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

NCT ID: NCT05520008

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2023-10-06

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Game-based exercise

Intervention Type: OTHER

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.

Control group (CG)

Control Group (CG). The CG (n=15) will wear a compression garment for four weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Tele-exercise

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medline Industries

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Bijan Najafi, PhD

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bijan Najafi, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

H-52182

Identifier Type: -

Identifier Source: org_study_id