Clinical trial NCT04556305: Lifestyle Physical Activity and Cognitive Training Interventions
Official title: Lifestyle Physical Activity and Cognitive Training Interventions: Preventing Memory Loss in Older Women With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Decline
Cardiovascular Diseases
Cognitive Dysfunction
Cognitive Impairment
Mild Cognitive Impairment
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 253
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Women experience disproportionately high rates of cognitive dysfunction, especially with increasing age, compared to men. Some research suggests that older women have a higher incidence of cognitive dysfunction with greater severity and more rapid decline.Furthermore, cardiovascular disease (CVD) increases the risk for cognitive dysfunction by 29-66% and affects 44 million women in the US.

One particularly distressing type of cognitive dysfunction due to CVD is loss of memory. Memory loss leads to reduced independence, lower quality of life, and higher healthcare costs. To prevent or delay loss of memory among older women with CVD, there is an urgent need to develop lifestyle interventions that can be scaled.

The long-term goal is to create and implement multi-modal lifestyle interventions (interventions that have multiple behavioral components) that will prevent or delay memory loss in older adults. The investigators initially focus on women with CVD due to their high risk. Physical activity interventions and cognitive training each prevent memory loss in healthy older adults.

Thus, the investigators will evaluate the efficacy of MindMoves, a 24-week multi-modal intervention, on memory performance and memory-related serum biomarkers. The investigators will examine the serum biomarkers of brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VEGF), and (c) insulin-like growth factor 1 (IGF-1). Data collection will occur at baseline, 24 weeks, 48 weeks, and 72 weeks. MindMoves is a combination of two evidence-based interventions. Mind is the cognitive training program BrainHQ modified to a lifestyle-focused electronic tablet format. Mind improves memory performance in healthy older adults and those with heart failure. Move is a modified lifestyle physical activity intervention from the Women's Lifestyle Physical Activity Program, which the investigators piloted in women with CVD. The investigators recently tested the feasibility of MindMoves.

Using a 2x2 factorial design, the investigators will recruit 254 older women with CVD from cardiology clinics and randomize them to one of the following conditions: (1) Mind, (2) Move, (3) MindMoves, or (4) usual care control. This approach will allow us to evaluate main and interaction effects of Mind and/or Move on memory performance and memory-related biomarkers at 24, 48, and 72 weeks post-baseline.

Specific Aim 1 (primary): Determine the independent and combined efficacies of Mind and Move on memory performance assessed by neurocognitive tests among women ≥ 65 years of age with CVD.

Specific Aim 2 (secondary): Determine the independent and combined efficacies of Mind and Move on memory-related serum biomarkers (BDNF, VEGF, IGF-1) among women ≥ 65 years of age with CVD.

Specific Aim 3 (exploratory): Evaluate depressive symptoms and genetic factors as potential moderators of the association between changes in target behaviors (physical activity and cognitive activity) and health outcomes (memory performance and relevant serum biomarkers).

The investigators hypothesize that Mind and Move individually will each yield benefits to memory. However, it is hypothesized that the combined MindMoves will have a greater impact than the sum of the individual effects. Findings will provide key knowledge about the ability of practical multi-modal lifestyle interventions to target memory 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)

Primary outcomes:
measure: Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Secondary outcomes:
measure: Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: 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
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Other outcomes:
measure: Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks.
timeFrame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
measure: Apolipoprotein [APOE]- ε4 Allele
timeFrame: Baseline
measure: Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism
timeFrame: Baseline
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: Halloway S, Schoeny ME, Barnes LL, Arvanitakis Z, Pressler SJ, Braun LT, Volgman AS, Gamboa C, Wilbur J. A study protocol for MindMoves: A lifestyle physical activity and cognitive training intervention to prevent cognitive impairment in older women with cardiovascular disease. Contemp Clin Trials. 2021 Feb;101:106254. doi: 10.1016/j.cct.2020.106254. Epub 2020 Dec 29.
citation: Halloway S, Volgman AS, Schoeny ME, Arvanitakis Z, Barnes LL, Pressler SJ, Vispute S, Braun LT, Tafini S, Williams M, Wilbur J. Overcoming Pandemic-Related Challenges in Recruitment and Screening: Strategies and Representation of Older Women With Cardiovascular Disease for a Multidomain Lifestyle Trial to Prevent Cognitive Decline. J Cardiovasc Nurs. 2024 Jul-Aug 01;39(4):359-370. doi: 10.1097/JCN.0000000000001000. Epub 2023 May 11.
citation: Halloway S, Volgman AS, Barnes LL, Schoeny ME, Wilbur J, Pressler SJ, Laddu D, Phillips SA, Vispute S, Hall G, Shakya S, Goodyke M, Auger C, Cagin K, Borgia JA, Arvanitakis ZA. The MindMoves Trial: Cross-Sectional Analyses of Baseline Vascular Risk and Cognition in Older Women with Cardiovascular Disease. J Alzheimers Dis. 2024;100(4):1407-1416. doi: 10.3233/JAD-240100.