AgingM3AXNCT06507189
Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity in Older Adults (M3AX)
A study testing Combined endurance and resistance training in people with Aging and Aging Well, run by Florida Institute for Human and Machine Cognition at 2 sites in United States.
Trial summary
Aging-related functional declines are thought to be caused by hallmark biological processes that ultimately manifest in physical, mental, and metabolic impairments that compromise healthspan and quality of life. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Aging Well
- What is being tested?
- Combined endurance and resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 60 or above
- Free of chronic disease
- No structured exercise program (2 or more bouts/wk) within previous 12 months
- Cognitively capable of providing informed consent
Who cannot join
- Neuromuscular or musculoskeletal disorder that would limit ability to perform the exercise and/or testing bouts
- Cardiopulmonary disorders or reduced breathing capacity
- Metabolic diseases including markers of liver disease (ALT > 52 U/l) and type 2 diabetes (HbA1C = or > 6.5, fasting blood glucose = or > 126 mg/dl)
- Any other disease or disorder that would influence exercise response (e.g., chronic kidney disease, dementia, current cancer diagnosis or within 2 yr remission, cerebrovascular disease)
- Any current infectious disease
- Life expectancy < 1 year
Show all 13Show fewer
- Insulin sensitizing/blood glucose lowering agents such as metformin or metabolic weight loss agents (e.g. GLP-1 agonists)
- High dose statin (dose equivalent of 40 mg/d or higher simvastatin)
- Lidocaine allergy
- Regular tobacco use and/or vaping
- Excessive alcohol consumption (3 drinks/d or 7 drinks/wk for females; 4 drinks/d or 14 drinks/wk for males)
- BMI 35.0 kg/m2 or higher
- Unable to commit to ~6 months required to complete the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marcas Bamman, PHD contact
United States2 sites, 2 recruiting
- Recruiting
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Ben Miller, PHD, 405-271-7767, Benjamin-Miller@omrf.org
- Recruiting
Florida Institute for Human and Machine Cognition
Pensacola, Florida, 32502
Craig Tuggle, 205-352-6036, ctuggle@ihmc.org
About this study
Official title: Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity in Older Adults
Aging-related functional declines are thought to be caused by hallmark biological processes that ultimately manifest in physical, mental, and metabolic impairments that compromise healthspan and quality of life. Exercise is a multipotent treatment with promise to mitigate most aging hallmarks, but there is substantial variability in exercisƒe responsiveness. Combining endurance and resistance training in alignment with public health guidelines will be used to better understand variable exercise responsiveness in older adults with the ultimate goal of improving each older adult's capacity to attain the many health benefits of exercise.
Read the detailed description
Aging-related functional declines are thought to be caused by hallmark biological processes1 that ultimately manifest in physical, mental, and metabolic impairments - compromising healthspan and quality of life (QoL). Exercise is a multipotent treatment with promise to mitigate most aging hallmarks, but there is substantial variability in individual exercise responsiveness. This inter-individual response heterogeneity (IRH) was first identified and extensively interrogated by Bouchard and colleagues in the context of endurance training (ET). Subsequently, the investigators have demonstrated resistance training (RT) IRH and have studied potential IRH mechanisms. The investigators then led multiple trials in older adults examining dose titration, adjuvant nutrition or medication in attempts to lower poor response rates. Many knowledge gaps remain as summarized in the National Institutes of Aging (NIA) workshop on IRH seeding this Requests for Applications (RFA). The investigators have assembled an interdisciplinary team to address the RFA's central goal, "to better understand factors underlying response variability to exercise training in older adults." Although Health and Human Services (HHS) guidelines specify combined ET and RT to maximize health benefits in aging adults, large-scale exercise trials studying IRH (i.e., HERITAGE, MoTrPAC) have restricted participants to a single exercise mode. For this project, the investigators propose the innovative, but logical, strategy to use combined ET and RT. Low cardiorespiratory fitness (CRF, VO2max) and low functional muscle quality (fMQ; strength/muscle mass) are multi-system manifestations of the deterioration of the cellular hallmarks of aging. Importantly, both CRF and fMQ are modifiable with ET and RT. Thus, the investigators design premise is that combined ET+RT is an excellent strategy for elucidating factors underlying IRH, as it forges a path toward understanding and mitigating IRH in aging with direct translatability to best-evidence public health recommendations.
It is yet to be determined how the hallmarks of aging interact to influence exercise responsiveness. For example, muscle mitochondrial energetics and proteostasis are inextricably linked, and poor responder status may be caused by lack of energetic resources to maintain proteostasis throughout an exercise program. Similarly, aging disrupts circadian clocks, leading to inflammation and disrupted cell signaling, which may also contribute to IRH.
While sources of IRH are a constellation of modifiable and non-modifiable factors, the investigators will test the hypothesis that factors central to aging itself - aging hallmarks such as proteostasis, mitochondrial energetics, and inflammation, as well as systemic and muscle-specific circadian clock function and output - are chief contributors to the multidimensional circuitry that determines whether an individual achieves the minimum clinically important difference (MCID) in CRF and/or fMQ with exercise training. The investigators will also test the hypothesis that altered exercise dosing coupled with lifestyle recommendations will promote attainment of MCIDs among older adults who do not initially respond. With CRF and fMQ as primary clinical outcomes, the investigators will use a 2-phase Sequential Multiple Assignment Randomized Trial (SMART) of combined ET+RT with clinical phenotyping and blood/muscle molecular and cellular analyses.
- Conditions
- Aging, Aging Well
- Being tested
- Combined endurance and resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined endurance and resistance trainingOther
ET will consist of 3x/wk training (MWF) with MF being steady state cycling, treadmill, or elliptical at 70-75% HRR for 30 min and the W session being a 20 min high intensity interval session on a cycle ergometer (1 min on/off; 10 cycles) targeting 85-90% HRR. The treadmill and elliptical on M or F will be provided for variety but the mainstay will be cycle ergometry. On MF participants will complete 3 sets x 8-12 repetitions for leg press, knee extension, hamstring curl, chest press, seated row, overhead press, lat pulldown, triceps push-down, and biceps curl in superset fashion [i.e., alternate between opposing muscle groups without rest (chest press followed by seated row)] with a 60 s rest between supersets. Sets will be performed with load progression to ensure volitional fatigue in the 8-12 rep range. Core exercises (trunk flexion and extension) will also be included using bodyweight only for 3 sets.
| Study group | Role | What they receive |
|---|---|---|
| Phase I (12 weeks) | Experimental | In Interrogation, all participants will exercise train using an exercise prescription that is in accordance with current public health recommendations. At the end of Phase I participants will be classified into one of four categories: (1) CRF-/fMQ-, 2) CRF-/fMQ+, 3) CRF+/fMQ- and 4) CRF+/fMQ+). Receives: Other: Combined endurance and resistance training |
| Phase II (10 weeks) | Experimental | Based on the Phase I categories of responsiveness, exercise training will be boosted in the three groups that are non-responsive in one or both outcomes. CRF-/fMQ+ will receive boosted ET, CRF+/fMQ- will receive boosted RT, and CRF-/fMQ- will receive boosting in both. All three of these classifications will also receive education on wearable device data and other free-living recommendations. Participants classified as CRF+/fMQ+ at the end of Phase I will be randomized to either continue the supervised exercise training or to free-living. Receives: Other: Combined endurance and resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness (CRF)
A primary outcome of this investigation is cardiorespiratory fitness (CRF). The CRF is the amount of oxygen (ml/kg) that is used during exercise and how efficient you are using that oxygen. The exercise used to measure oxygen uptake is a stationary bicycle with increasing intensity until you are able to maintain pace. Your expired air is collected with a mask or mouthpiece and analyzed with an oxygen and carbon dioxide sensor.
Measured: 23 weeks
Functional muscle quality (fMQ)
A primary outcome of this investigation is functional muscle quality (fMQ). This is a ratio of knee extension strength to thigh leanness. Knee extension strength is the maximum amount of weight you can successfully lift one time. Thigh lean mass is measured with the dual energy x-ray absorptiometry (DEXA). This is a common tool used to measure bone density, but it is very efficient at determining fat and lean masses partitioned in the body.
Measured: 23 weeks
Secondary outcomes (5)
Balance
Balance will be assessed with tools such at the short physical performance battery (SPPB). The SPPB is a clinical test used to measure balance in three areas of balance: stand-in balance, gait speed and chair stand time. The overall higher score you have is an indicator of better balance.
Measured: 23 weeks
Cognitive performance
An assessment such as the Trail Making Task (TMT)is used to measure reaction times at the beginning of and after the exercise intervention.
Measured: 23 weeks
Body composition
Body composition will be measured four times pre and post to exercise intervention.
Measured: 23 weeks
Metabolic health
A clinical assessment such as continuous glucose monitoring (CGM) will be use to measure metabolic health at the beginning, the middle, and end of intervention time points. CGM will monitored for seven days pre and post to the exercise intervention. This can be used to determine blood glucose response before and after exercise.
Measured: 23 weeks
Metabolic health
The HOMA-IR will is test used to determine protein turn over or how efficient you are at processing proteins.
Measured: 23 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start27 Jan 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Randomised
- Intervention model
- Factorial
- Model description
- The overarching goal of this project is to determine factors contributing to response heterogeneity in outcomes key to healthy aging. The first phase of this two-phase trial will be focused on understanding the underlying biological mechanisms that explain/predict response heterogeneity and the second phase will test augmentation efforts to mitigate poor responsiveness while assessing whether the same or different mechanisms predict response when augmenting an individual's prescription in Phase II.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Institute for Human and Machine Cognition
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, Oklahoma Medical Research Foundation
- Responsible party
- Sponsor
- Investigators
- Marcas Bamman, Principal investigator, Florida Institute for Human and Machine Cognition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507189
- Sponsor's protocol ID
- IRB-2024-0083
- Acronym
- M3AX
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Entry and Management System. Regarding the data entry and management system (DEMS) used for data management, we will customize one of the DEMS platforms developed by the team at IHMC using Smartabase, which is a federally approved, secure cloud-based environment we are currently using in other federally funded observational studies and clinical trials. We have experienced Smartabase builders on the team led by Dr. McAdam who will create custom programs and forms for the study that facilitate data collection and entry while also having the infrastructure to provide access to real-time data summaries and comparisons across all performance sites. Importantly, we have established numerous streamlined approaches for direct electronic data transfer to Smartabase from testing instruments (e.g., DXA, metabolic carts, strength dynamometers, EMG systems) via APIs to eliminate manual data entry errors.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity in Older Adults
- ClinicalTrials.gov ID
- NCT06507189
- Acronym / sponsor ID
- M3AX / IRB-2024-0083
- Conditions
- Aging, Aging Well
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Florida Institute for Human and Machine CognitionUniversity, hospital or other
- Collaborators
- University of Florida, Oklahoma Medical Research Foundation
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 18 Jul 2024 (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.
Aging-related functional declines are thought to be caused by hallmark biological processes that ultimately manifest in physical, mental, and metabolic impairments that compromise healthspan and quality of life. Exercise is a multipotent treatment with promise to mitigate most aging hallmarks, but there is substantial variability in exercisƒe responsiveness. Combining endurance and resistance training in alignment with public health guidelines will be used to better understand variable exercise responsiveness in older adults with the ultimate goal of improving each older adult's capacity to attain the many health benefits of exercise.
Detailed description
Aging-related functional declines are thought to be caused by hallmark biological processes1 that ultimately manifest in physical, mental, and metabolic impairments - compromising healthspan and quality of life (QoL). Exercise is a multipotent treatment with promise to mitigate most aging hallmarks, but there is substantial variability in individual exercise responsiveness. This inter-individual response heterogeneity (IRH) was first identified and extensively interrogated by Bouchard and colleagues in the context of endurance training (ET). Subsequently, the investigators have demonstrated resistance training (RT) IRH and have studied potential IRH mechanisms. The investigators then led multiple trials in older adults examining dose titration, adjuvant nutrition or medication in attempts to lower poor response rates. Many knowledge gaps remain as summarized in the National Institutes of Aging (NIA) workshop on IRH seeding this Requests for Applications (RFA). The investigators have assembled an interdisciplinary team to address the RFA's central goal, "to better understand factors underlying response variability to exercise training in older adults." Although Health and Human Services (HHS) guidelines specify combined ET and RT to maximize health benefits in aging adults, large-scale exercise trials studying IRH (i.e., HERITAGE, MoTrPAC) have restricted participants to a single exercise mode. For this project, the investigators propose the innovative, but logical, strategy to use combined ET and RT. Low cardiorespiratory fitness (CRF, VO2max) and low functional muscle quality (fMQ; strength/muscle mass) are multi-system manifestations of the deterioration of the cellular hallmarks of aging. Importantly, both CRF and fMQ are modifiable with ET and RT. Thus, the investigators design premise is that combined ET+RT is an excellent strategy for elucidating factors underlying IRH, as it forges a path toward understanding and mitigating IRH in aging with direct translatability to best-evidence public health recommendations.
It is yet to be determined how the hallmarks of aging interact to influence exercise responsiveness. For example, muscle mitochondrial energetics and proteostasis are inextricably linked, and poor responder status may be caused by lack of energetic resources to maintain proteostasis throughout an exercise program. Similarly, aging disrupts circadian clocks, leading to inflammation and disrupted cell signaling, which may also contribute to IRH.
While sources of IRH are a constellation of modifiable and non-modifiable factors, the investigators will test the hypothesis that factors central to aging itself - aging hallmarks such as proteostasis, mitochondrial energetics, and inflammation, as well as systemic and muscle-specific circadian clock function and output - are chief contributors to the multidimensional circuitry that determines whether an individual achieves the minimum clinically important difference (MCID) in CRF and/or fMQ with exercise training. The investigators will also test the hypothesis that altered exercise dosing coupled with lifestyle recommendations will promote attainment of MCIDs among older adults who do not initially respond. With CRF and fMQ as primary clinical outcomes, the investigators will use a 2-phase Sequential Multiple Assignment Randomized Trial (SMART) of combined ET+RT with clinical phenotyping and blood/muscle molecular and cellular analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The overarching goal of this project is to determine factors contributing to response heterogeneity in outcomes key to healthy aging. The first phase of this two-phase trial will be focused on understanding the underlying biological mechanisms that explain/predict response heterogeneity and the second phase will test augmentation efforts to mitigate poor responsiveness while assessing whether the same or different mechanisms predict response when augmenting an individual's prescription in Phase II.
| Arm | Type | Receives |
|---|---|---|
| Phase I (12 weeks) | Experimental | Other: Combined endurance and resistance trainingIn Interrogation, all participants will exercise train using an exercise prescription that is in accordance with current public health recommendations. At the end of Phase I participants will be classified into one of four categories: (1) CRF-/fMQ-, 2) CRF-/fMQ+, 3) CRF+/fMQ- and 4) CRF+/fMQ+). |
| Phase II (10 weeks) | Experimental | Other: Combined endurance and resistance trainingBased on the Phase I categories of responsiveness, exercise training will be boosted in the three groups that are non-responsive in one or both outcomes. CRF-/fMQ+ will receive boosted ET, CRF+/fMQ- will receive boosted RT, and CRF-/fMQ- will receive boosting in both. All three of these classifications will also receive education on wearable device data and other free-living recommendations. Participants classified as CRF+/fMQ+ at the end of Phase I will be randomized to either continue the supervised exercise training or to free-living. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 60 or above
- Free of chronic disease
- No structured exercise program (2 or more bouts/wk) within previous 12 months
- Cognitively capable of providing informed consent
Key exclusion criteria (13 listed)
- Neuromuscular or musculoskeletal disorder that would limit ability to perform the exercise and/or testing bouts
- Cardiopulmonary disorders or reduced breathing capacity
- Metabolic diseases including markers of liver disease (ALT > 52 U/l) and type 2 diabetes (HbA1C = or > 6.5, fasting blood glucose = or > 126 mg/dl)
- Any other disease or disorder that would influence exercise response (e.g., chronic kidney disease, dementia, current cancer diagnosis or within 2 yr remission, cerebrovascular disease)
- Any current infectious disease
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 |
|---|---|---|
| Combined endurance and resistance trainingET will consist of 3x/wk training (MWF) with MF being steady state cycling, treadmill, or elliptical at 70-75% HRR for 30 min and the W session being a 20 min high intensity interval session on a cycle ergometer (1 min on/off; 10 cycles) targeting 85-90% HRR. The treadmill and elliptical on M or F will be provided for variety but the mainstay will be cycle ergometry. On MF participants will complete 3 sets x 8-12 repetitions for leg press, knee extension, hamstring curl, chest press, seated row, overhead press, lat pulldown, triceps push-down, and biceps curl in superset fashion [i.e., alternate between opposing muscle groups without rest (chest press followed by seated row)] with a 60 s rest between supersets. Sets will be performed with load progression to ensure volitional fatigue in the 8-12 rep range. Core exercises (trunk flexion and extension) will also be included using bodyweight only for 3 sets. | Other | Phase I (12 weeks), Phase II (10 weeks) |
Primary outcome
Cardiorespiratory fitness (CRF)
Time frame: 23 weeks
A primary outcome of this investigation is cardiorespiratory fitness (CRF). The CRF is the amount of oxygen (ml/kg) that is used during exercise and how efficient you are using that oxygen. The exercise used to measure oxygen uptake is a stationary bicycle with increasing intensity until you are able to maintain pace. Your expired air is collected with a mask or mouthpiece and analyzed with an oxygen and carbon dioxide sensor.
Functional muscle quality (fMQ)
Time frame: 23 weeks
A primary outcome of this investigation is functional muscle quality (fMQ). This is a ratio of knee extension strength to thigh leanness. Knee extension strength is the maximum amount of weight you can successfully lift one time. Thigh lean mass is measured with the dual energy x-ray absorptiometry (DEXA). This is a common tool used to measure bone density, but it is very efficient at determining fat and lean masses partitioned in the body.
5 secondary outcomes
Balance
Time frame: 23 weeks
Cognitive performance
Time frame: 23 weeks
Body composition
Time frame: 23 weeks
Metabolic health
Time frame: 23 weeks
Metabolic health
Time frame: 23 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. Data Entry and Management System. Regarding the data entry and management system (DEMS) used for data management, we will customize one of the DEMS platforms developed by the team at IHMC using Smartabase, which is a federally approved, secure cloud-based environment we are currently using in other federally funded observational studies and clinical trials. We have experienced Smartabase builders on the team led by Dr. McAdam who will create custom programs and forms for the study that facilitate data collection and entry while also having the infrastructure to provide access to real-time data summaries and comparisons across all performance sites. Importantly, we have established numerous streamlined approaches for direct electronic data transfer to Smartabase from testing instruments (e.g., DXA, metabolic carts, strength dynamometers, EMG systems) via APIs to eliminate manual data entry errors.
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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.
Marcas Bamman, PHD contact
Marcas Bamman principal investigator
Florida Institute for Human and Machine Cognition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined endurance and resistance training in people with Aging and Aging Well, run by Florida Institute for Human and Machine Cognition at 2 sites 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Craig Tuggle (205-352-6036, ctuggle@ihmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (CRF) (time frame: 23 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.