Exercise for Healthy Aging

(COMET Trial)

Overseen By Amanda Szabo-Reed, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Insulin

Disqualifiers: Heart disease, Schizophrenia, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of exercise can benefit brain function in older adults. Researchers aim to determine if regular physical activity, such as weight training or brisk walking, can enhance cognitive health. Participants will follow one of four exercise plans, ranging from weight training to endurance exercises. This trial suits individuals aged 65 to 80 who can exercise without severe joint pain or mobility issues and have normal cognitive function. As an unphased trial, it offers participants the chance to contribute to valuable research on exercise and cognitive health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have changed your blood pressure medication in the last 2 months or if you are currently taking insulin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that weight training programs are safe for healthy older adults when performed correctly and with guidance. Research also shows that core exercises improve balance and stability in older adults, making them a safe and beneficial choice.

For a mix of endurance and weight training, studies have found that older adults can safely engage in these exercises, leading to improved fitness and reduced health risks. Endurance activities, such as brisk walking, are known to be safe and beneficial for heart health and managing long-term health issues in older adults.

Overall, these exercise programs are generally well-tolerated, with no major problems reported when guidelines are followed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different exercise regimens to promote healthy aging, which could offer more personalized and effective options compared to traditional recommendations like general aerobic or resistance training. The trial is unique in that it examines varied combinations of weight training, endurance training, and Core and Fusion exercises, each targeting specific fitness components such as strength, cardiovascular endurance, flexibility, and balance. These tailored exercise programs could potentially enhance overall physical function and quality of life in older adults more efficiently than existing single-focus exercise routines. By understanding the distinct benefits of each regimen, researchers aim to identify optimal exercise strategies for aging populations.

What evidence suggests that this trial's exercise treatments could be effective for healthy aging?

Research has shown that exercise greatly benefits older adults, particularly by enhancing physical and mental abilities. In this trial, participants will follow different exercise regimens. One group will engage in weight training, which strengthens muscles and improves the coordination of nerves and muscles, aiding in everyday tasks. Another group will perform core and fusion exercises, known to enhance balance, crucial for preventing falls. A third group will combine endurance and weight training, which can boost overall fitness for individuals over 50. Lastly, some participants will focus solely on endurance exercises, which improve heart health and reduce the risk of early mortality. Each exercise type in this trial supports healthy aging. ^{1 6 7 8 9}

Who Is on the Research Team?

Eric D Vidoni, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for people aged 65-80 with good cognitive health, confirmed by a medical monitor. Participants must speak and read English, have their own transport, and be medically cleared to exercise. Excluded are those using walking aids, on insulin or certain heart medications, with recent serious health issues like heart attacks or untreated atrial fibrillation, or planning extensive travel.

Inclusion Criteria

I have a reliable way to get to my appointments.

Conversant English speaking and reading ability.

I am between 65 and 80 years old.

Exclusion Criteria

I do not have a major psychiatric illness or condition affecting my brain that could impact thinking tests.

I haven't changed my blood pressure medication in the last 2 months.

You have received treatment for alcohol or drug abuse within the past two years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 26-week exercise intervention to test the effects of aerobic and resistance training on cognition, brain structure, and physical function

26 weeks

Regular visits for exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Assessments at 6 months and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study investigates the benefits of recommended public health exercises on cognitive function in older adults. It aims to encourage active lifestyles among seniors and inform effective exercise programs that support both physical and mental well-being.

How Is the Trial Designed?

Group I: Weight Training Active Control 1 Intervention

Progressive resistance training 2 days/week, non-consecutive, of 2 sets (10 - 15 repetitions) of 10 exercises (\~75 minutes/week). Progression based on repetition completion and 1-repetition maximum. In addition 3 days of Core and Fusion control exercise will also be recommended.

Group II: Core and Fusion Training Active Control 1 Intervention

150 minutes/week of Core and Fusion exercise, a mix of low impact toning, strengthening, flexibility and balance exercises.

Group III: Combined Endurance and Weight Training Active Control 1 Intervention

Moderate-intensity endurance training such as brisk walking, 150 minutes/week over 3-5 days. Progression based on a set schedule. Progressive resistance training 2 days/week, non-consecutive, of 2 sets (10 - 15 repetitions) of 10 exercises (\~75 minutes/week). Progression based on repetition completion and 1-repetition maximum.

Group IV: Endurance Training Active Control 1 Intervention

Moderate-intensity endurance training such as brisk walking, 150 minutes/week over 3-5 days. Progression based on a set schedule. In addition 0-2 days of Core and Fusion control exercise will also be recommended.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

Vigorous physical activity can increase the risk of cardiovascular and musculoskeletal complications, especially in sedentary individuals with pre-existing heart conditions, with relative risks of exercise-related cardiac events ranging from 2.1 to 56.

While exercise is generally beneficial for heart health, there is a potential for both underdosing and overdosing, suggesting that there is an optimal level of exercise beyond which the risks may outweigh the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting the benefits and risks of aerobic exercise in perspective. Franklin, BA., Billecke, S.[2022]

Biologic aging is influenced by both genetic factors and environmental exposures, with physical inactivity being a significant modifiable risk factor that can be addressed through exercise.

Research shows that even frail elders with chronic diseases can experience beneficial adaptations to exercise, highlighting the need for effective exercise prescriptions and tailored programs to encourage physical activity among inactive populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and aging. Singh, MA.[2022]

Regular exercise is crucial for healthy aging, helping to prevent issues like falls, pain, and cognitive decline, yet most older adults do not meet the recommended activity levels.

Healthcare provider counseling and community-based exercise programs can significantly support older adults in improving their physical activity habits, enhancing their overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Healthy Aging. Eckstrom, E., Neukam, S., Kalin, L., et al.[2021]

Resistance training (RT) significantly reduces all-cause mortality and the incidence of cardiovascular disease while improving physical functioning in adults, based on an analysis of 11 systematic reviews involving over 382,000 participants.

Although adverse events were not consistently reported, serious adverse events related to RT were uncommon, suggesting that the benefits of resistance training outweigh the potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. El-Kotob, R., Ponzano, M., Chaput, JP., et al.[2021]

Improving physical fitness through exercise significantly reduces the risk of death from all causes and cardiovascular disease in sedentary older adults, highlighting the importance of physical activity for longevity.

Exercise offers numerous benefits for the geriatric population, including improved body composition, increased strength, reduced depression and arthritis pain, and lower risks of diabetes and coronary artery disease, yet many healthcare professionals feel unprepared to create effective exercise programs for their patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and older patients: guidelines for the clinician. Christmas, C., Andersen, RA.[2022]

Exercise programs for elderly patients can significantly help in preventing illness and injury, as well as managing existing health conditions like cardiac and metabolic disorders.

The article emphasizes the importance of incorporating strength, endurance, balance, and flexibility into exercise training programs, along with recommendations for effective implementation and patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in the elderly: research and clinical practice. Frankel, JE., Bean, JF., Frontera, WR.[2006]

Supervised exercise interventions for hospitalized older adults (aged ≥75 years) have been shown to be safe and effective in preventing declines in physical function and cognitive abilities.

There is a critical need to integrate tailored physical activity guidelines and physical trainers into healthcare systems to ensure that frail older adults receive appropriate exercise prescriptions, promoting healthier aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity guidelines for older people: knowledge gaps and future directions. Izquierdo, M., Duque, G., Morley, JE.[2022]

A study involving 46 frail elderly patients showed that a 12-week physical training program significantly improved their functional abilities, including balance, walking speed, and muscle strength, compared to a control group (p < 0.01).

The cost of the training program was approximately 1452 DKK per patient, but it is expected to lead to savings in nursing care costs, suggesting that investing in physical training could be beneficial for both health outcomes and healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical training as treatment of reduced functional ability in frail 75+ year-olds living at home. A randomized intervention study in general practice with technological assessment elements]. Vad, E., Worm, C., Lauritsen, JM., et al.[2011]

Regular exercise significantly improves cardiovascular fitness, muscle strength, and bone mass in elderly individuals, helping to counteract the decline in physical capacity and chronic health issues.

Implementing training programs for the elderly is both feasible and beneficial, contributing to a longer and healthier life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Roberge, R.[2021]

Regular participation in physical activity can significantly reduce the physiological decline associated with aging, leading to improvements in health and well-being.

Evidence suggests that exercise not only enhances quality of life but also helps prevent or manage chronic diseases, ultimately contributing to increased life expectancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training as a preventive tool for age-related disorders: a brief review. Ciolac, EG.[2022]

Moderate-intensity exercise can provide multiple benefits for elderly individuals, including improvements in cardiovascular health, reduced fracture risk, enhanced functional ability, and better mental processing.

Exercise is generally safe for older adults, with very few reports of serious complications in studies, suggesting that tailored exercise programs can be effectively implemented without significant risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of exercise for older adults. A review of existing evidence and current recommendations for the general population. Elward, K., Larson, EB.[2004]

Regular exercise, including both aerobic and strength training, significantly improves health, functional capacity, and quality of life for older adults, helping to counteract declines associated with aging.

Older individuals, even those in their 80s and 90s, can effectively adapt to exercise, leading to benefits such as improved cardiovascular function, muscle strength, bone health, and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. [2022]

Regular exercise programs are effective in reducing health-related impairments associated with aging, leading to improved cardiovascular fitness, muscle strength, and overall functional capacity.

Engaging in habitual exercise can help prevent or lessen the risk factors for coronary heart disease in older adults, significantly enhancing their quality of life and ability to maintain independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Habitual exercise for the elderly. Tanaka, H.[2008]

Resistance training has significant health benefits as we age, including improved muscular strength and reduced risk of all-cause mortality, making it comparable to medicine.

Even minimal doses of resistance training (as little as 60 minutes per week, twice a week) can yield substantial physiological and psychological benefits, encouraging more people to participate despite time constraints or perceived difficulty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A minimal dose approach to resistance training for the older adult; the prophylactic for aging. Fisher, JP., Steele, J., Gentil, P., et al.[2022]

Regular exercise is crucial for older adults to prevent muscle loss, frailty, and chronic diseases, with recommendations of at least 150 minutes of moderate aerobic activity per week, along with strength training and balance exercises.

Exercise not only helps maintain physical health but also shows promising benefits for cognitive function and inflammation, suggesting it can enhance memory and reduce inflammation-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise at 65 and beyond. Batt, ME., Tanji, J., Börjesson, M.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6825647/

The effects of same-session combined exercise training on ... This meta-analysis sought to quantify the effects of same-session combined endurance and strength training on fitness in adults aged over 50 years.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12003923/

Heavy Strength Training in Older Adults Older adults are consistently documented to exhibit substantial improvements following heavy‐very heavy strength training, with increases of ~ ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04848038

Study Details | NCT04848038 | Combined Exercise Trial The study will enroll 280 individuals, age 65 to 80 years without cognitive impairment, into a 26-week exercise intervention to test the combined and ...

4. eurapa.biomedcentral.com eurapa.biomedcentral.com/articles/10.1186/s11556-022-00297-x

Effectiveness of power training compared to strength training ... Power training offers more potential for improving muscle power and performance on activity based tests in older adults than strength training.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0197457223002094

Effectiveness of an online multicomponent physical ... The multicomponent physical exercise intervention has the potential to decrease functional dependence among older adults and improve their quality of life.

6. journals.lww.com journals.lww.com/nsca-jscr/fulltext/2019/08000/resistance_training_for_older_adults__position.1.aspx

Resistance Training for Older Adults: Position Statement... 1. A properly designed resistance training program with appropriate instructions for exercise technique and proper spotting is safe for healthy, older adults.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723025927

Hybrid Exercise Program Enhances Physical Fitness and ... The results revealed that all groups had improved to varying degrees in endurance strength, and speed performance after 24 weeks of training.

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1616338

Aerobic or Resistance Exercise, or Both, in Dieting Obese ... Our data suggest that obese older adults can adapt and respond to exercise training during an energy deficit and that combined aerobic and ...

9. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001189

Resistance Exercise Training in Individuals With and ... Adults who participate in RT have ≈15% lower risk of all-cause mortality and 17% lower risk of CVD, compared with adults who report no RT.