Recruiting

Exercise

Sponsor:

Florida Institute for Human and Machine Cognition

Code:

NCT06507189

Conditions

Aging

Aging Well

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Combined endurance and resistance training

Study Details

Brief 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. 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.

Conditions

Aging

Aging Well

Study ID

NCT06507189

Start date

Jan 27, 2025

Status verified date

Apr, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Male or female aged 60 or above
2. Free of chronic disease
3. No structured exercise program (2 or more bouts/wk) within previous 12 months
4. Cognitively capable of providing informed consent

Exclusion Criteria:

1. Neuromuscular or musculoskeletal disorder that would limit ability to perform the exercise and/or testing bouts
2. Cardiopulmonary disorders or reduced breathing capacity
3. 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)
4. 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)
5. Any current infectious disease
6. Life expectancy < 1 year
7. Insulin sensitizing/blood glucose lowering agents such as metformin or metabolic weight loss agents (e.g. GLP-1 agonists)
8. High dose statin (dose equivalent of 40 mg/d or higher simvastatin)
9. Lidocaine allergy
10. Regular tobacco use and/or vaping
11. Excessive alcohol consumption (3 drinks/d or 7 drinks/wk for females; 4 drinks/d or 14 drinks/wk for males)
12. BMI 35.0 kg/m2 or higher
13. Unable to commit to \~6 months required to complete the study

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Combined endurance and resistance training

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.

Primary outcome measure

  • Cardiorespiratory fitness (CRF) [ Time Frame: 23 weeks ]
  • Functional muscle quality (fMQ) [ Time Frame: 23 weeks ]

Central Contacts and Locations

Central contacts

Craig Tuggle

205-352-6036ctuggle@ihmc.org

Marcas Bamman, PHD

mbamman@ihmc.org

Locations

Florida Institute for Human and Machine Cognition

Recruiting

Pensacola, Florida, United States, 32502

Contacts

Craig Tuggle

205-352-6036ctuggle@ihmc.org

Oklahoma Medical Research Foundation

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Ben Miller, PHD

405-271-7767Benjamin-Miller@omrf.org

More Information

Sponsor

Florida Institute for Human and Machine Cognition

Last update posted

Aug 10, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida Institute for Human and Machine Cognition on 2026-08-10.