Exercise From Afar: Progressing At-Risk Rural Adults to Effective Independent Exercise for Dementia Risk Reduction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Determine the impact of a technology-driven exercise program on exercise adherence.
研究概览
简要总结
The purpose of this study is to investigate the efficacy of a technology-driven independent exercise program on health outcomes associated with dementia risk among underactive rural adults.
Underactive adults (n=50), ages 40-70 years, from federally designated rural and frontier Kansas counties will be recruited to participate in this study. Specific inclusionary and exclusionary criteria will be used to screen potential participants and determine eligibility. Following recruitment and screening, participants will complete baseline physical fitness and health assessments, supervised by the research team. Following completion of baseline assessments, a personal training/fitness app will be employed to design and deliver exercise programming and track exercise participation, adherence and progression over the course of the study. All prescribed exercise will follow national governing body recommendations and include specific exercises found in previous work to be beneficial for physical health and brain plasticity. The study team will record exercise instruction videos that can be accessed by all participants at any time throughout the study. The particular app used will allow the research team to organize exercise videos into structured training sessions, allowing participants to exercise on their own, at the location of their choice, with ample instruction. The app will also allow participants to record themselves performing various exercises and send them to the research team for analysis of technique and safety. Communication between study personnel and participants will be delivered via the app. Phone calls and/or Zoom sessions will be offered as an alternative if necessary. Our goal is to create a safe, effective means of delivering personalized exercise programming to rural adults that reduces barriers to exercise, improves physical fitness and biomarkers associated with dementia risk and lends itself to exercise adherence in a population that is at an increased risk for cognitive decline. Middle aged adults will be included in the study as they are at an age when successful behavior change is more probable (than older, institutionalized adults); older adults will be included as they are in the high-risk category for dementia. Following the exercise intervention, all baseline assessments will be repeated. Data will be compared to determine the impact of the exercise program on each variable (i.e. dementia risk biomarkers, QOL, physical fitness, etc.).
详细描述
Following screening, participants will complete baseline physical fitness and health assessments, supervised by the research team. This will require travel by the research team to various rural Kansas locations. The assessments will be those considered reliable, validated 'field tests' and can be easily administered with minimal exercise equipment. Assessments will include a submaximal VO2 field test to assess cardiorespiratory fitness, and an estimated 1 repetition maximum test to assess muscular strength.
Assessments will follow ACSM guidelines for safety and progression for middle aged and older adults.
Blood glucose and cholesterol levels will be measured as well, using a device commonly used in the field (Cholestek LDX ™) This device will assess total blood glucose, cholesterol, LDL, HDL and triglycerides. Additional baseline assessments may include, but are not limited to: a barriers to being active survey (BBAQ) and a perceived stress survey (PSS). All surveys are attached to this application.
Following completion of baseline assessments, participants will be randomized to one of two groups:
- Exercise (EX); This group will be given structured exercise programming for 16 weeks.
- Control (CON); This group will serve as the underactive control for this study. At the end of 16 weeks, they will be offered the same 16-week structured exercise program as the exercise group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants will be aware of which study group they are assigned to. Investigators will also be aware of what study group participants are assigned to.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40 to 70 years of age
- •Characterized as underactive by the TAPA
- •Able to read and converse in English
- •Willing and able to install an application on their smart phone
排除标准
- •Myocardial infarction or symptoms of coronary artery disease in the last 2yrs
- •Uncontrolled hypertension within the last 6 months
- •Cancer in the last 2yrs (except non-metastatic basal or squamous cell carcinoma)
- •Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program
- •Possible/probably dementia or mild cognitive impairment (MCI) base on adjudication
- •Physician concern regarding safety or completion of the study
结局指标
主要结局
Determine the impact of a technology-driven exercise program on exercise adherence.
时间窗: 16 weeks per participant enrolled
Exercise log data will be used to determine exercise adherence. Exercise adherence will be reported as the percentage of total exercise sessions completed over the course of the 16-week exercise study period. Exercise adherence will be tracked and recorded for EX participants only, since CON participants will not complete any exercise during the 16-week study period. The investigators hypothesize that Rural adults will report moderate to high adherence (70-80% total sessions completed) over the course of the study.
Determine the impact of a technology-driven exercise program on barriers to being physical active.
时间窗: 16 weeks per participant enrolled
Participants will complete the BBAQ (Barriers to Being Active Quiz) at baseline and following the 16-week exercise study period (following 16 weeks of intervention or control). The results will be compared to determine statistical differences, if any, in barriers to participating in exercise between time points and between groups (EX vs CON). Participants assigned to the exercise group will log their exercise using the smart phone application for the entire 16-week study period. Higher scores on the BBAQ equate to a greater number of barriers to being active. The investigators hypothesize that Rural adults will report fewer barriers to being active (lower BBAQ scores) following 16 weeks of the technology-driven exercise intervention.
Determine the impact of a technology-driven exercise program on exercise self-efficacy.
时间窗: 16 weeks per participant enrolled
Participants will complete the Exercise Self-Efficacy Scale at baseline and following the 16-week exercise study period (following 16 weeks of intervention or control). The results will be compared to determine statistical differences, if any, between time points and between groups (EX vs CON). The investigators hypothesize that Rural adults will report higher exercise self-efficacy (higher Self-Efficacy Scale scores) following the intervention (compared to CON participants).
Determine the impact of a technology-driven exercise program on cholesterol and fasting blood glucose.
时间窗: 16 weeks per participant enrolled
Fasting blood glucose and cholesterol are measured simultaneously using a Cholestek device. This measure will be completed by all participants at baseline, and again at follow-up (following 16 weeks of intervention or control). The investigators hypothesize that participants in the EX group (exercise intervention) will see greater improvements in total cholesterol, fasting blood glucose and LDL following the intervention, compared to the CON group. The investigators expect that participants with higher exercise adherence will see the greatest improvements in these biomarkers associated with reduced dementia risk.
Determine the impact of a technology-driven exercise program on cardiorespiratory fitness.
时间窗: 16 weeks per participant enrolled
Participants will also complete a common cardiorespiratory field test at baseline and again at follow-up (after 16 weeks of intervention or control). The investigators hypothesize that cardiorespiratory fitness scores will improve for EX participants following the 16-week intervention and that the post-intervention cardiorespiratory field test scores will be significantly better than those of the CON group.
Determine the impact of a technology-driven exercise program on muscular fitness.
时间窗: 16 weeks per participant enrolled
Participants will complete an repetition maximum muscular fitness test at baseline and again at follow-up (after 16 weeks of intervention or control). The investigators hypothesize that muscular fitness will improve for EX participants following the 16-week intervention and that the post-intervention muscular fitness results will be significantly better than those of the CON group.
次要结局
未报告次要终点
研究者
Erin Blocker
PI
Emporia State University