistance Exercise TrainingExperimental Treatment1 Intervention

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.

Group II: Low Dose Resistance Exercise TrainingActive Control1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,499 Total Patients Enrolled

667 Trials studying Depression

251,584 Patients Enrolled for Depression

Iowa State UniversityLead Sponsor

59 Previous Clinical Trials

144,353 Total Patients Enrolled

1 Trials studying Depression

40 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially become a participant in this trial?

"This clinical trial is currently enrolling approximately 200 participants, all of whom must be suffering from depression and have an age range between 18 to 65."

Answered by AI

Is this study recruiting geriatric participants?

"This medical trial has an age requirement of 18 to 65 years old, but there are other studies available for younger and older patients. Specifically, 120 trials are specifically tailored towards those under the age of 18 while 637 clinical trials have been created with seniors in mind."

Answered by AI

Are there still available slots for patients to take part in this research?

"No, this trial is not currently enrolling participants. Initially posted on January 1st 2024 and last updated October 25th 2023, no new patients are being admitted at present; though 884 other clinical trials require enrolment."

Answered by AI

What is the primary aim of this experiment?

"The focus of this clinical trial, which will be quantified over the Weeks 0, 8, 16, 26 and 52 time frame is to gage any variation in self-reported depression symptom severity through the Quick Inventory of Depressive Symptoms (QIDS). Secondary goals include noting changes in RET-specific self efficacy using a modified version of the New General Self Efficacy Scale; assessing suicidal thoughts with Columbia-Suicide Severity Rating Scale (CSSRS); and measuring muscular strength via Estimated 1 Repetition Maximum Strength Test."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RESISTance Exercise for Depression Trial

Jacob Meyer 2024. "RESISTance Exercise for Depression Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06110897.