N/A
N=253
Lifestyle Physical Activity and Cognitive Training Interventions
Cognitive Decline · Cardiovascular Diseases · Cognitive Dysfunction · Cognitive Impairment · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04556305 ↗Enrolled (actual)
253
Serious AEs
1.6%
Results posted
Mar 2025
Primary outcome: Primary: Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks — 0.03; -0.02; 0.01; 0.05 score on a scale — p=.409
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mind (Behavioral); Move (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Rush University Medical Center
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
0.03; -0.02; 0.01; 0.05; 0.00; 0.04 | .409 |
| PRIMARY Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
-0.08; 0.03; 0.04; 0.18; 0.09; 0.06 | .179 |
| PRIMARY Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
-0.14; -0.04; -0.01; -0.12; 0.02; 0.12 | .078 |
| PRIMARY Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
0.29; 0.12; 0.14; 0.17; 0.40; 0.06 | .772 |
| PRIMARY Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
-0.14; -0.04; -0.01; -0.12; 0.02; 0.12 | .078 |
| SECONDARY Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
.01; .05; .05; .05; .05; .05 | .487 |
| SECONDARY Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
.02; .03; -.05; .00; .06; .00 | .371 |
| SECONDARY Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
3.37; 5.26; 6.59; 8.45; 3.25; 4.24 | .798 |
| SECONDARY Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
-.10; .03; .06; .11; -.13; -.13 | .619 |
| SECONDARY Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
-3.52; -2.71; -2.69; -5.10; -3.33; -2.33 | .380 |
| SECONDARY Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
.36; .32; .21; .26; .40; .36 | .995 |
| SECONDARY Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
.03; .15; .08; .02; .01; .21 | .092 |
| SECONDARY Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks |
-10.04; 2.83; 2.13; .09; 6.62; -12.49 | .244 |
Summary
Older women with cardiovascular disease (CVD) are at greater risk for memory loss, an important public health issue due to the negative effects to quality of life and health care costs. This research will be the first to examine the independent and combined effects of a lifestyle physical activity intervention and cognitive training on memory performance and memory-related serum biomarkers in this vulnerable population. The investigators will incorporate a practical lifestyle approach that can be delivered in the home and community settings to prevent or delay memory loss in older women with CVD.
Eligibility Criteria
Inclusion Criteria
- self-identified as women
- ≥ 65 years old
- read/speak English
- patient in the Rush Heart Center for Women
- history of CVD (e.g., coronary artery disease, hypertension) and receiving guideline-directed medical therapy when appropriate
- no regular moderate-vigorous physical activity (≥ 30 minutes ≥ 3 days per week in the past month)
- no cognitive training program in the past month
- no disabilities preventing regular physical activity (Physical Activity Readiness Questionnaire, which includes cardiac and lung disease symptoms)
- written approval from cardiology provider (Physical Activity Readiness Medical Examination); no self-reported significant hearing loss that interferes with normal conversation
- access to a Bluetooth-capable phone or tablet
Exclusion Criteria
- symptoms of unstable cardiac or pulmonary disease in the past month (Physical Activity Readiness Questionnaire)
- blood pressure (systolic ≥ 160 or diastolic ≥ 100 mm Hg)
- cognitive status score < 19 on the blind version (for phone administration) of the Montreal Cognitive Assessment (MoCA) consistent with significant cognitive impairment
- diagnosis of a neurological disease found in the electronic health record (e.g., Alzheimer's disease dementia, Parkinson's disease, vascular dementia)
- transient ischemic attack or small-vessel stroke in the past three months
- taking anti-psychotic medication
- diabetes with an A1C ≥ 9.0 within the past six months
- end-stage renal disease on dialysis (Stage 5)
Data sourced from ClinicalTrials.gov (NCT04556305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.