Major Depressive DisorderNCT05695365
Feasibility of Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms
A study testing Resistance Exercise Training in people with Major Depressive Disorder, run by Iowa State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Resistance Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms: A Pilot Trial
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Resistance Exercise Training
- Keywords
- Resistance Exercise
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise Training | Experimental | Participants will complete a 16-week, twice/week program to increase strength. Receives: Behavioral: Resistance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 26
Retention (acceptability)
The retention rate will be calculated based on the percentage of participants that complete all study visits.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in baseline blood flow pulsatility at the final assessment
Secondary outcomes (11)
Columbia-Suicide Severity Rating Scale (CSSRS)
This is a clinician-administered questionnaire regarding suicidal ideation and behavior. The severity of the ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with a plan. Suicide behavior is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal, self-injurious behavior.
Measured: Weeks 0, 8, 16, 26
Estimated 1 Repetition Maximum (RM) Strength Test
A 5-RM testing method will be used to calculate each participant's estimated 1-RM, in which participants will lift the maximum amount of weight that can be lifted five times with correct form, timing, and breathing. Maximum strength will be assessed on one upper body (chest press) and one lower body (leg press) major muscle group, completed using the Keiser resistance machines.
Measured: Weeks 0, 8, 16, 26
Grip Strength
A research assistant will ask the participant to sit in a chair and rest his/her arm on the table with the elbow on top of a mouse pad and arm held at a right angle to adjust the dynamometer to the participant's hand size. The participant will then squeeze the dynamometer twice to practice. To begin the assessment, the participant will use his/her right hand and squeeze as hard as possible. Three trials will be attempted with each hand. When the right hand is complete, the left hand will be assessed (i.e., 3 trials). A sum of the greatest effort (number) for each hand is totaled (rounded to the nearest 2 kilograms) and will be recorded.
Measured: Weeks 0, 8, 16, 26
Arterial Stiffness
Aortic stiffness will be assessed via carotid-femoral pulse wave velocity (CfPWV). Carotid and femoral pressure waveforms will be captured with applanation tonometry and simultaneous R-wave gating. CfPWV will be calculated as the distance between carotid and femoral sites divided by the time lag (Δt) between carotid-femoral waves.
Measured: Weeks 0, 8, 16, 26
Carotid Structure
The carotid structure will be assessed by measuring diameter, wall thickness, and stiffness using ultrasound and carotid pressures obtained from contralateral carotid tonometry during CfPWV assessment. WV-β will be calculated using onboard wall-tracking software to determine common carotid stiffness and diameter. Carotid wall thickness (IMT) will be measured using semi-automated calipers.
Measured: Weeks 0, 8, 16, 26
International Physical Activity Questionnaire Short Form
The International Physical Activity Questionnaire Short Form (IPAQ-SF) is a measure that assesses the types of the intensity of physical activity and sitting time that people did over the past 7 days using seven questions via self-report by the participant. Participants are instructed to report the number of days per week and minutes per day they spend engaging in 1) vigorous activity, 2) moderate activity, 3) walking, and 4) sitting. Responses are used to calculate total minutes of walking, minutes of moderate-to-vigorous physical activity per week, and hours of sitting time on a weekday and weekend day, with higher scores indicating greater levels of each behavior.
Measured: Weeks 0, 8, 16, 26
activPAL (sedentary time and MVPA)
Participants will place an activPAL on the midline of the thigh on either leg and wear the monitor 24 hours per day, removing it only for water-based activities (e.g., swimming). For data to be valid, the monitor must have been worn for 20 hours on at least 4 days, including a minimum of 3 weekdays and 1 weekend day. Sleep time will be parsed out from each day's sitting/lying time automatically using PALanalysis. From these data, average minutes of sitting per day will be used to assess total sedentary time, minutes of stepping time with a cadence ≥75 and <100 will be used to assess minutes of light intensity physical activity, and minutes of stepping time with a cadence ≥100 will be used to assess minutes of moderate to vigorous physical activity (MVPA).
Measured: Monitors worn for 7 days following week 0 (intake assessment) and 7 days prior to week 8 and 16 assessments
36-Item Short Form Health Survey (SF-36)
The SF-36 assesses health-related qualify of life. It consists of eight scaled scores (including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability).
Measured: Weeks 0, 8, 16, 26
Penn State Worry Questionnaire (PSWQ)
The Penn State Worry Questionnaire (PSWQ) is a 16-item questionnaire that assesses the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me). The total scores range from 16 to 80 with higher scores indicating greater levels of worry.
Measured: Weeks 0, 8, 16, 26
Perceived Stress Scale (PSS-10)
This is a 10-item questionnaire to measure an individual's level of perceived stress in the past month. The response options for each feeling or thought indicate the frequency with which it occurred: 0 = Never; 1 = Almost Never; 2 = Sometimes; 3 = Fairly Often; 4 = Very Often.
Measured: Weeks 0, 8, 16, 26
Exercise Identity Scale (EIS)
The EIS is a 9-item questionnaire used to assess the salience of identifying with exercise as an integral portion of the self-concept. Participants respond to each EIS item on a scale, anchored by (1) Strongly Disagree and (7) Strongly Agree, after reading a stem that contextualized each item within their personal exercise experiences (e.g., "The following questions concern your personal beliefs about exercise. Please indicate the degree to which you agree or disagree with each statement when thinking about your exercise participation."). Higher scores reflect greater feelings of exercise as an integral part of their self-identity.
Measured: Weeks 0, 8, 16, 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start4 Apr 2022
- Primary completion11 Nov 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Meyer, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695365
- Sponsor's protocol ID
- 21-452
- Status last verified
- Mar 2024
- First submitted
- 14 Dec 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no known plans for future use.
Publications
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.
PubMed 38615899
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms: A Pilot Trial
- ClinicalTrials.gov ID
- NCT05695365
- Acronym / sponsor ID
- 21-452
- Conditions
- Major Depressive Disorder
- Keywords
- Resistance Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Training | Experimental | Behavioral: Resistance Exercise TrainingParticipants will complete a 16-week, twice/week program to increase strength. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise TrainingParticipants 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. | Behavioural | Resistance Exercise Training |
Primary outcome
Recruitment and enrollment rates (feasibility)
Time frame: Week 26
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.
Participant satisfaction (acceptability)
Time frame: Week 26
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.
Retention (acceptability)
Time frame: Week 26
The retention rate will be calculated based on the percentage of participants that complete all study visits.
Adherence (acceptability)
Time frame: Week 26
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.
Change in exercise preparation habit ratings
Time frame: Change from week 1 habit ratings at week 16
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 in level of commitment
Time frame: Change from week 1 level of commitment at week 16
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 in depression symptom severity via GRID-Hamilton Depression Rating Scale (HAM-D)
Time frame: Change from baseline depression severity at the final assessment
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 in depression diagnosis via Structured Clinical Interview for DSM-5 Disorders (SCID)
Time frame: Change from baseline depression diagnosis at the final assessment
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 in depressive symptoms severity via the Quick Inventory of Depressive Symptoms (QIDS)
Time frame: Change from baseline depression symptoms severity at the final assessment
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 in Transcranial Doppler ultrasound of Middle Cerebral Artery (MCA) blood flow velocity
Time frame: Change in baseline blood flow velocity at the final assessment
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 Transcranial Doppler ultrasound of Middle Cerebral Artery (MCA) blood flow pulsatility
Time frame: Change in baseline blood flow pulsatility at the final assessment
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.
11 secondary outcomes
Columbia-Suicide Severity Rating Scale (CSSRS)
Time frame: Weeks 0, 8, 16, 26
Estimated 1 Repetition Maximum (RM) Strength Test
Time frame: Weeks 0, 8, 16, 26
Grip Strength
Time frame: Weeks 0, 8, 16, 26
Arterial Stiffness
Time frame: Weeks 0, 8, 16, 26
Carotid Structure
Time frame: Weeks 0, 8, 16, 26
International Physical Activity Questionnaire Short Form
Time frame: Weeks 0, 8, 16, 26
activPAL (sedentary time and MVPA)
Time frame: Monitors worn for 7 days following week 0 (intake assessment) and 7 days prior to week 8 and 16 assessments
36-Item Short Form Health Survey (SF-36)
Time frame: Weeks 0, 8, 16, 26
Penn State Worry Questionnaire (PSWQ)
Time frame: Weeks 0, 8, 16, 26
Perceived Stress Scale (PSS-10)
Time frame: Weeks 0, 8, 16, 26
Exercise Identity Scale (EIS)
Time frame: Weeks 0, 8, 16, 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 38615899Meyer 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.
- Individual participant dataSharing planned: No. There are no known plans for future use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Training in people with Major Depressive Disorder, run by Iowa State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and enrollment rates (feasibility) (time frame: Week 26). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05695365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.