Aerobic Exercise for Aging-Related Balance Issues

Overseen By Jacqueline Palmer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Insulin-dependent diabetes, Peripheral neuropathy, Myocardial infarction, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

102 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-arm, two-visit, non-randomized, cross sectional study identified as an intervention due to the use of a single bout of aerobic exercise to assess cerebrovascular function under the NIH rules. This study is not masked and its primary purpose is to develop a basic science understanding of the relationship between cerebrovascular health and balance control with aging. This study will involve 102 individuals classified as younger adults, middle-aged adults, and older adults who are neurotypical and cognitively normal. The primary outcome from a clinical trials perspective will be cerebrovascular response to a bout of aerobic exercise (i.e. change in cerebral blood flow with the performance of aerobic exercise on a recumbent stepper exercise machine). Non-interventional outcomes will be EEG measures of cortical activity and biomechanical kinetic and kinematic data recorded during standing balance reactions, as well as biological blood samples for genomic analysis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Aerobic Exercise for Aging-Related Balance Issues?

Research shows that aerobic exercise, like the Exercise for Balance Improvement Program, can significantly improve balance and reduce the fear of falling in older adults. Another study found that aerobic movement led to the greatest improvement in balance compared to other types of endurance training. ^{1 2 3 4 5}

Is aerobic exercise safe for older adults?

Aerobic exercise is generally safe for older adults and can improve balance, strength, and reduce the risk of falls. Studies show that combining aerobic exercise with other types of exercise can enhance physical performance without compromising safety. ^{6 7 8 9 10}

How does aerobic exercise differ from other treatments for aging-related balance issues?

Aerobic exercise, which involves activities like walking and high-movement exercises, uniquely improves balance by engaging the body in movements that challenge stability, leading to significant improvements in balance compared to low-movement exercises like stationary cycling. This treatment is distinct because it not only enhances balance but also improves leg strength and overall physical health, making it a comprehensive approach to addressing balance issues in older adults. ^{2 3 5 11 12}

Research Team

Jacqueline Palmer

Principal Investigator

University of Minnesota

Eligibility Criteria

This study is for neurotypical, cognitively normal adults aged 21-30, 40-55, or 65-95 who can stand and walk unassisted. They must have good vision (20/40 with or without glasses), be able to communicate in English, and consent to participate. People with major orthopedic disabilities cannot join.

Inclusion Criteria

I am either 21-30, 40-55, or 65-95 years old.

My vision is 20/40 or better, with glasses if I need them.

English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of cerebrovascular function and balance control using EEG and biomechanical data

1 week

1 visit (in-person)

Intervention

Participants perform a single bout of aerobic exercise to assess cerebrovascular response

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in cerebrovascular function and balance control post-exercise

1 week

Treatment Details

Interventions

• Aerobic exercise

Trial Overview The trial investigates how a single session of aerobic exercise on a recumbent stepper affects brain blood flow in different age groups. It also looks at brain activity via EEG and balance control through biomechanical assessments.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

Healthy participants in 3 age groups

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

The community-based Exercise for Balance Improvement Program (ExBP) significantly improved dynamic balance and static balance in older adults at risk for falling, with 61 participants undergoing 16 weeks of training.

ExBP also effectively reduced fear of falling among participants, making it a promising alternative exercise regimen for enhancing balance and safety in older nonfallers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Community-Based Exercise Program on Balance Performance and Fear of Falling in Older Nonfallers at Risk for Falling: A Randomized, Controlled Study. Zhao, Y., Chung, PK., Tong, TK.[2017]

A meta-analysis of eight randomized clinical trials involving 335 healthy older adults found that various exercise interventions improved static balance, but these improvements were not statistically significant compared to control groups.

Despite the lack of significant differences, the study suggests that exercise, including resistance, aerobic, and balance training, may still play a beneficial role in maintaining balance in older adults as they age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Different Training Modalities on Static Balance in Older Adults: A Systematic Review and Meta-Analysis. Labata-Lezaun, N., Rodríguez-Rodríguez, S., López-de-Celis, C., et al.[2023]

In a study of 106 sedentary older adults, short-term endurance training showed a dose-response effect on balance improvement, with aerobic movement leading to an 18% improvement on a balance beam, compared to 3% for cycling and 7% for walking.

Walking exercise was the only type that significantly improved multiple outcomes, including gait speed (5% increase) and overall health status, indicating it may be the most beneficial form of exercise for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effects of three types of endurance training on balance and other fall risk factors in older adults. Buchner, DM., Cress, ME., de Lateur, BJ., et al.[2019]

The study identified specific verbal and nonverbal markers that can differentiate between high, medium, and low intensity balance exercises in older adults, which is crucial for developing effective rehabilitation programs.

Key findings included that participants showed increased delays in starting tasks and more physical reactions (like bracing and swaying) as the intensity of the balance challenge increased, indicating that these markers can help assess and prescribe appropriate balance exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Markers of the Intensity of Balance Challenge: Observational Study of Older Adult Responses to Balance Tasks. Farlie, MK., Molloy, E., Keating, JL., et al.[2016]

Step aerobics (SA) significantly improved balance in older adults, as evidenced by notable enhancements in the Timed Up and Go (TUG) and Performance-Oriented Assessment of Mobility (POMA) tests after an 8-week intervention with 28 participants.

Both step aerobics and stability ball (SB) exercises led to improvements in general health perception among participants, suggesting these activities can enhance quality of life for seniors compared to a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of step aerobics and the stability ball to improve balance and quality of life in community-dwelling older adults - a randomized exploratory study. Dunsky, A., Yahalom, T., Arnon, M., et al.[2018]

The study involved 21 normal adults who participated in a 2-week exercise program, with significant improvements in balance measured by the overall stability index (OSI) and anterioposterior stability index (APSI) in the aero-step exercise group (AEG).

The flat floor exercise group (FEG) also showed improvements in the mediolateral stability index (MLSI), indicating that both exercise programs can enhance balance abilities, but the aero-step program was particularly effective for OSI and APSI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Exercise Program Using Aero-step Equipment on the Balance Ability of Normal Adults. Lee, S., Park, J., Lee, D.[2021]

Combined aerobic exercise with resistance/strength training and other activities significantly improves physical performance in the elderly, enhancing strength, balance, mobility, and reducing fall risk.

Compared to single aerobic exercise, combined exercise (CEX) showed superior benefits in various physical fitness measures, including gait speed and lower limb strength, highlighting the importance of multi-component training for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Exercise Combination Intervention to Improve Physical Performance Among the Elderly: A Systematic Review. Bai, X., Soh, KG., Omar Dev, RD., et al.[2022]

About 40.7% of older adults in the U.S. engage in balance activities at least once a week, but only 12.0% meet the recommended guidelines for both balance and aerobic/muscle-strengthening activities for at least three days a week.

Participation in balance activities varies significantly based on factors like sex, education, income, and body mass index, indicating that there are opportunities to enhance engagement in these important physical activities among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Older Adults' Participation in Balance Activities. Hyde, ET., Omura, JD., Chen, TJ., et al.[2022]

A year-long aerobic exercise program significantly improved aerobic fitness in elderly participants, as shown by an increase in peak oxygen uptake (V˙O2peak) from 22.8 to 27.9 mL·min·kg.

The training also enhanced orthostatic tolerance (OT) by improving carotid baroreceptor reflex (CBR) function, which helps maintain blood flow to the brain during changes in posture, indicating that exercise can be safe and beneficial for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Exercise Training Improves Orthostatic Tolerance in Aging Humans. Xu, D., Wang, H., Chen, S., et al.[2018]

Aqua aerobic therapy significantly improved gait patterns and recovery time in older adults, as evidenced by reduced stride time and enhanced leg strength after a perturbation test.

The study, involving 15 participants, demonstrated that this exercise method effectively reduces body weight and fat mass, contributing to a lower risk of falls among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aqua Aerobic Therapy Exercise for Older Adults on Muscular Strength, Agility and Balance to Prevent Falling during Gait. Kim, SB., O'sullivan, DM.[2021]

A systematic review of 95 trials found that balance exercise interventions significantly improve balance performance in older adults compared to non-balance exercises, with effect sizes ranging from 0.31 to 0.50.

Despite the positive effects, there was considerable variability in the results, indicating that factors like exercise frequency and duration only explained a small portion of the differences in outcomes, suggesting that more standardized approaches may be needed for better understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programme frequency, type, time and duration do not explain the effects of balance exercise in older adults: a systematic review with a meta-regression analysis. Farlie, MK., Robins, L., Haas, R., et al.[2022]

In a study of 49 sedentary women aged 60 to 76, moderate-intensity walking did not show significant changes in traditional balance measures, suggesting that these methods may not fully capture the effects of exercise on balance.

However, advanced dynamical measures revealed a loss of complexity in postural control after walking tests, indicating potential early signs of balance deterioration in older adults, which could be important for future exercise recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of repeated effort induced by a 6-min walk test on postural response in older sedentary women. Bernard, PL., Blain, H., Tallon, G., et al.[2018]

References

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

Effectiveness of a Community-Based Exercise Program on Balance Performance and Fear of Falling in Older Nonfallers at Risk for Falling: A Randomized, Controlled Study. [2017]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Different Training Modalities on Static Balance in Older Adults: A Systematic Review and Meta-Analysis. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

A comparison of the effects of three types of endurance training on balance and other fall risk factors in older adults. [2019]

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

Clinical Markers of the Intensity of Balance Challenge: Observational Study of Older Adult Responses to Balance Tasks. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The use of step aerobics and the stability ball to improve balance and quality of life in community-dwelling older adults - a randomized exploratory study. [2018]

6. Japan pubmed.ncbi.nlm.nih.gov

Effects of an Exercise Program Using Aero-step Equipment on the Balance Ability of Normal Adults. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Aerobic Exercise Combination Intervention to Improve Physical Performance Among the Elderly: A Systematic Review. [2022]

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

U.S. Older Adults' Participation in Balance Activities. [2022]

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

Aerobic Exercise Training Improves Orthostatic Tolerance in Aging Humans. [2018]

10. Japan pubmed.ncbi.nlm.nih.gov

Effects of Aqua Aerobic Therapy Exercise for Older Adults on Muscular Strength, Agility and Balance to Prevent Falling during Gait. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Programme frequency, type, time and duration do not explain the effects of balance exercise in older adults: a systematic review with a meta-regression analysis. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Influence of repeated effort induced by a 6-min walk test on postural response in older sedentary women. [2018]