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临床试验/NCT06884501
NCT06884501尚未招募不适用

Let's Increase Fuerza (Strength) Through Exercise and Diet

University of Illinois at Urbana-Champaign0 个研究点目标入组 90 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
主要终点
Trail Making Test (A&B)

研究概览

简要总结

The purpose of the study is to conduct a 6-month randomized controlled trial among Latinos ages 50+ at risk for cognitive decline and compare the efficacy of a remote-delivered, culturally tailored Latin dance program and strength training coupled with a Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet (IG) compared to a Latin dance and MIND diet program (CG) on cognitive performance, CVD risk factors, MIND diet adherence, physical activity, biomarkers, and psychosocial outcomes.

Participants will:

  • Randomly be placed in the intervention (IG) or control group (CG)
  • Have 2 pre and post intervention testing visits
  • Have weekly sessions during the 6-month trial

详细描述

Screening and Consent: Potential participants can consent to be screened via email or by calling our office to be screened. Study staff will screen all interested individuals for eligibility based on inclusion/exclusion criteria. Participants will be administered the Exercise and Screening for You (EASY) tool. The EASY tool consists of 6 questions to assess one's risk factors associated with exercise. Depending on how participants respond to the 6 questions, they may need to obtain medical clearance to participate in the study.

To obtain medical clearance, we will ask interested participants for the name and contact information of physician. We will send a letter via email or fax to the physician requesting medical clearance. Once we receive medical clearance vi email or fax, we will then begin the Informed Consent process. Once determined eligible, study staff will email Qualtrics link to Informed Consent and will go over the consent form. Participants will be instructed to save/print a copy of the document for their records. After participants have signed the Informed Consent, they will be invited to the first testing session at Freer Hall at the University of Illinois at Urbana-Champaign.

Baseline first testing session (~2 hours): At the first testing session, research personnel will collect demographics, health history, self-reported physical activity (Godin & non-exercise measure of cardiorespiratory fitness), and the Food Frequency Questionnaire will be administered. Anthropometrics such as height, weight, blood pressure, waist circumference, and DEXA scan will also be conducted.

Trained research staff will guide the participant through drop sets (increasing weight with decreasing repetitions) with 10 reps (2lbs), 8 reps (3lbs), 6 reps (5lbs), and 4 reps (8lbs) for the following exercises: Dumbbell overhead press, dumbbell squat, dumbbell single arm row, dumbbell deadlift, seated dumbbell chest fly, and dumbell side lunges. We will have participants begin with light weights and slowly progress with heavier weights (if possible, otherwise participants will stick to lighter weights). These exercise have been chosen for the baseline and posttesting because they are reflective of the exercise that they wil do at home.

Participants will be provided with an accelerometer and the accelerometer log. Participants will be asked to wear the accelerometer for 7 consecutive days. Participants will be asked to wear the monitor on a belt or attached to a clip placed on their non-dominant hip during wake times only. They will be asked to remove the monitor during any water-related activities and sleep. Accelerometer-wearing instructions and logs will be provided to participants. After the 7 days, participants will be scheduled for their second visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •self-identify as a Latino/Hispanic, 2) age 50+, 3) documented cardiovascular disease (CVD) or at least one CVD risk factor (i.e., hypertension, hyperlipidemia, diabetes, obesity, current smoker, or family history of CVD), 3) participate in <3 days or <90 minutes of moderate-to-vigorous PA per week, 4) able to understand Spanish, 5) Wi-Fi Access, 6) score of greater than 21 on the TICS-M

排除标准

  • •uncontrolled illness including diabetes (e.g., participant reports high glucose levels despite treatment efforts), hypertension (e.g., participant is hypertensive while on medication or not adhering to medication), or thyroid disease (e.g., patient reports experiencing hyperthyroidism).
  • •history of musculoskeletal, cardiorespiratory, or neurological diseases that preclude the participation in moderate intensity exercise

研究组 & 干预措施

Intervention Group

Experimental

Remote-delivered BAILAMOS™ dance program, MIND diet & strength training

干预措施: Latin dance, MIND diet, and Strength training (Behavioral)

Control Group

Active Comparator

Remote-delivered BAILAMOS™ dance program and MIND diet

干预措施: Latin dance and MIND Diet (Behavioral)

结局指标

主要结局

Trail Making Test (A&B)

时间窗: Change in scores from baseline to post-intervention 6 months

Trail Making Test (A\&B) will be used to measure executive function. Part A consists of numbers spread out in a grid with a dedicated start and end point. Participants must trace in sequential order. Part B will consist of numbers and letters in sequential order spread across a grid with a start and end point as well. Participants much trace the starting number to letter. Scoring will be based on seconds needed to complete each test with Part A having a max of 100 seconds and Part B with a max of 300 seconds. Test will discontinue when the time limit has been reached.

Stroop Neuropsychological Screening Test (Trennerry et al., 1989)

时间窗: Change in score from baseline to 6 months

Stroop Test will be used to assess executive function. In Stroop C, participants are shown a list of colors printed in conflicting color ink and are asked to read words (names of colors). The second part of this task is Stroop CW in which participants are shown a list of colors printed in conflicting color ink and are asked to say the color of the ink the word is printed. The scores are the number of words named correctly in 30 seconds and the number of colors named correctly in 30 seconds subtracting the number of errors. respectively.

Word fluency Test (Welsh et al., 1994)

时间窗: Change in score from baseline to 6 months

Word Fluency will be used to assess executive function. The Word Fluency Test asks participants to name as many animals (part 1) or fruits and vegetables (part 2) as possible in 60 seconds. The score is the sum of the number of animals and the number of fruits and vegetables named.

Digit Span Test (Wechsler, 1987)

时间窗: Change in score from baseline to 6 months

Digit Span Test will be used to measure executive function. Digit Span Forward \& Backward will be used to assess working memory. Digit strings of increasing length will be read, and the participant is asked to repeat each string forward (Digit Span Forward) or backward (Digit Span Backward). The score is the number of correctly retrieved strings in each part

次要结局

  • Minutes per day of light and moderate-to-vigorous physical activity via GT3x Actigraph Accelerometer(Change in minutes per day of light and moderate-to-vigorous physical activity from baseline to post-intervention 6 months)
  • Godin-Shephard Leisure-Time Physical Activity Questionnaire(Change in score from baseline to 6 months)
  • Non-exercise Cardiorespiratory Fitness Questionnare(Change in score from baseline to 6 months)
  • Fasting Blood glucose(Change from baseline to post-intervention 6 months)
  • Spectroscopy-Based Veggie Meter®(Change in scores from baseline to post-intervention 6 months)
  • Plasma Structural Lipidomics(Change in scores from baseline to post-intervention 6 months)
  • National Institutes of Health (NIH) Toolbox: Perceived Stress Fixed Form Age 18+ v2.0(Change in scores from baseline to post-intervention 6 months)
  • National Institutes of Health (NIH) Toolbox General Life Satisfaction Fixed Form A Age 18+ v2.0(Change in scores from baseline to post-intervention 6 months)
  • National Institutes of Health (NIH) Tool Box: Sadness Fixed Form Age 18+ v2.0(Change in scores from baseline to post-intervention 6 months)
  • National Institues of Health (NIH) Toolbox Loneliness Fixed Form Age 18+ v2.0(Change in scores from baseline to post-intervention 6 months)
  • MIND Diet Adherence(Change in scores from baseline to post-intervention 6 months)
  • Blood pressure(Change from baseline to post-intervention 6 months)
  • Waist Circumference(Change from baseline to post-intervention 6 months)
  • DEXA(Change from baseline to post-intervention 6 months)
  • MOCA-Blind Version 8.1(Change in score from baseline to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Aguinaga

Assistant Professor

University of Illinois at Urbana-Champaign

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