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临床试验/NCT06769022
NCT06769022已完成不适用

Exercise Adherence and Cognitive Decline: Engaging With the Black Community to Develop and Test a Goal-Setting and Exercise Intensity Intervention

University of Colorado, Boulder6 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年10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
已完成
入组人数
21
试验地点
6
主要终点
Blood Pressure

研究概览

简要总结

The purpose of this study is to conduct a small-scale test of a goals-based program to help people to exercise more and learn what people like or don't like about the procedures. This program is being designed for individuals aged 45-65 from the Black community. Low levels of physical activity are related to health problems such as heart disease, diabetes, and cognitive decline. People of color are more negatively impacted by these conditions and have also historically been underrepresented by research seeking to increase physical activity. The investigators have developed this goals-based exercise promotion program with the help of a Black-led community-based organization (The Gyedi Project) and a Community Advisory Board made up of stakeholders in the Black community, and now the investigators are conducting a trial of its feasibility and acceptability.

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
None

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • <3 incorrect responses on the Pfeiffer Mental Status Questionnaire
  • Consent to be randomized to condition.
  • Planning to remain in the Denver metro area for the next two months
  • Identify as Black or African American

排除标准

  • Currently physically active (i.e., >90 min/week of moderate PA or >40 min/week of vigorous PA consistently for the past 6 months).
  • On antipsychotic medications or currently under treatment for any serious psychiatric disorder, including Alzheimer's or dementia
  • Answers "yes" to 1 or more of the 7 questions of the PAR-Q+
  • Blood pressure at baseline or before exercise is greater than 140/90
  • Blood pressure >210/90 mmHg (for men) or >190/90 mmHg (for women) immediately after exercise
  • Inability to walk 3 blocks without chest pain, shortness of breath, or light headedness.
  • Inability to climb 2 flights of stairs without chest pain, shortness of breath, or light headedness.

研究组 & 干预措施

Moderate Intensity Exercise, Challenging Goal Difficulty

Experimental

Participants are assigned to exercise at a moderate intensity and create challenging goals.

干预措施: Goal Setting and Exercise Intensity Intervention (Behavioral)

Vigorous Intensity Exercise, Basic Goal Difficulty

Experimental

Participants are assigned to exercise at a vigorous intensity and create basic goals.

干预措施: Goal Setting and Exercise Intensity Intervention (Behavioral)

Moderate Intensity Exercise, Basic Goal Difficulty

Experimental

Participants are assigned to exercise at a moderate intensity and create basic goals.

干预措施: Goal Setting and Exercise Intensity Intervention (Behavioral)

Vigorous Intensity Exercise, Challenging Goal Difficulty

Experimental

Participants are assigned to exercise at a vigorous intensity and create challenging goals.

干预措施: Goal Setting and Exercise Intensity Intervention (Behavioral)

结局指标

主要结局

Blood Pressure

时间窗: Baseline, Visit 14 (~2 months after baseline)

Blood pressure of all participants is collected before intervention

Activity Levels

时间窗: Baseline, Visit 14 (~2 months after baseline)

Exercise Intensity (PAR). Answers are direct (ex. how many hours active) and not scaled. Information is requested for the week and the past 3 months.

Sleep levels

时间窗: Baseline, Visit 14 (~2 months after baseline)

Exercise Intensity (PAR). Answers are direct (ex. how many hours did you sleep) and are not scaled. Information is requested for the past 7 days.

Physical Activity Recall

时间窗: Baseline, Visit 14 (~2 months after baseline)

Exercise Intensity (PAR). Answers are direct (ex. how many hours did you sleep) and are not scaled. Information is requested for the past 7 days.

Identity

时间窗: Baseline

Multidimensional Black Identity Scale to collect information on identity. Questions are about personal identity relating to the Black community on a scale of 1-7, 1 being strongly disagree and 7 being strongly agree. Higher scores indicate a stronger agreement with that dimension of Black identity. Scores are summed as subscales and averaged to obtain an average score.

Heart Rate Variability

时间窗: Baseline, Visit 14 (~2 months after baseline)

Heart Rate Variability is measured using chest strap monitor.

Heart Rate

时间窗: Baseline, Visits 1-14 (all visits)

HR is measured using chest strap monitor.

Exercise Behavior

时间窗: Baseline, Visit 14 (~2 months after baseline)

CHAMPS. The survey collects quantitative data looking at the approximate total hours per week spent doing various activities, both physical and social.

Physical Performance

时间窗: Baseline, Visit 14 (~2 months after baseline)

Short Physical Performance Battery. Physical performance measured with repeated chair stands, three balance tests (side-by-side, semi-tandem, tandem), timed walking.

Ventilatory Threshold

时间窗: Baseline

Talk Test. Graded treadmill test where intensity is increased at intervals to determine participant's ventilatory threshold.

Perceived Exertion

时间窗: Visit 2-13 (~2 visits/week)

A single-item measure from Borg (1973) was used to assess participants' rate of perceived exertion (RPE) during the exercise bout. Participants were asked to rate the average intensity of exercise \[at that moment/during the past ten minutes\] on a 25-point scale ranging from 6 (no exertion at all) to 20 (maximal exertion).

Pain Levels

时间窗: Visit 2-13 (~2 visits/week)

A single item measure from Borg (1998) was used to assess participants' pain levels during the exercise bout. Participants were asked to indicate how much pain they felt \[at that moment/during the past ten minutes\] on an 11-point scale ranging from 0 (nothing at all) to 10 (excruciating).

Affective Valence

时间窗: Visit 2-13 (~2 visits/week)

The Feeling Scale, a single-item measure from Hardy and Rejeski (1989), was used to assess participants' affective valence during the exercise bout. Participants were asked to indicate how they felt \[at that moment/during the past ten minutes\] on an 11-point scale ranging from -5 (very bad) to +5 (very good).

Affective Arousal

时间窗: Visit 2-13 (~2 visits/week)

The Felt Arousal Scale, a single-item measure from Svebak and Murgatroyd (1985), was used to assess participants' affective arousal during the exercise bout. Participants were asked to indicate how "worked-up" they felt \[at that moment/during the past ten minutes\] on a 6-point scale ranging from 1 (low arousal) to 6 (high arousal).

Enjoyment

时间窗: Visit 2-13 (~2 visits/week)

A single item measure from Gillman and Bryan (2015) was used to assess participants' enjoyment levels during the exercise bout. Participants were asked to indicate how enjoyable exercise was \[at that moment/during the past ten minutes\] on a 5-point scale ranging from 1 (no enjoyment at all) to 5 (a great deal of enjoyment).

Exercise Check-In

时间窗: Daily between visit 13 and 14 (~1 month)

Three short questions assessing if the participant planned to engage in exercise and how many minutes of moderate (0-120) and vigorous (0-60) exercise they engaged in

Study Feedback

时间窗: Visit 14 (~2 months after baseline)

An investigator led interview to pilot study participants' experience of the intervention and suggestions for improvement

Exercise Benefits and Barriers

时间窗: Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)

A 10 item scale assessing perceived benefits of and barriers to exercise

Anthropometrics

时间窗: Baseline

Height, weight, waist circumference, and hip circumference will be measured

Exercise Aligned with Black Identity

时间窗: Baseline

Assessment of the extent to which 7 common exercises are aligned with Black identity

Mental Status

时间窗: Baseline

Pfeiffer Mental Status. Assessment of cognitive deficits at baseline.

Physical Activity

时间窗: Baseline

Godin Survey. This survey measures time spent in moderate, strenuous or light activity and has been modified to include time spent sitting over a typical 7 day period. Scores are summed and a range is used to quantify how active/sedentary a participant is.

Theoretical Mediators of Exercise Behavior

时间窗: Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)

Intrinsic Motivation Inventory. Questions relate to how participants think or feel about physical activity, with answers ranging from 1 (strongly disagree) to 7 (strongly agree). Broader scores are broken up into subscales; final subscale scores are summed and averaged. Higher scores indicate higher agreement with that subscale.

Diet

时间窗: Baseline

Nutrition Data System for Research (NDSR) 24-Hour Dietary Recall. Interviewer administered recall developed by the University of Minnesota Nutrition Coordinating Center (NCC).

次要结局

  • Demographics(Baseline)

研究者

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

Angela Bryan

PI

University of Colorado, Boulder

研究点 (6)

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