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临床试验/NCT03580551
NCT03580551已完成不适用

Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Participants' rating of the program

研究概览

简要总结

The purpose of this study is to investigate the practicality of a short-term (8-weeks), home-based digital versatile disc (DVD) chair exercise program among 40 sedentary older Black/African American and White/Caucasian veterans with three or more chronic health conditions, such as type 2 diabetes, hypertension, and osteoarthritis.

详细描述

This study will determine the feasibility of a home-based DVD chair exercise program, "Sit and Be Fit." Participants will be asked to complete a chair-exercise program Monday through Friday. Each chair exercise session lasts approximately 30 minutes. Participants will receive a new DVD player, the exercise DVD, and the necessary exercise equipment to complete each session. The equipment includes a set of 1 pound hand weights, a 10" exercise ball, a small handball, a resistance band, an exercise log, and a satisfaction survey. Upon initial enrollment, both groups will receive a baseline health assessment that will include health-related quality of life, subjective well-being, body mass index (BMI), comorbidity, blood pressure, lower body extremity fitness, physical activity, and hand grip strength. Excluding health status, all other measures will be completed at post-assessment (the end of week 8 for Group A and Group B). The intervention group (Group A) will receive the equipment after completing eligibility screening, an informed consent, and health assessments. The waitlist control group (Group B) will receive the equipment at week 9 after the post-assessment. Group B will complete the program through week 16. The waitlist control group(Group B) will not receive an additional post assessment at the end of week 16.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be a veteran, which will be verified through documentation, such as discharge papers, military identification card, or military photographs
  • Identify as Black/African American or White/Caucasian; demonstrate proof of age 65+; self-report of three or more chronic health conditions
  • Pass a cognitive screening related to thinking/reasoning/decision making; report less than 30 minutes of daily physical activity
  • Systolic blood pressure lower than 180
  • Diastolic blood pressure lower than 100
  • Resting heart rate 90 or lower
  • Three or more chronic health conditions
  • Permission from primary care physician (PCP)
  • Own a sturdy stand-alone chair without arms
  • Own an operable television
  • Willing to be randomized to the intervention or the waitlist control group

排除标准

  • Non-veteran
  • Non-Black or African American/White or Caucasian
  • Younger than 65 years of age
  • Systolic blood pressure 180 or higher
  • Diastolic blood pressure is 100 or higher
  • Resting heart rate higher than 90
  • Less than three chronic health conditions
  • Failure to pass a cognitive screening
  • Report more than 30 minutes of daily physical activity
  • No approval from PCP
  • No sturdy stand-alone chair without arms
  • No operable television
  • Unwilling to be assigned to the intervention or the waitlist control group

结局指标

主要结局

Participants' rating of the program

时间窗: Week 10

Intervention group participants' ratings of the intervention based on open-ended questions asked during the focus group session.

Number of fitness sessions completed based on participants' activity logs - Adherence to the home-based DVD chair exercise program

时间窗: At the end of 8 weeks.

Adherence (number of fitness sessions completed based on participants' activity logs). Participants' activity logs will be used to assess subjective completion of fitness sessions.

Number of participants lost to attrition

时间窗: At the end of 8 weeks.

The number of participants lost to attrition (dropped out). This will be measured by the number of participants that have completed the entire 8 week program. Before and after each session, participants will be instructed to record the date and time the session was started and completed.

Participants' program satisfaction

时间窗: At the end of 8 weeks.

Satisfaction ratings will be assessed based on participants' satisfaction logs.

次要结局

  • To evaluate the Quality of Life (QOL) of participants(Baseline and post-assessment at week 8.)
  • Physical Activity(Baseline and post-assessment at week 8.)
  • Body Mass Index (BMI)(Baseline and post-assessment at week 8.)
  • Hand Grip Strength(Baseline and post-assessment at week 8.)
  • Short Physical Performance Battery (SPPB)(Baseline and post-assessment at week 8.)
  • Comorbidity(Baseline)
  • Blood pressure(Baseline and post-assessment at week 8)
  • Heart Rate (Pulse)(Baseline and post-assessment at week 8)
  • Subjective Well-being (SWB)(Baseline and post-assessment at week 8.)

研究者

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

Karlene K Ball

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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