- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05138809
Evaluation of the Lakeshore Online Fitness Program
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Homewood, Alabama, United States, 35209
- Lakeshore Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
Use online exercise platform
|
Use online exercise platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Level of Physical activity from baseline at 8 weeks
Time Frame: Before and after 8 weeks of participation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Reasons for exercise from baseline at 8 weeks
Time Frame: Before and after 8 weeks of participation
|
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
|
|
Change in Self-efficacy for exercise from baseline at 8 weeks
Time Frame: Before and after 8 weeks of participation
|
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
|
|
Change in Outcome expectations for exercise from baseline at 8 weeks
Time Frame: Before and after 8 weeks of participation
|
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
|
|
Change in Exercise goals/plans from baseline at 8 weeks
Time Frame: Before and after 8 weeks of participation
|
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
|
|
Change in Health-related quality of life from baseline at 8 weeks
Time Frame: Before and after 8 weeks of participation
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mohanraj Thirumalai, PhD, University of Alabama at Birmingham
- Principal Investigator: Tapan Mehta, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB-300007405
- 90REGE000 (Other Grant/Funding Number: NIDILRR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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