Exercise Program for Cognitive Decline

(MOVE Trial)

Recruiting at 2 trial locations

Overseen By Angela Bryan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Boulder

Must not be taking: Antipsychotics

Disqualifiers: Physically active, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 17

22 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to conduct a small-scale test of a goals-based program to help people to exercise more and learn what people like or don't like about the procedures. This program is being designed for individuals aged 45-65 from the Black community. Low levels of physical activity are related to health problems such as heart disease, diabetes, and cognitive decline. People of color are more negatively impacted by these conditions and have also historically been underrepresented by research seeking to increase physical activity. The investigators have developed this goals-based exercise promotion program with the help of a Black-led community-based organization (The Gyedi Project) and a Community Advisory Board made up of stakeholders in the Black community, and now the investigators are conducting a trial of its feasibility and acceptability.

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 are on antipsychotic medications or being treated for serious psychiatric disorders like Alzheimer's or dementia.

What data supports the effectiveness of the treatment Exercise Adherence Program for cognitive decline?

Research shows that sticking to an exercise program can improve some aspects of cognitive function in older adults with mild cognitive impairment. However, maintaining regular exercise is challenging, and strategies like goal setting, reminders, and enjoyable activities can help improve adherence. ^{1 2 3 4 5}

Is the Exercise Program for Cognitive Decline safe for humans?

Exercise programs, including those for cognitive decline, are generally safe for humans. Studies show that regular exercise can reduce risks of heart disease, diabetes, and improve overall health in older adults, with no significant adverse events reported in the context of cognitive impairment. ^{1 6 7 8 9}

How does the Exercise Adherence Program treatment differ from other treatments for cognitive decline?

The Exercise Adherence Program is unique because it uses behavioral strategies to help people with memory loss stick to an exercise routine, breaking exercises into small, easy-to-remember steps and using memory aids to support adherence. This approach is different from other treatments that may not focus on overcoming memory-related barriers to exercise. ^{1 5 10 11 12}

Eligibility Criteria

This trial is for Black individuals aged 45-65 who may be experiencing mild cognitive impairment or dementia. It aims to test a goals-based exercise program developed with the help of the Black community to improve physical activity and potentially reduce cognitive decline.

Inclusion Criteria

Planning to remain in the Denver metro area for the next two months

Identify as Black or African American

I am between 45 and 65 years old.

Exclusion Criteria

Currently physically active (i.e., >90 min/week of moderate PA or >40 min/week of vigorous PA consistently for the past 6 months)

Answers 'yes' to 1 or more of the 7 questions of the PAR-Q+

Blood pressure at baseline or before exercise is greater than 140/90

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including demographics, mental status, identity, and physical activity levels

1 week

1 visit (in-person)

Intervention

Participants engage in a goals-based exercise program with varying intensities and goal difficulties

8 weeks

14 visits (in-person)

Follow-up

Participants are monitored for exercise adherence, benefits, and barriers post-intervention

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Exercise Adherence Program

Trial Overview The study tests a new exercise promotion program that uses goal setting and tailored exercise intensity. Participants will provide feedback on what they like or dislike about the program, helping researchers assess its feasibility and acceptability within the target demographic.

Participant Groups

Group I: Vigorous Intensity Exercise, Challenging Goal Difficulty Experimental Treatment 1 Intervention

Participants are assigned to exercise at a vigorous intensity and create challenging goals.

Group II: Vigorous Intensity Exercise, Basic Goal Difficulty Experimental Treatment 1 Intervention

Participants are assigned to exercise at a vigorous intensity and create basic goals.

Group III: Moderate Intensity Exercise, Challenging Goal Difficulty Experimental Treatment 1 Intervention

Participants are assigned to exercise at a moderate intensity and create challenging goals.

Group IV: Moderate Intensity Exercise, Basic Goal Difficulty Experimental Treatment 1 Intervention

Participants are assigned to exercise at a moderate intensity and create basic goals.

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

In a study of older adults with mild cognitive impairment, adherence to an exercise program was only 53%, with one-third of participants dropping out or not starting due to practical barriers like time and location.

After the exercise program ended, only 25% of participants continued exercising, but those who reported fewer health complaints and higher satisfaction with the program were more likely to maintain their exercise habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to exercise programs and determinants of maintenance in older adults with mild cognitive impairment. Tak, EC., van Uffelen, JG., Paw, MJ., et al.[2022]

The PrAISED intervention, which involved up to 50 therapy sessions focusing on exercise and functional activities for adults with early dementia or mild cognitive impairment, did not show significant improvements in daily living activities, physical activity, or quality of life compared to usual care after 12 months.

Although the intervention group experienced fewer falls (79 falls) compared to the control group (200 falls), the difference was not statistically significant, indicating that the exercise program did not effectively reduce fall risk or improve overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. Harwood, RH., Goldberg, SE., Brand, A., et al.[2023]

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]

In a pilot study involving 7 older patients (average age 74.3 years) with myeloid neoplasms undergoing chemotherapy, exercise adherence was found to be negatively impacted by treatment-related symptoms such as pain, sadness, and anxiety.

The study suggests that monitoring and managing these symptoms can enhance exercise adherence, which may lead to improved overall well-being for older adults undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy-related symptoms and exercise adherence in older patients with myeloid neoplasms. Wang, K., Consagra, W., Jensen-Battaglia, M., et al.[2023]

Exercise-based therapy can potentially improve health for individuals with Mild Cognitive Impairment (MCI) or dementia, but adherence to these exercise programs is a significant challenge.

Fifteen different strategies were evaluated to support adherence, with music being the only strategy shown to be effective in a comparative design, but only for those already interested in activities, highlighting the need for more robust evidence on adherence strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence support strategies for exercise interventions in people with mild cognitive impairment and dementia: A systematic review. van der Wardt, V., Hancox, J., Gondek, D., et al.[2021]

In a study of 1,146 older adults (aged 65+) over two years, those who engaged in high levels of exercise (aerobic exercise for at least 30 minutes, three or more times a week) were significantly less likely to experience cognitive decline, with an odds ratio of 0.39, indicating a protective effect.

Even when high exercise was defined as five or more days a week, both low and high exercise levels were associated with reduced risk of cognitive decline, suggesting that any level of regular physical activity may help in preventing cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise level and cognitive decline: the MoVIES project. Lytle, ME., Vander Bilt, J., Pandav, RS., et al.[2022]

56% of older adults with cognitive impairment without dementia (CIND) were found to be physically inactive, with self-rated health, difficulty walking, total assets, and education level being significant predictors of inactivity.

Despite the high prevalence of inactivity, 61% of inactive participants were capable of engaging in greater moderate-vigorous physical activity (MVPA), suggesting that tailored interventions could enhance their health and cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical inactivity in older adults with cognitive impairment without dementia: room for improvement. Miller, MJ., Cenzer, I., Barnes, DE., et al.[2023]

A systematic review of 41 studies involving 3119 participants with mild cognitive impairment (MCI) and dementia found that the average adherence rate to exercise interventions was 70%, indicating a generally positive response to physical activity in this population.

Adherence to exercise was notably higher in interventions focused on endurance and resistance training rather than walking, suggesting that these types of exercises may be more effective in promoting consistent participation among individuals with MCI and dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to exercise interventions in older people with mild cognitive impairment and dementia: A systematic review and meta-analysis. Di Lorito, C., Bosco, A., Booth, V., et al.[2021]

Regular participation in cardiovascular and resistance-training programs significantly reduces the risk of chronic diseases like coronary heart disease and diabetes in elderly individuals, while also improving bone density, muscle mass, and overall functional capacity.

To maximize health benefits, tailored exercise prescriptions are necessary, but the challenge remains in effectively educating and encouraging elderly individuals to engage in and adhere to regular exercise regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise prescription for the elderly: current recommendations. Mazzeo, RS., Tanaka, H.[2018]

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]

A systematic review of 26 trials involving exercise interventions for patients with cognitive impairment found that regular exercise significantly reduces inflammation markers like IL-6 and TNF-α, suggesting a beneficial effect on brain health.

Exercise also positively impacts lipid metabolism by lowering low-density lipoprotein levels, but more research is needed to explore its effects on other important cognitive biomarkers like Aβ and tau.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers for evaluating the effects of exercise interventions in patients with MCI or dementia: A systematic review and meta-analysis. Huang, X., Zhao, X., Li, B., et al.[2021]

A home-based exercise program with telephonic coaching was developed for older adults with Motoric Cognitive Risk syndrome, showing that this approach is safe and feasible for promoting exercise participation.

The program had no adverse effects, and participants rated it highly, indicating that personalized and supervised exercise can effectively overcome barriers to physical activity in cognitively impaired individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. Ambrose, AF., Gulley, E., Verghese, T., et al.[2021]

References

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

Adherence to exercise programs and determinants of maintenance in older adults with mild cognitive impairment. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. [2023]

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

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

4. Germany pubmed.ncbi.nlm.nih.gov

Chemotherapy-related symptoms and exercise adherence in older patients with myeloid neoplasms. [2023]

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

Adherence support strategies for exercise interventions in people with mild cognitive impairment and dementia: A systematic review. [2021]

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

Exercise level and cognitive decline: the MoVIES project. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Physical inactivity in older adults with cognitive impairment without dementia: room for improvement. [2023]

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

Adherence to exercise interventions in older people with mild cognitive impairment and dementia: A systematic review and meta-analysis. [2021]

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

Exercise prescription for the elderly: current recommendations. [2018]

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

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

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

Biomarkers for evaluating the effects of exercise interventions in patients with MCI or dementia: A systematic review and meta-analysis. [2021]

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

Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. [2021]