Exercise Program for Cognitive Decline
(MOVE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Boulder
Must not be taking: Antipsychotics
Disqualifiers: Physically active, Psychiatric disorders, others
No Placebo Group
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.
12345Is 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.
16789How 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.
15101112Eligibility 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.
+2 more
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
+4 more
Trial 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)
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: Vigorous Intensity Exercise, Challenging Goal DifficultyExperimental Treatment1 Intervention
Participants are assigned to exercise at a vigorous intensity and create challenging goals.
Group II: Vigorous Intensity Exercise, Basic Goal DifficultyExperimental Treatment1 Intervention
Participants are assigned to exercise at a vigorous intensity and create basic goals.
Group III: Moderate Intensity Exercise, Challenging Goal DifficultyExperimental Treatment1 Intervention
Participants are assigned to exercise at a moderate intensity and create challenging goals.
Group IV: Moderate Intensity Exercise, Basic Goal DifficultyExperimental Treatment1 Intervention
Participants are assigned to exercise at a moderate intensity and create basic goals.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hiawatha Davis Jr. Recreation CenterDenver, CO
Aurora Center for Active AdultsAurora, CO
University of Colorado at BoulderBoulder, CO
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Who Is Running the Clinical Trial?
University of Colorado, BoulderLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Adherence to exercise programs and determinants of maintenance in older adults with mild cognitive impairment. [2022]After a randomized controlled trial showing that improvement on some aspects of cognitive function was related to adherence to an exercise program, determinants of adherence and maintenance were further studied. Older adults with mild cognitive impairment were contacted 6 mo after the end of exercise programs for a telephone interview addressing patterns of adherence and determinants of maintenance. Mean adherence during the trial was 53%. About one third of participants had lapses during the trial but completed, one third had no lapses, and one third dropped out or never started. Practical barriers (time, location) were related to not starting and functional limitations to dropout. After the trial 25% of participants continued the programs, 14% reported intention to continue, and 61% quit. Maintenance was determined by fewer health complaints, higher satisfaction with the programs, and better adherence during the programs. Although maintenance was low, this study identified several reasons and barriers to adherence and maintenance that could be addressed.
Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. [2023]To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care.
Exercise program for nursing home residents with Alzheimer's disease: a 1-year randomized, controlled trial. [2022]To investigate the effectiveness of an exercise program in improving ability to perform activities of daily living (ADLs), physical performance, and nutritional status and decreasing behavioral disturbance and depression in patients with Alzheimer's disease (AD).
Chemotherapy-related symptoms and exercise adherence in older patients with myeloid neoplasms. [2023]Exercise may ameliorate treatment-related symptoms, but older adults have lower exercise adherence compared to their younger counterparts due to treatment-related symptoms.
Adherence support strategies for exercise interventions in people with mild cognitive impairment and dementia: A systematic review. [2021]Exercise-based therapy may improve health status for people with Mild Cognitive Impairment (MCI) or dementia but cannot work without adherence, which has proven difficult. This review aimed to evaluate strategies to support adherence among people with MCI or Dementia and was completed in Nottingham/UK in 2017. A narrative synthesis was used to investigate the effectiveness or usefulness of adherence support strategies. Fifteen adherence support strategies were used including theoretical underpinning (programmes based on behavior change theories), individual tailoring, worksheets and exercise booklets, goal setting, phone calls or reminders, newsletters, support to overcome exercise barriers, information, adaptation periods, individual supervision, support for clinicians, group setting, music, accelerometers/pedometers and emphasis on enjoyable activities. Music was the only strategy that was investigated in a comparative design but was found to be effective only for those who were generally interested in participating in activities. A wide range of adherence support strategies are being included in exercise interventions for people with MCI or dementia, but the evidence regarding their effectiveness is limited.
Exercise level and cognitive decline: the MoVIES project. [2022]Growing evidence suggests that physical exercise may be protective against cognitive impairment and decline. A prospective study of a representative rural community sample (N = 1,146) aged 65+ years examined self-reported exercise habits and measured global cognitive function using the Mini-Mental State Examination (MMSE). A composite variable "exercise level" combining type, frequency, and duration of exercise was created with three levels: "high exercise" (aerobic exercise of > or = 30 minute duration > or = 3 times a week), "low exercise" (all other exercise groups), and "no exercise." Cognitive decline was defined as being in the 90 percentile of decline in this cohort, ie, declining by 3 or more MMSE points during the 2-year interval between two assessments. In a multiple regression model, high exercise level at the baseline assessment was negatively associated with, ie, was protective against, being in the group with the greatest amount of decline at the follow-up assessment, after adjusting for likely confounders (odds ratio = 0.39; 95% confidence interval, 0.19, 0.78). When high exercise was redefined using frequency as > or = 5 days per week as the threshold, as per the Surgeon General's guidelines, both low exercise and high exercise were negatively associated with cognitive decline. Exercise may have implications for prevention of cognitive decline.
Physical inactivity in older adults with cognitive impairment without dementia: room for improvement. [2023]Persons with cognitive impairment without dementia are at high risk of adverse health outcomes. Tailored intervention targeting moderate-vigorous physical activity (MVPA) may reduce these risks.
Adherence to exercise interventions in older people with mild cognitive impairment and dementia: A systematic review and meta-analysis. [2021]Adherence to physical exercise is associated with multiple benefits in people with mild cognitive impairment (MCI) and dementia. Given the gap in research, this systematic literature review aimed to determine in the context of exercise intervention studies for people with MCI and dementia: 1. How adherence is defined, monitored and recorded; 2. Adherence rates; 3. Attrition, compliance and adverse events and 4. Intervention characteristics associated with adherence. Embase, Medline, PsychInfo, SPORTDiscus, AMED, CINAHL and the International Bibliography of Social Sciences were searched in November 2018. The data were analyzed through descriptive and correlation/inferential statistics. Forty-one studies were included, 34 involving participants with dementia (n = 2149) and seven participants with MCI (n = 970). Half of the studies operationally defined adherence. Mean adherence rate was 70% [CI, 69-73%]. Adherence was significantly associated with endurance/resistance training, and interventions not including walking. The review found a lack of consistency around reporting of adherence and of key variables mediating adherence, including compliance, attrition and adverse events. Further research using more reliable measures is needed to confirm whether a correlation exists between length of interventions and adherence in participants with MCI and dementia and to identify the factors or strategies that mediate adherence in this population. Relevant implications for practice include a consideration in the development of new interventions of elements associated with higher adherence in this review, such as endurance/resistance training, and the provision of exercise in group formats.
Exercise prescription for the elderly: current recommendations. [2018]The benefits for elderly individuals of regular participation in both cardiovascular and resistance-training programmes are great. Health benefits include a significant reduction in risk of coronary heart disease, diabetes mellitus and insulin resistance, hypertension and obesity as well as improvements in bone density, muscle mass, arterial compliance and energy metabolism. Additionally, increases in cardiovascular fitness (maximal oxygen consumption and endurance), muscle strength and overall functional capacity are forthcoming allowing elderly individuals to maintain their independence, increase levels of spontaneous physical activity and freely participate in activities associated with daily living. Taken together, these benefits associated with involvement in regular exercise can significantly improve the quality of life in elderly populations. It is noteworthy that the quality and quantity of exercise necessary to elicit important health benefits will differ from that needed to produce significant gains in fitness. This review describes the current recommendations for exercise prescriptions for the elderly for both cardiovascular and strength/resistance-training programmes. However, it must be noted that the benefits described are of little value if elderly individuals do not become involved in regular exercise regimens. Consequently, the major challenges facing healthcare professionals today concern: (i) the implementation of educational programmes designed to inform elderly individuals of the health and functional benefits associated with regular physical activity as well as how safe and effective such programmes can be; and (ii) design interventions that will both increase involvement in regular exercise as well as improve adherence and compliance to such programmes.
Making physical activity accessible to older adults with memory loss: a feasibility study. [2022]For individuals with mild cognitive impairment (MCI), memory loss may prevent successful engagement in exercise, a key factor in preventing additional disability. The Resources and Activities for Life Long Independence (RALLI) program uses behavioral principles to make exercise more accessible for these individuals. Exercises are broken into small steps, sequenced, and linked with cues to help participants remember them. Memory aids, easy-to-follow instructions, and tracking forms to facilitate adherence and proper technique are provided to enhance exercise training and compensate for memory loss.
Biomarkers for evaluating the effects of exercise interventions in patients with MCI or dementia: A systematic review and meta-analysis. [2021]To summarize the biomarkers for evaluating the effects of exercise interventions in patients with cognitive impairment associated with aging, as well as their responses to exercise interventions.
Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. [2021]Aim: We developed a home-based goal-directed exercise program with telephonic coaching to overcome barriers to exercise participation in cognitively impaired older adults. Methods: Six patients with Motoric Cognitive Risk syndrome at high risk for dementia were enrolled, three assigned to goal-directed exercises and three to stretching exercises. All participants underwent an in-person training session followed by a session at home with a telephonic coach. Sessions were supervised by a physiatrist, and exercise programs were personalized. Results: In-person training and remote telephonic coaching support promoted adherence. There were no adverse effects and interventions were rated highly. Participant and logistical barriers were identified that can inform design of home-based clinical trials. Conclusion: Home-based exercises are safe and feasible in older adults with Motoric Cognitive Risk.