Lower Extremity SwellingNCT05520008
Game-Based Foot & Ankle Exercise for Those With Lower Extremity Edema
A study testing Game-based exercise in people with Lower Extremity Swelling and Lower Extremity Edema, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Swelling, Lower Extremity Edema, Venous Insufficiency of Leg
- What is being tested?
- Game-based exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 6 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18+ years old) who have lower extremity edema
- Willing to attend clinic for assessments
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Game-based exercise
- Keywords
- Compression Garment, Game-based Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-based exerciseOther
Also called Tele-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.
| Study group | Role | What they receive |
|---|---|---|
| Active group (AG) | Experimental | 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. Receives: Other: Game-based exercise |
| Control group (CG) | No intervention | Control Group (CG). The CG (n=15) will wear a compression garment for four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in calf circumference from baseline to 4 weeks
Calf circumference will be assessed with a soft measuring tape for each leg
Measured: 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
Measured: 4 weeks from baseline
Change in foot volume from baseline to 4 weeks
Foot volume will be assessed with a standard foot volumeter
Measured: 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
Measured: 4 weeks from baseline
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 4 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start3 Nov 2022
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity SwellingStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medline Industries
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
- Investigators
- Bijan Najafi, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520008
- Sponsor's protocol ID
- H-52182
- Status last verified
- Nov 2023
- First submitted
- 26 Aug 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Game-based Foot & Ankle Exercise Program to Increase Efficacy Of Compression Garments At Managing Edema
- ClinicalTrials.gov ID
- NCT05520008
- Acronym / sponsor ID
- H-52182
- Keywords
- Compression Garment, Game-based Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Medline Industries
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active group (AG) | Experimental | Other: Game-based exerciseActive 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. |
| Control group (CG) | No intervention | –Control Group (CG). The CG (n=15) will wear a compression garment for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18+ years old) who have lower extremity edema
- Willing to attend clinic for assessments
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game-based exerciseAlso: Tele-exercisePatients 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 | Active group (AG) |
Primary outcome
Change in calf circumference from baseline to 4 weeks
Time frame: 4 weeks from baseline
Calf circumference will be assessed with a soft measuring tape for each leg
Change in foot circumference from baseline to 4 weeks
Time frame: 4 weeks from baseline
Foot circumference will be assessed with a soft measuring tape for each leg
Change in foot volume from baseline to 4 weeks
Time frame: 4 weeks from baseline
Foot volume will be assessed with a standard foot volumeter
Change in pitting edema grade from baseline to 4 weeks
Time frame: 4 weeks from baseline
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 secondary outcomes
Change in gastrocnemius muscle strength from baseline to 4 weeks
Time frame: 4 weeks from baseline
Change in gait and balance from baseline to 4 weeks
Time frame: 4 weeks from baseline
Change in balance from baseline to 4 weeks
Time frame: 4 weeks from baseline
Change in plantar tissue oxygen saturation/consumption from baseline to 4 weeks
Time frame: 4 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bijan Najafi, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-based exercise in people with Lower Extremity Swelling and Lower Extremity Edema, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in calf circumference from baseline to 4 weeks (time frame: 4 weeks from baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.