NCT05138809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

September 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

September 2, 2021

Last Update Submit

May 18, 2024

Conditions

Keywords

ExercisePhysical ActivityVirtual ExerciseMobility Impairment

Outcome Measures

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.

    Before and after 8 weeks of participation

Secondary Outcomes (5)

  • Change in Reasons for exercise from baseline at 8 weeks

    Before and after 8 weeks of participation

  • Change in Self-efficacy for exercise from baseline at 8 weeks

    Before and after 8 weeks of participation

  • Change in Outcome expectations for exercise from baseline at 8 weeks

    Before and after 8 weeks of participation

  • Change in Exercise goals/plans from baseline at 8 weeks

    Before and after 8 weeks of participation

  • Change in Health-related quality of life from baseline at 8 weeks

    Before and after 8 weeks of participation

Study Arms (1)

Exercise

EXPERIMENTAL

Use online exercise platform

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Use online exercise platform

Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • No access to internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakeshore Foundation

Homewood, Alabama, 35209, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tapan Mehta, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR
  • Mohanraj Thirumalai, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Director of Research, Department of Health Services Administration

Study Record Dates

First Submitted

September 2, 2021

First Posted

December 1, 2021

Study Start

September 22, 2021

Primary Completion

May 2, 2022

Study Completion

May 2, 2022

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations