Physically DisabledNCT05138809
Evaluation of the Lakeshore Online Fitness Program
A study testing Exercise in people with Physically Disabled, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physically Disabled
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 2 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a member of Lakeshore Foundation
- Age 18 years or above
- Mobility limitation, problem with gait, balance and/or coordination
- Fluency in English
Who cannot join
- No access to internet
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Physically Disabled
- Being tested
- Exercise
- Keywords
- Exercise, Physical Activity, Virtual Exercise, Mobility Impairment
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Use online exercise platform
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Use online exercise platform Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after 8 weeks of participation
Secondary outcomes (5)
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).
Measured: Before and after 8 weeks of participation
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.
Measured: Before and after 8 weeks of participation
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)
Measured: Before and after 8 weeks of participation
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.
Measured: Before and after 8 weeks of participation
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.
Measured: Before and after 8 weeks of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start22 Sep 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physically DisabledStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lakeshore Foundation
- Responsible party
- Principal investigator, Tapan Shirish Mehta, University of Alabama at Birmingham
- Investigators
- Tapan Mehta, PhD, Principal investigator, University of Alabama at BirminghamMohanraj Thirumalai, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138809
- Sponsor's protocol ID
- IRB-300007405
- Other IDs
- 90REGE000
- Status last verified
- May 2024
- First submitted
- 2 Sep 2021
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malone LA, Mehta T, Mendonca CJ, Mohanraj S, Thirumalai M. A prospective non-randomized feasibility study of an online membership-based fitness program for promoting physical activity in people with mobility impairments. Pilot Feasibility Stud. 2024 Aug 2;10(1):104. doi: 10.1186/s40814-024-01528-x.
PubMed 39095876
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Lakeshore Online Fitness Program
- ClinicalTrials.gov ID
- NCT05138809
- Acronym / sponsor ID
- IRB-300007405
- Conditions
- Physically Disabled
- Keywords
- Exercise, Physical Activity, Virtual Exercise, Mobility Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Lakeshore Foundation
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseUse online exercise platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be a member of Lakeshore Foundation
- Age 18 years or above
- Mobility limitation, problem with gait, balance and/or coordination
- Fluency in English
Key exclusion criteria (1 listed)
- No access to internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseUse online exercise platform | Behavioural | Exercise |
Primary outcome
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.
5 secondary outcomes
Change in Reasons for exercise from baseline at 8 weeks
Time frame: 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
Change in Outcome expectations for exercise from baseline at 8 weeks
Time frame: 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
Change in Health-related quality of life from baseline at 8 weeks
Time frame: Before and after 8 weeks of participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 39095876Malone LA, Mehta T, Mendonca CJ, Mohanraj S, Thirumalai M. A prospective non-randomized feasibility study of an online membership-based fitness program for promoting physical activity in people with mobility impairments. Pilot Feasibility Stud. 2024 Aug 2;10(1):104. doi: 10.1186/s40814-024-01528-x.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tapan Mehta, PhD principal investigator
University of Alabama at Birmingham
Mohanraj Thirumalai, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Physically Disabled, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Level of Physical activity from baseline at 8 weeks (time frame: Before and after 8 weeks of participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05138809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.