Exercise for Cognitive Impairment

Overseen By Elizabeth Regan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Severe balance impairments, others

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

Compensation: Varies

Number of Visits: 49

Duration: 24 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test a 6-month, twice a week, moderate intensity exercise and coaching program (an in-person group and a distance group) for adults with mild-moderate cognitive impairments living in South Carolina. The main questions it aims to answer are: 1. Is the program practical to conduct, and it is acceptable and enjoyable? The hypothesis is that it will be possible to recruit participants, obtain the desired dosage of moderate intensity fitness and strength training twice a week. 2. Are their changes at 3-months and 6-months in endurance, mobility, cognitive function and perception of cognitive function? The hypotheses are that endurance, strength and mobility will improve and cognitive measures will not decline (remain the same or improve). Participants will exercise twice a week in-person with a coach or at a distance location with coaching support for six months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Brain Health Fitness Program for cognitive impairment?

Research shows that exercise programs, especially those combining different types of exercises like aerobic and balance training, can help improve thinking skills and daily functioning in older adults with mild cognitive impairment or dementia. ^{1 2 3 4 5}

Is exercise generally safe for improving brain health?

Exercise programs, including aerobic and resistance training, have been studied in animals and humans and are generally considered safe. They can improve brain function and reduce harmful proteins in the brain, which suggests they are safe for brain health. ^{6 7 8 9 10}

How is the Brain Health Fitness Program treatment different from other treatments for cognitive impairment?

The Brain Health Fitness Program is unique because it combines physical and cognitive training to improve cognitive status and brain health in individuals with mild cognitive impairment (MCI), unlike many treatments that focus solely on medication. This non-drug approach enhances blood flow in specific brain areas and uses structured exercises with memory aids to help participants remember and perform activities effectively. ^{2 11 12 13 14}

Eligibility Criteria

This trial is for adults with mild to moderate cognitive impairments living in South Carolina. They should be able to participate in a 6-month exercise program, either supervised in-person or monitored remotely. Specific eligibility details are not provided.

Inclusion Criteria

I have been diagnosed with mild to moderate memory problems.

Medically cleared for exercise

I can understand and follow simple instructions.

Exclusion Criteria

I experience significant pain when I move.

I have severe balance issues and need help using exercise equipment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a twice-weekly, moderate intensity exercise and coaching program for six months, either in-person or at a distance.

24 weeks

48 sessions (in-person or virtual)

Mid-program Assessment

Participants are assessed for changes in endurance, mobility, cognitive function, and perception of cognitive function at the 3-month mark.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the completion of the exercise program.

4 weeks

Treatment Details

Interventions

• Brain Health Fitness Program

Trial Overview The study tests a twice-weekly, moderate-intensity exercise and coaching program over six months. It aims to see if the program is practical, enjoyable, and whether it improves endurance, mobility, and cognitive function.

Participant Groups

Group I: Supervised In-Person Group Experimental Treatment 1 Intervention

For the in-person exercise group, exercise activity will be in the twice weekly in-person supervised, directed sessions at the Train Your Brain Fitness Center at the Arnold School of Public Health in Columbia, South Carolina. The exercise intervention will have a goal of up to120 minutes (60 minutes 2 x a week) of moderate intensity exercise, building up to that amount based on ability. This will include 45-60 minutes per week of cardiovascular activity (walking/jogging outside or on a treadmill, stationary bicycling (arm or traditional leg), rowing on an ergometer), 30-60 minutes of strength training (major muscle groups of the trunk, upper and lower extremities) and 15-30 minutes of balance, agility, and mobility exercises. Participants will ramp up to this level depending on their previous activity levels, and initial measures.

Group II: Monitored Distance Group Experimental Treatment 1 Intervention

For the monitored distance group, all activities will be performed at home or in a public gym environment near their home with prescribed plan provided by a fitness coach. The exercise intervention will have a goal of up to 120 minutes (60 minutes 2 x a week) of moderate intensity exercise, building up to that amount based on ability. This will include 45-60 minutes per week of cardiovascular activity (walking/jogging outside or on a treadmill, stationary bicycling (arm or traditional leg), rowing on an ergometer), 30-60 minutes of strength training (major muscle groups of the trunk, upper and lower extremities) and 15-30 minutes of balance, agility, and mobility exercises. Participants will ramp up to this level depending on their previous activity levels, and initial measures.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Foundation of Physical Therapy Research

Collaborator

Trials

1

Recruited

30+

Findings from Research

A 12-month exercise program consisting of walking, strength, balance, and flexibility training significantly slowed the decline in the ability to perform activities of daily living (ADLs) in 134 patients with Alzheimer's disease compared to routine medical care.

The exercise program also improved physical performance, as evidenced by better 6-meter walking speed, with no adverse effects reported, highlighting its safety and potential benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise program for nursing home residents with Alzheimer's disease: a 1-year randomized, controlled trial. Rolland, Y., Pillard, F., Klapouszczak, A., et al.[2022]

A 12-week multimodal physical exercise program significantly improved mobility and executive function in elderly individuals with mild cognitive impairment (MCI), but did not show similar benefits for those with Alzheimer's disease (AD).

The study involved 56 participants (28 in the exercise group and 28 in the control group), and the results suggest that physical exercise can be a beneficial intervention for those in the early stages of neurocognitive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three months of multimodal training contributes to mobility and executive function in elderly individuals with mild cognitive impairment, but not in those with Alzheimer's disease: A randomized controlled trial. de Oliveira Silva, F., Ferreira, JV., Plácido, J., et al.[2019]

A home-based exercise program for patients with Alzheimer's Disease (AD) showed good adherence and a trend towards improved functional performance, particularly in hand function and lower extremity strength, after 6 and 12 weeks.

Despite the positive trends in functional performance, there were also indications of worse depression and lower quality of life ratings among participants, suggesting the need for further research to optimize the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a home-based exercise program in the treatment of Alzheimer's disease: the Maximizing Independence in Dementia (MIND) study. Steinberg, M., Leoutsakos, JM., Podewils, LJ., et al.[2022]

Multicomponent exercise programs, which include aerobic, endurance, balance, and flexibility exercises, significantly improve cognitive function and physical abilities in individuals with dementia, showing a notable effect on global cognition and executive function based on a review of 21 studies.

The exercise interventions also enhance activities of daily living and muscle strength, indicating that multicomponent exercise is a promising management strategy for both dementia and mild cognitive impairment (MCI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Multicomponent Exercise on Cognition, Physical Function and Activities of Daily Life in Older Adults With Dementia or Mild Cognitive Impairment: A Systematic Review and Meta-analysis. Yan, J., Li, X., Guo, X., et al.[2023]

A systematic review of 13 randomized controlled trials involving 811 older adults with Alzheimer's disease found that multimodal exercise significantly improves activities of daily living (ADLs), suggesting it is beneficial for functional capacity in this population.

While multimodal exercise showed positive effects on ADLs, other types of exercise like aerobic and resistance training did not demonstrate significant improvements in mobility, muscle strength, or flexibility, highlighting the importance of tailored exercise programs for older adults with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical exercise at improving functional capacity in older adults living with Alzheimer's disease: a systematic review of randomized controlled trials. Braz de Oliveira, MP., Moreira Padovez, RFC., Serrão, PRMDS., et al.[2023]

A meta-analysis of 19 studies involving 1,145 participants showed that exercise training has a modest positive effect on cognitive function in individuals at risk for or diagnosed with Alzheimer's disease, with an effect size of 0.47.

Aerobic exercise specifically demonstrated a moderate favorable effect on cognitive function (effect size of 0.65), suggesting it may be the most beneficial type of exercise for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Exercise Improve Cognitive Symptoms of Alzheimer's Disease? Panza, GA., Taylor, BA., MacDonald, HV., et al.[2019]

The 12-week Senior Brain Health Exercise (SBHE) program significantly improved basic physical fitness, including lower and upper body strength and aerobic endurance, in elderly women aged 65-79 compared to a control group.

Participants in the exercise group also showed significant improvements in cognitive function and levels of brain-derived neurotrophic factor (BDNF), suggesting that the SBHE program positively impacts both physical and mental health in seniors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of senior brain health exercise program on basic physical fitness, cognitive function and BDNF of elderly women - a feasibility study. Byun, JE., Kang, EB.[2020]

A single session of exercise significantly reduces the levels and activity of BACE1, an enzyme linked to neurodegeneration, in mice fed a high-fat diet, indicating a potential protective effect against neurodegenerative diseases.

Exercise also normalizes the phosphorylation levels of key signaling proteins (Akt and ERK) in the brain, suggesting that physical activity can mitigate cellular stress and inflammation associated with obesity and type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced cortical BACE1 content with one bout of exercise is accompanied by declines in AMPK, Akt, and MAPK signaling in obese, glucose-intolerant mice. MacPherson, RE., Baumeister, P., Peppler, WT., et al.[2018]

A 12-week combined exercise program of aerobic and resistance training significantly reduced beta-amyloid levels in the cerebral cortex of obese rats, suggesting a potential mechanism for improving brain function.

The exercise program also enhanced physical fitness and cognitive function, as indicated by improvements in cardiopulmonary function, muscular endurance, and short-term memory, likely due to increased expression of neurotrophic factors like BDNF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Exercise Program Combining Aerobic and Resistance Training on Protein Expressions of Neurotrophic Factors in Obese Rats Injected with Beta-Amyloid. Lee, G., Kim, Y., Jang, JH., et al.[2023]

In a study of 454 brain autopsies, higher levels of daily physical activity and better motor abilities were found to be independently associated with better cognitive function in older adults, regardless of the presence of Alzheimer's disease or other brain pathologies.

These findings suggest that engaging in regular physical activity may help maintain cognitive function in older adults, potentially providing a cognitive reserve that protects against the effects of brain pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, common brain pathologies, and cognition in community-dwelling older adults. Buchman, AS., Yu, L., Wilson, RS., et al.[2021]

In a study of 113 older adults with Mild Cognitive Impairment (MCI), a 7-month combined physical-cognitive training program significantly improved cognitive status compared to those who did not receive training.

The training also increased cerebral blood flow in the parahippocampal area, suggesting a positive impact on brain health, while no significant effect on gray matter volume loss was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study. [2018]

Physical exercise, particularly resistance exercise, significantly improved upper limb muscle strength in individuals with Mild Cognitive Impairment (MCI), while aerobic exercise enhanced postural balance.

Despite these improvements in body structure and function, physical exercise did not show significant benefits in overall activity outcomes, such as mobility, indicating a need for targeted rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is physical exercise effective at improving body structure & function and activity outcomes in individuals with Mild Cognitive Impairment? a systematic review with quality of evidence assessment. Braz de Oliveira, MP., Moreira Padovez, RFC., Serrão, PRMDS., et al.[2023]

A systematic review of five randomized controlled trials involving 2,878 older adults found no significant evidence that long-term exercise reduces the risk of developing dementia, mild cognitive impairment (MCI), or other cognitive declines.

Despite lower incidence rates of dementia in exercisers (3.7%) compared to controls (6.1%), the overall results did not show a statistically significant protective effect of exercise on cognitive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Preventing Dementia, Mild Cognitive Impairment, and Clinically Meaningful Cognitive Decline: A Systematic Review and Meta-analysis. de Souto Barreto, P., Demougeot, L., Vellas, B., et al.[2019]

The RALLI program, designed for individuals with mild cognitive impairment (MCI), significantly increased exercise participation, with 84% of participants exercising at least once a week after 12 weeks, compared to 62% at baseline.

Participants also reported improved physical health and emotional well-being, with a mean increase of 156 minutes of exercise per week and 76% continuing to exercise after 6 months, indicating the program's effectiveness in addressing cognitive challenges related to exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making physical activity accessible to older adults with memory loss: a feasibility study. Logsdon, RG., McCurry, SM., Pike, KC., et al.[2022]

References

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

Exercise program for nursing home residents with Alzheimer's disease: a 1-year randomized, controlled trial. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Three months of multimodal training contributes to mobility and executive function in elderly individuals with mild cognitive impairment, but not in those with Alzheimer's disease: A randomized controlled trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of a home-based exercise program in the treatment of Alzheimer's disease: the Maximizing Independence in Dementia (MIND) study. [2022]

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

Effect of Multicomponent Exercise on Cognition, Physical Function and Activities of Daily Life in Older Adults With Dementia or Mild Cognitive Impairment: A Systematic Review and Meta-analysis. [2023]

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

Effectiveness of physical exercise at improving functional capacity in older adults living with Alzheimer's disease: a systematic review of randomized controlled trials. [2023]

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

Can Exercise Improve Cognitive Symptoms of Alzheimer's Disease? [2019]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

The effects of senior brain health exercise program on basic physical fitness, cognitive function and BDNF of elderly women - a feasibility study. [2020]

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

Reduced cortical BACE1 content with one bout of exercise is accompanied by declines in AMPK, Akt, and MAPK signaling in obese, glucose-intolerant mice. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of an Exercise Program Combining Aerobic and Resistance Training on Protein Expressions of Neurotrophic Factors in Obese Rats Injected with Beta-Amyloid. [2023]

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

Physical activity, common brain pathologies, and cognition in community-dwelling older adults. [2021]

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

Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Is physical exercise effective at improving body structure & function and activity outcomes in individuals with Mild Cognitive Impairment? a systematic review with quality of evidence assessment. [2023]

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

Exercise Training for Preventing Dementia, Mild Cognitive Impairment, and Clinically Meaningful Cognitive Decline: A Systematic Review and Meta-analysis. [2019]

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

Making physical activity accessible to older adults with memory loss: a feasibility study. [2022]