Exercise Training for Aging

(STRRIDE IV Trial)

Overseen By Leanna M Ross, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Cardiometabolic medications

Must not be taking: Nicotine products

Disqualifiers: Tobacco use, Insulin-dependent diabetes, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

8 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. However, you must be on a stable dose of any cardiometabolic medications for at least one month to participate.

What data supports the effectiveness of the treatment High/Mod, High/Vig, Low/Mod in the clinical trial Exercise Training for Aging?

Research shows that regular exercise can slow down age-related declines in muscle and heart health, improve mobility, mental health, and quality of life, and help prevent or manage chronic diseases like heart disease and diabetes. Exercise is especially beneficial for older adults, including those who are frail, by enhancing physical function and independence. ^{1 2 3 4 5}

Is exercise training safe for older adults?

Exercise training, including resistance training and high-intensity interval training, is generally safe for older adults. Studies show that these exercises are well-tolerated and can improve health outcomes, with serious adverse events being uncommon. ^{6 7 8 9 10}

How does the Exercise Training for Aging treatment differ from other treatments for aging-related conditions?

The Exercise Training for Aging treatment is unique because it combines different intensities of exercise, such as High/Mod, High/Vig, and Low/Mod, to specifically target age-related declines in muscle strength, endurance, and overall physical function. This approach is novel as it integrates both aerobic and resistance training, which are shown to improve muscle mass, strength, and reduce frailty in older adults, unlike standard treatments that may not address these multiple aspects of aging. ^{7 11 12 13 14}

What is the purpose of this trial?

The primary purpose of this study is to assess the effects of aging on markers of physical reserve and exercise-induced adaptations in resilience in older adults who completed a structured exercise program within the last 15 years (Parent trial: STRRIDE-PD; NCT00962962). This feasibility pilot study will enroll up to 8 participants to complete a 6-month aerobic exercise intervention.

Research Team

Leanna M Ross, PhD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults who previously completed the STRRIDE-PD exercise program. Participants should have a BMI between 18 and 45 kg/m2 and be on a stable dose of any cardiometabolic medications for at least one month.

Inclusion Criteria

I participated in the STRRIDE-PD trial.

My BMI is between 18 and 45.

I have been on a stable dose of heart or diabetes medication for at least a month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 6-month aerobic exercise intervention with varying intensities

24 weeks

Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)

Follow-up

Participants are monitored for changes in body composition, perceived global health, metabolic syndrome z-score, insulin sensitivity, and cardiorespiratory fitness

4 weeks

Treatment Details

Interventions

• High/Mod
• High/Vig
• Low/Mod

Trial Overview The study tests how well older adults respond to different intensities of aerobic exercise (Low/Mod, High/Mod, High/Vig) over six months, focusing on physical resilience and adaptations due to aging.

Participant Groups

Group I: Low Amount/Moderate Intensity (Low/Mod) Experimental Treatment 1 Intervention

Six months of low amount/moderate intensity aerobic exercise

Group II: High Amount/Vigorous Intensity (High/Vig) Experimental Treatment 1 Intervention

Six months of high amount/vigorous intensity aerobic exercise

Group III: High Amount/Moderate Intensity (High/Mod) Experimental Treatment 1 Intervention

Six months of high amount/moderate intensity aerobic exercise

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

A study involving 146 older adults with frailty or pre-frailty showed that both supervised and home-based exercise programs significantly improved walking speed and muscle strength after 3 months.

Participants in the supervised exercise group experienced greater improvements in physical performance tests compared to those in the home-based group, highlighting the benefits of professional supervision in exercise programs for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of concurrent aerobic and resistance exercise in frail and pre-frail older adults: A randomized trial of supervised versus home-based programs. Meng, NH., Li, CI., Liu, CS., et al.[2022]

Exercise interventions have a positive effect on physical determinants and functional abilities in frail older adults, based on a systematic review of 47 randomized controlled trials.

Multicomponent training programs lasting at least 5 months, with sessions three times a week for 30-45 minutes, showed the best outcomes for managing frailty compared to other exercise types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise interventions for the management of frailty: a systematic review. Theou, O., Stathokostas, L., Roland, KP., et al.[2022]

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]

Resistance training (RT) is the only non-drug method proven to effectively counteract age-related declines in muscle mass, strength, and power, while also reducing risks of various health issues like cardiovascular disease and depression.

Minimal-dose RT strategies, which involve lower training volumes and can be performed with minimal equipment, are effective in improving strength and functional ability, making it easier for more people to participate and potentially enhancing overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. Fyfe, JJ., Hamilton, DL., Daly, RM.[2022]

In a review of 121 trials involving 6700 older adults, most adverse events related to progressive resistance strength training were musculoskeletal issues like muscle strains and joint pain, particularly in participants with pre-existing health conditions or those engaging in high-intensity training.

Adverse events were often underreported, highlighting the need for clearer definitions and consistent reporting in future studies to better inform practitioners about the risks and benefits of strength training in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported in progressive resistance strength training trials in older adults: 2 sides of a coin. Liu, CJ., Latham, N.[2010]

A scoping review of 69 studies on high-intensity interval training (HIIT) in older adults found that HIIT protocols are generally well-tolerated and can provide significant health benefits, particularly in improving cardiorespiratory fitness.

Most research has focused on healthy older adults, highlighting a need for larger studies and more investigation into HIIT's effects on older adults with various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. Marriott, CFS., Petrella, AFM., Marriott, ECS., et al.[2021]

Resistance training significantly enhances muscular strength and endurance in older adults, contributing to improved functional independence and quality of life, even in the oldest individuals.

The combination of strength training and aerobic exercise in circuit training not only increases muscle strength but also improves balance, coordination, and cardiovascular health, reducing disability risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of strength and resistance training on cardiovascular disease risk factors and outcomes in older adults. Williams, MA., Stewart, KJ.[2013]

References

1. France pubmed.ncbi.nlm.nih.gov

International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. [2021]

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

Effects of aerobic exercise training in community-based subjects aged 80 and older: a pilot study. [2019]

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

Exercise in Octogenarians: How Much Is Too Little? [2022]

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

Effects of concurrent aerobic and resistance exercise in frail and pre-frail older adults: A randomized trial of supervised versus home-based programs. [2022]

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

The effectiveness of exercise interventions for the management of frailty: a systematic review. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

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

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

Musculoskeletal exercise: Its role in promoting health and longevity. [2023]

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

Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. [2022]

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

Adverse events reported in progressive resistance strength training trials in older adults: 2 sides of a coin. [2010]

10. Switzerland pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. [2021]

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

The role of progressive resistance training and nutrition in the preservation of lean body mass in the elderly. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Exercise as Therapy for Frailty. [2022]

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

Impact of strength and resistance training on cardiovascular disease risk factors and outcomes in older adults. [2013]

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

A pilot study of partial unweighted treadmill training in mobility-impaired older adults. [2021]