Active group (AG) for Venous Insufficiency of Leg

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Baylor College of Medicine, Houston, TX
Venous Insufficiency of Leg+4 More
Game-based exercise - Other
Eligibility
18+
All Sexes
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Study Summary

The present study aims to use a game-based tele-exercise program for patients using a compression garment to improve lower extremity edema. This tele-exercise gaming platform can work as an efficient exercise to improve patients' muscle strength. It also can be helpful in improving edema and venous return and can be used in addition to compression garments to increase efficacy. The sample size (n=30) is convenient and designed to explore acceptability and feasibility. Eligible participants will be screened at the Baylor college of Medicine Clinic based on the inclusion/exclusion criteria. Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. Both groups will receive a compression garment to use for 4 weeks, and in the intervention group, patients will receive a sensor and a tablet to play foot & ankle exercise games twice a day for 5 minutes. Study participation will be 4 weeks for all participants. Participants will be assessed in two visits: a baseline visit (BL) and a visit at the end of the 4 weeks (W4). The primary outcomes will be calf circumference, foot volume, and pitting edema grade. Secondary outcomes include limb strength, foot perfusion, gait assessment (gait speed, stride length, double stance, and gait steadiness), balance, and quality of life. The coordinator will monitor patients weekly to see their adherence to the compression garment and game-based exercise.

Eligible Conditions

  • Venous Insufficiency of Leg
  • Lower Extremity Swelling
  • Lower Extremity Edema

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: 4 weeks from baseline

4 weeks from baseline
Change in balance from baseline to 4 weeks
Change in calf circumference from baseline to 4 weeks
Change in foot circumference from baseline to 4 weeks
Change in foot volume from baseline to 4 weeks
Change in gait and balance from baseline to 4 weeks
Change in gastrocnemius muscle strength from baseline to 4 weeks
Change in peripheral neuropathy from baseline to 4 weeks
Change in physical activity (step count and intensity minutes) from baseline to 4 weeks
Change in pitting edema grade from baseline to 4 weeks
Change in plantar tissue oxygen saturation/consumption from baseline to 4 weeks
Patient acceptance at 4 weeks

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control group (CG)
1 of 2
Active group (AG)
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Active group (AG) · No Placebo Group · N/A

Active group (AG)
Other
Experimental Group · 1 Intervention: Game-based exercise · Intervention Types: Other
Control group (CG)NoIntervention Group · 1 Intervention: Control group (CG) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks from baseline

Trial Background

Prof. Bijan Najafi, PhD
Principal Investigator
Baylor College of Medicine
Closest Location: Baylor College of Medicine · Houston, TX
Photo of baylor college of medicine  1Photo of baylor college of medicine  2Photo of baylor college of medicine  3
2003First Recorded Clinical Trial
1 TrialsResearching Venous Insufficiency of Leg
803 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.