Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity in Older Adults (M3AX)

Part of paid clinical trials in Pensacola, Florida.

Sponsor
Florida Institute for Human and Machine Cognition
Study ID
NCT06507189
Status
Recruiting
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Conditions

  • Aging
  • Aging Well

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Combined endurance and resistance training — OTHER
    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 Details

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.

Key Dates

Start date
Jan 27, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I (12 weeks)
    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+).
  • Experimental: Phase II (10 weeks)
    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.

Primary Outcome Measure

Cardiorespiratory fitness (CRF) [ Time Frame: 23 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Florida Institute for Human and Machine CognitionPensacolaFlorida32502
Craig Tuggle
[email protected]
205-352-6036
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104
Ben Miller, PHD
[email protected]
405-271-7767

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By research site
Florida Institute for Human and Machine Cognition· Pensacola, FLOklahoma Medical Research Foundation· Oklahoma City, OK

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