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临床试验/NCT05670223
NCT05670223已完成不适用

Healthy Activities Improve Lives

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年9月30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
36
试验地点
2
主要终点
Acceptability

研究概览

简要总结

The investigators have developed an online platform to support the 8-week, F&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aims of this study are to conduct an open pilot trial with exit interviews (N=30) of the HAIL online platform in two racially diverse churches to evaluate its feasibility and acceptability (Hypothesis 1) as well as explore its efficacy (Hypothesis 2).

详细描述

This is an open pilot study to evaluate the feasibility and accessibility of the HAIL online platform. This study will enroll two cohorts (i.e., at two racially diverse churches) for a total number of 30 participants. This study will use a phone screen to assess participants' eligibility and explain the study procedures. Eligible individuals will then be given a link to complete an e-Consent in REDCap as well as instructions on how to access the HAIL online platform to complete assessments as part of the baseline visit. Participants will complete the 8-week F&S! exercise program (with access to the adjunct HAIL online platform), which will be delivered in-person as well as remote, and then continue to use the HAIL online platform during the 3-mo follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Individuals over the age of 60 years
  • Participants are able to travel to one of the churches for the in-person F&S! exercise sessions
  • Participants cannot be currently participating in a regular PA (physical activity) program (i.e., at least 100 min per week of moderate to vigorous physical activities)

排除标准

  • Participants do not understand study procedures or are unable to participate in the verbal consent process
  • Participants must have a physician responsible for their medical care
  • Participants endorse an item on the Revised Physical Activity Readiness Questionnaire (rPAR-Q) as confirmed by their treating physician
  • Participants who report any contraindication to exercising (e.g., recent ECG changes or myocardial infarction, unstable angina, uncontrolled arrhythmias, third degree heart block, congestive heart failure)

结局指标

主要结局

Acceptability

时间窗: Week: 20

Acceptability will be assessed by :1) Client Satisfaction Questionnaire (CSQ-8), 2) F\&S! - online Feedback form, 3) Focus group exit interviews. The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity. We will develop a form to ask for tailored feedback on the F\&S-Online program to better understand participants' satisfaction with specific aspects of this online program. We will also conduct exit interviews with focus group and pilot study participants

Feasibility and Retention

时间窗: Week: 20

Retention will be assessed by how many people completed the 3-month post-intervention follow-up

次要结局

  • Changes in Aerobic Capacity(Weeks: 0 , 8 , 20)
  • Utilization of Healthcare Resources(Weeks: 0)
  • Changes in Physical Strength(Weeks: 0 , 8 , 20)
  • Motivation to Change(Weeks: 0)
  • Changes in Anxiety(Weeks: 0, 8 , 20)
  • Fall History(Weeks: 0)
  • Changes in Physical Functioning(Weeks: 0, 8 , 20)
  • Changes in Confidence in Exercises(Weeks: 0, 8 , 20)
  • Chronic Conditions(Weeks: 0)
  • Changes in Overall Wellbeing(Weeks: 0, 8 , 20)
  • Changes in Depression(Weeks: 0, 8 , 20)
  • Changes in Social Isolation(Weeks: 0, 8 , 20)

研究者

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

Louisa Grandin Sylvia

Principal Investigator

Massachusetts General Hospital

研究点 (2)

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