CClinicalTrials.gg
CompletedNCT05138809Updated May 21, 2024

Evaluation of the Lakeshore Online Fitness Program

An interventional study of Exercise in Physically Disabled, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Physically Disabled

Keywords

  • Exercise
  • Physical Activity
  • Virtual Exercise
  • Mobility Impairment
03

In context

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • No access to internet
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Exercise

    Use online exercise platform

    Behavioral: Exercise

Interventions

  • BehavioralExercise

    Use online exercise platform

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before and after 8 weeks of participation

Secondary outcomes

  1. 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).

    Time frame: Before and after 8 weeks of participation

  2. 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.

    Time frame: Before and after 8 weeks of participation

  3. 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)

    Time frame: Before and after 8 weeks of participation

  4. 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.

    Time frame: Before and after 8 weeks of participation

  5. 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.

    Time frame: Before and after 8 weeks of participation

07

Study locations

1 site
  • Lakeshore Foundation
    Homewood, Alabama 35209, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05138809
Lead sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation
Responsible party
Tapan Shirish Mehta (Associate Professor and Director of Research, Department of Health Services Administration, University of Alabama at Birmingham) — Principal investigator
First posted
Dec 1, 2021
Start date
Sep 22, 2021
Primary completion
May 2, 2022
Completion
May 2, 2022
Last update
May 21, 2024

Study contacts

Tapan Mehta, PhD
principal investigator · University of Alabama at Birmingham
Mohanraj Thirumalai, PhD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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