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

280 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for healthy aging?

Research shows that exercise can improve physical function, reduce the risk of diseases like diabetes and heart disease, and enhance overall quality of life in older adults. It is effective in preventing or slowing down functional and cognitive decline, making it a crucial part of healthy aging. ^{1 2 3 4 5}

Is exercise generally safe for older adults?

Exercise is generally safe for older adults, with few serious complications reported in studies. While there is a small risk of cardiovascular and musculoskeletal issues, especially during vigorous activity, these risks are outweighed by the health benefits. It's important to tailor exercise to individual needs and fitness levels to ensure safety. ^{6 7 8 9 10}

How does the treatment of exercise differ from other treatments for healthy aging?

Exercise is unique for healthy aging because it not only improves physical health by enhancing cardiovascular fitness, muscle strength, and bone health, but also supports mental well-being by reducing the risk of cognitive decline and depression. Unlike medications, exercise offers a holistic approach that can prevent or reduce age-related health issues, helping older adults maintain independence and a higher quality of life. ^{11 12 13 14 15}

What is the purpose of this trial?

The number of older Americans will double in the next 4 decades to nearly 90 million, placing an unprecedented financial and resource burden on the health care system. Exercise has clear and demonstrable physical benefits, but a more precise understanding of how exercise supports cognitive function is essential. Demonstrating definitively that exercise as recommended by public health entities has benefits for cognition would have enormous public health implications, encourage the public to adapt more active lifestyles, and stimulate the development of effective exercise delivery programs.

Research Team

Eric D Vidoni, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Exercise and older patients: guidelines for the clinician. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Exercise and aging. [2022]

3. Denmark 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]. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Exercise in the elderly: research and clinical practice. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Physical activity guidelines for older people: knowledge gaps and future directions. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A minimal dose approach to resistance training for the older adult; the prophylactic for aging. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Putting the benefits and risks of aerobic exercise in perspective. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Canada pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Exercise at 65 and beyond. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Healthy Aging. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Habitual exercise for the elderly. [2008]

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[Not Available]. [2021]

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

15. United States pubmed.ncbi.nlm.nih.gov

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