Lifestyle Physical Activity and Cognitive Training Interventions

NCT04556305 | Completed Results DMC

• 1 other identifier: 18053104
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  The East Boston Memory Test is a performance-based neurocognitive test. Participants are read a brief story with 12 key elements. The participants are asked to recall elements immediately and again after three-minute delay. Each score (immediate and delayed recall) has a scale of 0-12, with a higher score indicating better cognitive performance. The total score is an average of the two subscores for immediate and delayed recall. The total score has a scale of 0-12, with a higher score indicating better cognitive performance.

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

• Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  The Category Fluency Test is a performance-based neurocognitive test. Participants are asked to generate examples for two semantic categories (animals, fruits/vegetables) in separate 60-second trials. There are two separate scores (number of animals generated, number of fruits/vegetables generated). A minimum possible score is 0, with an infinite possible maximum score, with a higher score indicating better cognitive performance.

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

• Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  The Digit Span Forwards and Backwards Test is a performance-based neurocognitive test. The examiner says a string of numbers (digit span). For Digit Span Forwards, participant recites digit span, gradually increasing in length. Test stops when participant fails to recite digit span of same length twice. For Digit Span Backwards, participant recites digit span backwards. There are two separate scores (Digit Span Forwards correct responses, Digit Span Backwards correct responses). Digit Span Forwards scores can range from 0-16, with higher scores indicating higher cognitive performance. Digit Span Backwards Scores range from 0-14, with higher scores indicating higher cognitive performance. A total score is a sum of the two scores, with a range of 0-30, with higher scores indicating higher cognitive performance.

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

• Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  First, participants are asked to count from 1 to 25 (Part A). For Part B, the person is asked to verbally recite alternating numbers and letters until they reach 13 and the letter M. The possible scores is a combined time to completion of both Part A and B summed. Possible minimum score is "discontinued" due to failure to complete the test (a zero score). The maximum score is 300 seconds. A lower score (fewer seconds) indicates higher cognitive performance.

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

• Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  Participants are asked to memorize and immediately recall in ascending order a series of numbers that gradually increase in length with each trial. Possible scores range from 0-16, with a higher score indicating higher cognitive performance.

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

Secondary Outcomes (8)

• Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

• Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

• Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

• Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

• Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

Other Outcomes (3)

• Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks.

  Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

• Apolipoprotein [APOE]- ε4 Allele

  Baseline

• Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism

  Baseline

Study Arms (4)

Mind - BrainHQ cognitive training intervention

EXPERIMENTAL

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.

Behavioral: Mind

Move - lifestyle physical activity intervention

EXPERIMENTAL

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.

Behavioral: Move

MindMoves - cognitive training and lifestyle physical activity

EXPERIMENTAL

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.

Behavioral: Mind; Behavioral: Move

Usual Care

NO INTERVENTION

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.

Interventions

Mind BEHAVIORAL

See arm description.

Mind - BrainHQ cognitive training intervention; MindMoves - cognitive training and lifestyle physical activity

Move BEHAVIORAL

See arm description.

MindMoves - cognitive training and lifestyle physical activity; Move - lifestyle physical activity intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

• 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.

  PMID: 33383230 BACKGROUND

• 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.

  PMID: 37167428 RESULT

• 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.

  PMID: 39031356 RESULT

• Rogers CA, Yeager C, Schoeny M, Wilbur J, Vispute S, Pressler SJ, Arvanitakis Z, Halloway S. Cognitive Training Intervention Adherence in Older Women with Cardiovascular Disease: A Secondary Analysis of the MindMoves Trial. J Cardiovasc Nurs. 2026 Mar-Apr 01;41(2):E63-E69. doi: 10.1097/JCN.0000000000001291. Epub 2025 Dec 22.

  PMID: 41418039 DERIVED

• Halloway S, Schoeny ME, Arvanitakis Z, Volgman AS, Pressler SJ, Vispute S, Wilhelm K, Borgia JA, Wilbur J, Barnes LL. A multidomain trial for cognition in women with cardiovascular disease. Alzheimers Dement. 2025 Jun;21(6):e70285. doi: 10.1002/alz.70285.

  PMID: 40511694 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Shannon Halloway
• Organization: University of Illinois Chicago

sthallow@uic.edu

(312) 996-7800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 21, 2020
• Study Start: October 5, 2020
• Primary Completion: January 12, 2024
• Study Completion: July 31, 2025
• Last Updated: December 3, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-11

Locations

US (1)