No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
144 (estimated)
Sponsor
Pennington Biomedical Research Center · Other
Who this trial is looking for
This trial is looking for African American adults aged 60 and older without regular exercise experience. Participants will take part in an exercise program over the course of 52 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I am African American.
I am 60 years old or older.
I am willing to attend group sessions.
I am able to travel to the study location.
I have not engaged in regular physical activity.
I have a physical performance score of 4 or higher.
I am willing to allow my data to be used for research.
I meet the criteria for Mild Cognitive Impairment.
You may not be able to join if
I have cognitive impairment that affects my participation.
I have been diagnosed with dementia.
I have uncontrolled hypertension.
I have had major heart surgery or stroke in the past 6 months.
I am currently enrolled in another clinical trial.
I have uncontrolled diabetes that affects my participation.
I refuse to participate without sharing amyloid PET scan results.
I have other medical factors that may interfere with my participation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The RAATE-MCI proposal is designed to determine the effects of physical activity on risk factors for Alzheimer's Disease in older African American adults. The study will compare a physical activity program to an active control group. RAATE-MCI is a 52-week randomized controlled trial. 144 African American adults aged 60 and older will be recruited.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. are African American (self-identify)
2. are 60 and older
3. are physically capable of exercise
4. are willing to accept randomization
5. are willing to attend group sessions
6. plan to live in the study area over the next 13 months and capable of traveling to designated study…
Inclusion Criteria:
1. are African American (self-identify)
2. are 60 and older
3. are physically capable of exercise
4. are willing to accept randomization
5. are willing to attend group sessions
6. plan to live in the study area over the next 13 months and capable of traveling to designated study facility for clinic visits and intervention sessions for the next year
7. are free of conditions (e.g. uncontrolled asthma, severe sickle cell disease, etc.) that would make regular exercise unsafe as deemed by the medical investigator
8. have not engaged in regular physical activity
9. have a Short Physical Performance Battery ≥4
10. physically capable of exercise
11. are unable to utilize devices and/or applications as required for study participation
12. willing to attend group sessions
13. willing to allow researchers to use data for research purposes after study participation is completed
14. meet criteria for MCI as defined by the NIA-AA research framework a. cognitive performance below normal range (score \< 1.5 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests)
Exclusion Criteria:
1. have cognitive impairment that would interfere with participating in a group discussion
a. cognitive performance in the demented range (score \< 3 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests)
2. meet criteria for dementia
3. are unwilling to give written informed consent or accept randomization in either study group
4. are too active (as defined by ≥10 min bouts of MVPA as measured by Actigraph) if:
1. Sum of MVPA bouts for the 7 day wear period ≥40 mins
2. Or ≤40 mins of MVPA 10min bouts AND ≥3 days of bouts
5. have uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg).
6. have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis, pulmonary embolus, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
7. are undergoing cardiopulmonary rehabilitation
8. have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
9. have clinically diagnosed osteoporosis that in the judgment of the MI may interfere with study participation
10. are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
11. have another member of the household that is a participant in RAATE or RAATE MCI
12. refuse to participate in the study without disclosure of their amyloid PET scan results
13. refuse to allow anonymized versions of their study data for research after this study is completed.
14. have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol
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