Clinical trial NCT05520008: Game-Based Foot & Ankle Exercise for Those With Lower Extremity Edema
Official title: A Game-based Foot & Ankle Exercise Program to Increase Efficacy Of Compression Garments At Managing Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Swelling
Lower Extremity Edema
Venous Insufficiency of Leg
Keywords: Compression Garment
Game-based Exercise
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Medline Industries
First posted: 2022-08-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with a ratio of 1:1 into two groups. Both groups will be given a compression garment (CompreCares, Medline, IL, USA) to wear for the 4 weeks of the study. The Active group (AG) will also be allocated a tablet and foot sensor so that they can play game-based foot \& ankle exercises during the same time period. The other group (Control group, CG) will only use the compression garment.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Lower extremity edema (LE) is an accumulation of interstitial fluid volume in the legs and feet and commonly occurs in patients with diabetes, hypertension, kidney disease, heart failure, cirrhosis, cancer, and obesity. LE can also result from deep vein thrombosis (DVT) in the lower leg. Compression socks or garments are often used to decrease this edema. Despite the efficacy of this treatment, there are some limitations including low patient compliance and contraindication of high compression levels for patients with high grades of peripheral arterial disease. Given that it is has previously been shown that exercise can be a positive way to reduce LE, the present study aims to use a game-based exercise program to help increase patient's movement and thus improve efficacy and adherence to the compression garments/socks.

The investigators will recruit 30 participants and randomly divide them into two groups: Active Group (AG) and Control Group (CG). Both groups will receive a compression garment (CompreCares) developed by Medline Incorporated(Inc). (IL, USA). The AG will receive a tablet and foot sensor (TEXASSENSE INC, USA), and will be instructed to play with it daily for 5 minutes over the period of 4 weeks.

During the two study visits (BL and W4), the investigators will assess the following outcomes: calf muscle activation (assessed by surface electromyography \[sEMG\]), foot perfusion (SNAPSHOT NIR, Kent Imaging System), calf and foot circumference, ankle-brachial index (ABI), pitting edema test, foot volume, gait, balance, and peripheral neuropathy (DPNCheck, Neurometrix Inc., Woburn, Massachusetts, USA).

Acceptability and patient reported outcomes will be assessed via validated questionnaires collected at each study visit.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18+ years old) who have lower extremity edema
* Willing to attend clinic for assessments

Exclusion Criteria:

* Severe cognitive decline that reduces their ability to use tele-foot exercise device
* Major visual problems that reduces their ability to use tele-foot exercise device
* Inability to walk independently for a distance of 10 meters
* Major foot problems such as active lower extremity wounds
* Major foot deformity (e.g., Charcot Foot)
* Previous major amputations, and claudication
* Decompensated or advanced heart failure New York Heart Association (NYHA) Functional Class(FC) III-IV
* Significant heart disease

Primary outcomes:
measure: Change in calf circumference from baseline to 4 weeks
timeFrame: 4 weeks from baseline
measure: Change in foot circumference from baseline to 4 weeks
timeFrame: 4 weeks from baseline
measure: Change in foot volume from baseline to 4 weeks
timeFrame: 4 weeks from baseline
measure: Change in pitting edema grade from baseline to 4 weeks
timeFrame: 4 weeks from baseline
Secondary outcomes:
measure: Change in gastrocnemius muscle strength from baseline to 4 weeks
timeFrame: 4 weeks from baseline
measure: Change in gait and balance from baseline to 4 weeks
timeFrame: 4 weeks from baseline
measure: Change in balance from baseline to 4 weeks
timeFrame: 4 weeks from baseline
measure: Change in plantar tissue oxygen saturation/consumption from baseline to 4 weeks
timeFrame: 4 weeks from baseline
Other outcomes:
measure: Change in peripheral neuropathy from baseline to 4 weeks
timeFrame: 4 weeks from baseline
measure: Patient acceptance at 4 weeks
timeFrame: 4 weeks from baseline
measure: Change in physical activity (step count and intensity minutes) from baseline to 4 weeks
timeFrame: 4 weeks from baseline
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Bijan Najafi, PhD
role: PRINCIPAL_INVESTIGATOR
References: