Lifestyle Physical Activity and Cognitive Training Interventions (MindMoves)

Rush

Status: Completed

Conditions: Cognitive Impairment; Mild Cognitive Impairment; Cognitive Decline; Cognitive Dysfunction; Cardiovascular Diseases

Treatments: Behavioral: Move; Behavioral: Mind

Study type: Interventional

Funder types: Other

Identifiers

NCT04556305

18053104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 253 patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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253 participants in 4 patient groups

Mind - BrainHQ cognitive training intervention

Experimental group

Description:

The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.

Treatment:

Behavioral: Mind

Move - lifestyle physical activity intervention

Experimental group

Description:

The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.

Treatment:

Behavioral: Move

MindMoves - cognitive training and lifestyle physical activity

Experimental group

Description:

Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.

Treatment:

Behavioral: Mind

Behavioral: Move

Usual Care

No Intervention group

Description:

Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.