Clinical trial NCT05138809: Evaluation of the Lakeshore Online Fitness Program
Official title: Evaluation of the Lakeshore Online Fitness Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physically Disabled
Keywords: Exercise
Physical Activity
Virtual Exercise
Mobility Impairment
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Lakeshore Foundation
First posted: 2021-12-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to test feasibility of an online platform that delivers virtual exercise programs for individuals with physical disabilities.

Detailed description: The sample pool of this study is members of a community fitness center that serves individuals with physical disabilities and chronic health conditions. The study will be advertised to the members through flyers, newsletters, social media, and center's website.

Members logging into the center's online exercise system will be presented with a brief introduction to the study and asked if they would like to "Opt In" to receive further information. When the system receives on Opt In trigger, the member will be asked a series of eligibility screening questions regarding their age, fluency in English, and whether or not they have a mobility limitation or problems with gait, balance, and/or coordination. Members who are not eligible will be directed back to center's online exercise system for regular access to the program options. Members who are eligible will be asked to complete an e-Consent form. Members who decline consent will be directed back to the center's online exercise system for regular access to the program options. Members who accept consent will be provided with a welcome page listing next steps.

After review of the welcome page, participants will be asked to complete a series of online surveys that will be completed before and after 8 weeks of participation. All surveys, except for the health history, are composed of Likert-scale questions. After the participant completes all the surveys, the system will trigger a message to the research staff to schedule an onboarding call with the participant to provide an overview of the system and available online classes (live and pre-recorded). Participants will be encouraged to accumulate a total of 150 minutes of moderate or 75 minutes of vigorous exercise throughout the week.

Participants will then be on their own to participate in virtual classes as they wish. Each time the participant completes a live online class, they will be asked to complete a brief survey to provide their perceptions regarding the class. Compensation in the form of a gift card will be provided to participants for completion of the Pre and Post intervention surveys. In addition, small incentives will be provided to the participants meeting certain participation criteria.

At the end of each week, the research staff will monitor logins and post-class survey responses. In the event that a participant has not logged into the system during the past 7 days or indicates issues via the post class survey a member of the research team will call them. Coaching calls will be made at the end of Week 2, 4, and 6 as needed. If the issue is lack of interest or difficulty with the existing classes, a new series of pre-recorded exercise videos will be made available to the participant for remainder of the eight weeks. This option will only be available once. At the end of the 8 weeks, participants will be asked to complete the survey package again.

Eligibility criteria: Inclusion Criteria:

* Must be a member of Lakeshore Foundation
* Age 18 years or above
* Mobility limitation, problem with gait, balance and/or coordination
* Fluency in English

Exclusion Criteria:

* No access to internet

Primary outcomes:
measure: Change in Level of Physical activity from baseline at 8 weeks
timeFrame: Before and after 8 weeks of participation
Secondary outcomes:
measure: Change in Reasons for exercise from baseline at 8 weeks
timeFrame: Before and after 8 weeks of participation
measure: Change in Self-efficacy for exercise from baseline at 8 weeks
timeFrame: Before and after 8 weeks of participation
measure: Change in Outcome expectations for exercise from baseline at 8 weeks
timeFrame: Before and after 8 weeks of participation
measure: Change in Exercise goals/plans from baseline at 8 weeks
timeFrame: Before and after 8 weeks of participation
measure: Change in Health-related quality of life from baseline at 8 weeks
timeFrame: Before and after 8 weeks of participation
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Lakeshore Foundation
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Tapan Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Mohanraj Thirumalai, PhD
role: PRINCIPAL_INVESTIGATOR
References: