NCT05520008

Game-Based Foot & Ankle Exercise for Those With Lower Extremity Edema

Completed NA Last updated 18 November 2023

What this trial tests

NA trial testing Game-based exercise in Lower Extremity Swelling in 19 participants. Completed in 6 October 2023.

Timeline

3 November 2022

Primary endpoint
6 October 2023

6 October 2023

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	19
Start date	3 November 2022
Primary completion	6 October 2023
Estimated completion	6 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Game-based exercise

Conditions studied

• Lower Extremity Swelling — all drugs for Lower Extremity Swelling →
• Lower Extremity Edema — all drugs for Lower Extremity Edema →
• Venous Insufficiency of Leg — all drugs for Venous Insufficiency of Leg →

Sponsor

Baylor College of Medicine

Who can join

18 and older, any sex, with Lower Extremity Swelling or Lower Extremity Edema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.