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临床试验/NCT05227105
NCT05227105进行中(未招募)不适用

Increasing Physical Activity in Rural Pennsylvanians: The PA Moves Trial

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2023年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
640
试验地点
2
主要终点
Objective accelerometry

研究概览

简要总结

The purpose of this study is to address physical inactivity in rural populations in Pennsylvania.

详细描述

People living in rural areas are diagnosed and die from cancer at higher rate than people living in cities. Physical activity has been shown to decrease the risk and occurrence of a variety of cancers, including bladder, breast, colon, endometrial, gastric, kidney, and prostate cancers. Being inactive can cause over 10% of breast and colon cancer cases.

Compared to people living in cities, people living in rural areas tend to be less physically active. They're also more likely to be overweight/obese or have diabetes. Adults who are overweight, obese, or diabetic often have changes in the way their bodies deal with insulin, glucose metabolism, and inflammation. Physical activity is thought to reduce the risk of cancer by improving these issues over time.

Primary care providers and their staff can identify a patient's need for more physical activity, but may not have the time or resources to give advice or assistance. We have set up a telephone-based physical activity coaching program, called the MoveLine, to give inactive patients advice and assistance in becoming more physically active.

The purpose of this study is to determine if referring inactive patients to the MoveLine will help them to be more physically active over time. Approximately 880 people will take part in this research in rural areas of Pennsylvania.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 - 75 at the time of enrollment
  • Either overweight/obese (Body Mass Index (BMI) ≥ 25) or diabetic (hemoglobin A1c ≥ 5.7%)
  • Physically inactive (defined as < 90 min/week of self-reported structured physical activity)
  • Able to speak, read, and understand the English language
  • Resides in a rural area of Pennsylvania with a Rural Urban Continuum Code (RUCC) 4 - 9 or Rural-Urban Commuting Area (RUCA) code 4 - 10
  • Must be able to provide and understand informed consent
  • Primary care patient of one of the participating providers
  • Self-report ability to walk ¼ mile
  • Access to a telephone

排除标准

  • Cardiac exclusion criteria: Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system, history of acute coronary syndromes, uncertain or uncontrolled arrhythmia, uncontrolled hypertension, syncope, acute myocarditis, acute pericarditis, acute endocarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, respiratory failure, or acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
  • Mental impairment leading to inability to cooperate, provide informed consent, or follow study instructions
  • Evidence in the electronic medical record of an absolute contraindication for physical activity
  • Severe or advanced orthopedic conditions
  • Use of assistive devices for ambulation
  • Resides outside of a rural area of Pennsylvania (i.e., one that is not RUCC code 4 - 9 OR RUCA code 4 - 10)
  • Pregnant women

研究组 & 干预措施

Physical Activity intervention

Active Comparator

Five physical activity coaching calls with MoveLine and weekly physical activity. Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.

干预措施: Physical Activity (Behavioral)

Delayed intervention

Placebo Comparator

Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.

干预措施: Delayed intervention (Behavioral)

结局指标

主要结局

Objective accelerometry

时间窗: 12 months vs. baseline

An accelerometer will be worn for one week to track physical activity.

Physical Activity Questionnaire

时间窗: 12 months vs. baseline

The 11-question Morgenstern Physical Activity Questionnaire (PAQ-M) is a self-report of physical activity resulting from recreational activities, exercises, home or work activities, and chores.

次要结局

  • Physical Activity Questionnaire(24 months vs. baseline; 24 months vs. 12 months)
  • Objective accelerometry(24 months vs. baseline; 24 months vs. 12 months)

研究者

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

Kathryn Schmitz

Professor

University of Pittsburgh

研究点 (2)

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