Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Perspectives on study interventions
研究概览
简要总结
The aim of this study is to assess the feasibility and acceptability (e.g., enrollment, adherence, retention, acceptability of procedures and interventions) of a pilot factorial study design that will help elucidate components of mind-body exercise interventions. The study involves completing a walking program, a mindful attention program, a walking program that includes mindful attention, or no program at all. A "pilot" study is a smaller study that helps researchers to understand whether the study design can be carried out and what participants think about the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metabolic syndrome, defined as meeting 3 or more of the following criteria in the last 12 months at the time of medical record review: (a) BMI ≥ 25; (b) fasting glucose ≥ 100 [5.6 mmol/L] or A1C ≥ 5.7 or medications; (c) blood pressure ≥ 130 systolic or ≥ 85 diastolic or medications; (d) triglycerides ≥ 150 or 1.7 mmol/L or medications; (e) or HDL < 40mg/ dL for men and 50mg/dL for women or medications;
- •insufficiently active, defined as a score ≤ 23 (moderate-to-strenuous units) on Godin-Shepard Leisure-Time Physical Activity Questionnaire;
- •age 18-70 years;
- •given medical clearance for moderate-intensity exercise and exercise stress testing by their primary care physician (PCP);
- •access to a device with internet and videoconferencing capabilities
排除标准
- •current diagnosis of any of the following: (a) coronary artery disease or other chronic heart diseases (e.g., heart failure) in which exercise would be contraindicated or that would preclude HRV analyses (e.g., some arrhythmias); (b) any diabetes; (c) chronic obstructive pulmonary disease or other severe lung dysfunction (e.g., severe asthma); (d) severe cognitive impairment
- •>2 self-reported classes or self-guided mindfulness or mindful movement sessions per week in past 3 months
- •self-reported inability to speak and read in English
- •current beta blocker or calcium channel blocker medication
- •uncontrolled hypertension, defined as resting blood pressure ≥ 150 systolic or ≥ 90 diastolic in the last 6 months
- •self- or physician-reported contraindications for exercise (e.g., severe balance impairment, musculoskeletal restrictions)
研究组 & 干预措施
Mindful attention
16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones
干预措施: Mindful attention (Other)
Exercise
16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking
干预措施: Exercise (Other)
Exercise with mindful attention
16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones
干预措施: Exercise with mindful attention (Other)
No intervention
No intervention sessions
结局指标
主要结局
Perspectives on study interventions
时间窗: Post-intervention (after 8 week intervention)
Perspectives on study interventions will be assessed via exit interview
Feasibility of screening: screened to eligible ratio
时间窗: Through study completion, an average of 1 year
percent of screened individuals that were determined eligible for the study
Feasibility of retention: retention at each assessment
时间窗: 6 months
percent of enrolled participants retained at post-intervention and 3-month follow-up; determined to be feasible if greater than or equal to 70% retention at each assessment
Feasibility of interventions: attendance rates for each session
时间窗: 6 months
percent session attendance; determined to be feasible if participants attend greater than or equal to 75% of sessions
Feasibility of survey completion: survey completion rates at each assessment
时间窗: 6 months
percent of participants that complete surveys at post-intervention and 3-month follow-up
Acceptability of interventions
时间窗: 6 months
Acceptability of the interventions will be assessed via overall satisfaction (1 = not at all to 10 = very much); determined to be acceptable if mean rating is greater than or equal to 7.5 across 80% of sessions
Feasibility of enrollment: eligible to enrollment ratio
时间窗: Through study completion, an average of 1 year
percent of eligible individuals that enroll in the study; determined to be feasible if greater than or equal to 70% of eligible patients enroll
Acceptability of study design
时间窗: 6 months
Acceptability of the study design will be assessed via acceptability of study procedures (1= not at all to 10 = very much); determined to be acceptable if mean rating is greater than or equal to 7.5 across 80% of sessions
次要结局
- Heart rate dynamics(Baseline (week 0), post-intervention (after 8 week intervention))
- Emotion regulation(Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention)
- Ventilatory efficiency(Baseline (week 0), post-intervention (after 8 week intervention))
- Positive affect(Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention)
- Interoceptive awareness(Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention)
- In-session oxygen consumption(Weeks 1 and 8)
- In-session respiration rate(Weeks 1 and 8)
- Self-efficacy(Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention)
- Self-reported physical activity(Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention)
- In-session heart rate(Weeks 1 and 8)
- In-session ventilatory efficiency(Weeks 1 and 8)
- Objective physical activity(Baseline (week 0), post-intervention (after 8 week intervention))
研究者
Kristen Kraemer
Instructor of Medicine
Beth Israel Deaconess Medical Center