Clinical trial NCT05670223: Healthy Activities Improve Lives
Official title: Healthy Activities Improve Lives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-01-04
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Feasibility and Retention
timeFrame: Week: 20
measure: Acceptability
timeFrame: Week: 0
measure: Acceptability
timeFrame: Week: 8
measure: Acceptability
timeFrame: Week: 20
Secondary outcomes:
measure: Changes in Aerobic Capacity
timeFrame: Weeks: 0 , 8 , 20
measure: Changes in Physical Strength
timeFrame: Weeks: 0 , 8 , 20
measure: Motivation to Change
timeFrame: Weeks: 0
measure: Utilization of Healthcare Resources
timeFrame: Weeks: 0
measure: Fall History
timeFrame: Weeks: 0
measure: Chronic Conditions
timeFrame: Weeks: 0
measure: Changes in Overall Wellbeing
timeFrame: Weeks: 0, 8 , 20
measure: Changes in Depression
timeFrame: Weeks: 0, 8 , 20
measure: Changes in Anxiety
timeFrame: Weeks: 0, 8 , 20
measure: Changes in Physical Functioning
timeFrame: Weeks: 0, 8 , 20
measure: Changes in Social Isolation
timeFrame: Weeks: 0, 8 , 20
measure: Changes in Confidence in Exercises
timeFrame: Weeks: 0, 8 , 20
Other outcomes:
measure: Satisfaction with program
timeFrame: Week: 8
measure: Satisfaction with program
timeFrame: Week: 20
measure: Use of online program
timeFrame: Weeks: 8
measure: Use of online program
timeFrame: Weeks: 20
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Louisa Sylvia, PhD
role: PRINCIPAL_INVESTIGATOR
References: