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Clinical Trials/NCT05670223
NCT05670223
Completed
N/A

Healthy Activities Improve Lives

Massachusetts General Hospital1 site in 1 country36 target enrollmentSeptember 30, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Activity
Sponsor
Massachusetts General Hospital
Enrollment
36
Locations
1
Primary Endpoint
Acceptability
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2022
End Date
September 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Louisa Grandin Sylvia

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Acceptability

Time Frame: 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

Time Frame: Week: 20

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

Secondary Outcomes

  • 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)

Study Sites (1)

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