Evaluation of the Lakeshore Online Fitness Program

Physically Disabled Clinical Trial

Official title:

Evaluation of the Lakeshore Online Fitness Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138809
• Other study ID #: IRB-300007405
• Secondary ID: 90REGE000
• Status: Completed
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: May 2, 2022

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physically Disabled

Intervention

Behavioral:
• Exercise
Use online exercise platform

Locations

Country	Name	City	State
United States	Lakeshore Foundation	Homewood	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Lakeshore Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Level of Physical activity from baseline at 8 weeks	Assess current level of physical activity. Godin Leisure-Time Exercise Questionnaire. Four questions, score ranges from 0 to 119. A higher score indicates higher level of physical activity.	Before and after 8 weeks of participation
Secondary	Change in Reasons for exercise from baseline at 8 weeks	Participant's reasons for exercise (survey). Ten questions, response from 1 to 5 for each question (1 = not important, 5 = very important).	Before and after 8 weeks of participation
Secondary	Change in Self-efficacy for exercise from baseline at 8 weeks	Participant's belief in their ability to exercise. Self-Efficacy for Exercise Scale. Nine questions. score ranges from 0 to 90. A higher score indicates higher self-efficacy for exercise.	Before and after 8 weeks of participation
Secondary	Change in Outcome expectations for exercise from baseline at 8 weeks	What outcomes does the participant expect as a result of exercising. Multidimensional Outcome Expectations for Exercise Scale. Fifteen questions, score ranges from 15 to 75. A higher score indicates higher expectations for exercise outcomes. Also, three subscales: Physical (6 items), Self-evaluation (5 items), and Social (4 items)	Before and after 8 weeks of participation
Secondary	Change in Exercise goals/plans from baseline at 8 weeks	Participant's exercise goals and plans. Exercise Goal-Setting and Planning/Scheduling Scales. Ten questions related to goal setting, score ranges from 10 to 50. A higher score indicates higher goal setting. Ten questions related to exercise planning, score ranges from 10 to 50. A higher score indicates greater exercise planning.	Before and after 8 weeks of participation
Secondary	Change in Health-related quality of life from baseline at 8 weeks	Participant's self-reported quality of life. Enabled version of the short-form 36 (SF-36E). Thirty-six questions, 8 subscales, two summary scores. The scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate greater health-related quality of life.	Before and after 8 weeks of participation