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

A Game-based Foot & Ankle Exercise Program to Increase Efficacy Of Compression Garments At Managing Edema

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.

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency of Leg; Lower Extremity Swelling; Lower Extremity Edema
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active group (AG); Active group (AG). The AG (n=15) will play game-based foot and ankle exercises via a mobile application on a tablet. They will be asked to wear a foot sensor that is connected to the tablet during the exercise. They will be asked to play the game for 5-minutes, daily. They will do this in conjunction with wearing a compression garment for a period of 4 weeks.	Other: Game-based exercise; Patients in the active group will put on a sensor connected to a tablet to play a game-based foot/ankle exercise twice a day for 5 minutes for four weeks.; Other Names: Tele-exercise
No Intervention: Control group (CG); Control Group (CG). The CG (n=15) will wear a compression garment for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in calf circumference from baseline to 4 weeks	Calf circumference will be assessed with a soft measuring tape for each leg	4 weeks from baseline
Change in foot circumference from baseline to 4 weeks	Foot circumference will be assessed with a soft measuring tape for each leg	4 weeks from baseline
Change in foot volume from baseline to 4 weeks	Foot volume will be assessed with a standard foot volumeter	4 weeks from baseline
Change in pitting edema grade from baseline to 4 weeks	Coordinators will press on the affected area in the lower extremities and measure depth of indention. They will record the length of skin rebound time and grade the edema based on validated scales	4 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gastrocnemius muscle strength from baseline to 4 weeks	Lower extremity strength will be assessed with an ankle dynamometer and surface electromyography (Delsys Trigno Wireless EMG System, MA, US).	4 weeks from baseline
Change in gait and balance from baseline to 4 weeks	Gait speed will be measured with standard walking tests and wearable sensors (Legsys).	4 weeks from baseline
Change in balance from baseline to 4 weeks	Static balance will be measured with standard balance tests and wearable sensors (Balansens).	4 weeks from baseline
Change in plantar tissue oxygen saturation/consumption from baseline to 4 weeks	Percentage of tissue oxygen saturation (SatO2) and hemoglobin values will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 and level in superficial tissue. The area that will be captured is the metatarsus area	4 weeks from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peripheral neuropathy from baseline to 4 weeks	Peripheral neuropathy will be assessed using DPNCheck (Neurometrix, Woburn, MA, USA). This is a noninvasive device which will measure conduction velocity and amplitude.	4 weeks from baseline
Patient acceptance at 4 weeks	Participant acceptance of the tele-exergaming program will be assessed at the end of their participation using a validated technology acceptance model (TAM) questionnaire	4 weeks from baseline
Change in physical activity (step count and intensity minutes) from baseline to 4 weeks	Physical activity metrics, such as step count and intensity minutes, will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US)	4 weeks from baseline

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Medline Industries
• Investigators: Principal Investigator: Bijan Najafi, PhD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Compression Garment; Game-based Exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Edema; Venous Insufficiency
• Other Study ID Numbers: H-52182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No