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

ConditionsAgingAging Well
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorFlorida Institute for Human and Machine Cognition

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Factorial

Treatments tested in this trial

  • Combined endurance and resistance training

    Other intervention

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Phase I (12 weeks)Experimental treatment 1 intervention
Group B: Phase II (10 weeks)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
23 weeks
2

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.

Time frame
23 weeks

Secondary outcomes

1

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.

Time frame
23 weeks
2

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.

Time frame
23 weeks
3

Body composition

Body composition will be measured four times pre and post to exercise intervention.

Time frame
23 weeks
4

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.

Time frame
23 weeks

Other outcomes

Sponsors and contacts

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Florida Institute for Human and Machine Cognition

Lead sponsor

University of Florida

Collaborator

Oklahoma Medical Research Foundation

Collaborator