Peripheral Artery Disease
Conditions
Keywords
Peripheral artery disease
Brief summary
Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis that blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. The risk of mortality of Veterans with PAD is substantial; nearly 30% of Veterans with PAD died within 3.8 years of diagnosis. This project aims to establish the feasibility and acceptability of specially designed assistive shoes in patients with PAD and to determine if there are any potential benefits of using these shoes over standard shoes. These assistive shoes may enable patients to carry out desired activities of daily living with less pain and more physical activity. Increasing physical activity will decrease morbidity and mortality. If proven beneficial, the findings will lead to a novel and conservative rehabilitation protocol that directly benefits Veterans nationwide.
Detailed description
The long-term goal of this project is to improve mobility, functional independence, and quality of life in patients with peripheral artery disease (PAD) by using specially designed assistive shoes. PAD is a manifestation of systemic atherosclerosis, producing blockages in the leg arteries, resulting in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed nationwide in the VA. Walking-induced muscle pain, known as intermittent claudication, is the most common PAD symptom. Claudicating patients with PAD walk slower, have reduced quality of life and lose independence in performing activities of daily living. The investigators have identified consistent deficits of the ankle plantarflexors to effectively push-off during walking. Currently, there is a critical treatment gap for patients whose disease presentation does not warrant an operative approach, but who desire to restore their functional independence and walking ability. Specially designed assistive shoes (carbon fiber: CF; spring-loaded: SL) with specific mechanical properties to absorb and release energy, have been shown to promote push-off efficiency in walkers and runners. These shoes may lead to improved push-off in populations with reduced ankle push-off capacity, but this has not been tested yet. This work proposes to evaluate patient preferences in terms of using assistive shoes and whether these shoes improve walking performance in claudicating patients with PAD. The investigators hypothesize that using assistive shoes (either CF or SL, based on their preference) for three months will lead to improved walking performance in patients with PAD. The investigators also hypothesize that the subject-reported preference of assistive shoes (CF versus SL) will be positive based on comfort, fatigue, ease of walking, and feasibility at the baseline session. Two hypotheses will be tested by the following three specific aims: Aim 1: Determine the subject-reported preference of assistive shoes at the Baseline visit. Aim 2: Determine the progressive improvements in physical activity, quality of life, and walking distance after a three-month assistive shoe intervention. Twenty patients with PAD will be recruited. Aim 1 will primarily focus on qualitative measurements of subjects' reported preferences to identify which assistive shoes are feasible for patients with PAD to use during the three months of intervention. Visual-analog scales, rate of perceived exertion, and interviews will be used to assess comfort, fatigue, intensity, and feasibility after each shoe condition of Aim 1. Patients will wear the preferred assistive shoes of their choice for regular daily use for three months as a conservative intervention. Physical activity, quality of life, and walking distances will be assessed prior to the start of the intervention and after three months of intervention. Overall, the aims will demonstrate the feasibility and acceptability of assistive shoes in patients with PAD. Results will support a full clinical trial and guide necessary intervention length and potential rehabilitation recommendations.
Interventions
Assistive shoes include carbon-fiber and spring loaded shoes.
Sponsors
Study design
Intervention model description
Ten patients will wear assistive shoes for 3 months.
Eligibility
Inclusion criteria
At entry into the study, all patients must: * be able to give written, informed consent * demonstrate positive history of chronic claudication * have an ankle brachial index \< 0.90 at rest * have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks
Exclusion criteria
Any potential subjects will be excluded if they have: * rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV) * acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma * walking capacity significantly limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Walking Distance After Three-months Intervention | Baseline and after three-months intervention | In this single-arm study, investigators assessed absolute claudication walking distance using the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included. |
| Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants | Baseline | At the baseline session, participants will be asked to rate the comfort of each assistive shoe on a scale from 0 to 10, where 0 indicates Low comfort and 10 indicates High comfort. During this session, all participants will walk in three different shoes and provide a comfort rating for each. Based on these ratings, one shoe will be selected for the participant to use over the following three months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Vertical Ground Reaction Force After Three-months Intervention | Baseline and after three-months intervention | In this single-arm study, investigators assessed vertical ground reaction force from a pressure-instrumented treadmill during the Gardner treadmill test while walking in their normal shoes. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included. |
| Changes in Muscle Oxygenation After Three-months Intervention | Baseline and after three-months intervention | In this single-arm study, investigators will assess minimum muscle oxygenation during the Gardner treadmill test while wearing their normal shoes. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included. |
| Changes in Physical Activity After Three-months Intervention | Baseline and after three-months intervention | In this single-arm study, investigators calculated the average number of steps per day as a measure of physical activity using an ActiGraph accelerometer worn by participants. All participants underwent a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on their personal preference. No control group was included. Participants wore the accelerometer for 7 days before the intervention and again for 7 days after completing the three-month intervention period. |
| Changes in Rate of Perceived Exertion Score After Three-months Intervention | Baseline and after three-months intervention | In this single-arm study, investigators assessed the rate of perceived exertion (RPE) immediately after the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included. The RPE score ranged from 6 to 20, where 6 indicated no exertion at all and 20 indicated maximal exertion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Progressive Improvement in Walking Performance A total of ten patients with peripheral artery disease will be enrolled for this arm and wear the assistive tennis shoes for three-months as an intervention.
Assistive tennis shoes: Assistive shoes include carbon-fiber and spring loaded shoes. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Progressive Improvement in Walking Performance |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 70.3 years STANDARD_DEVIATION 8.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Progressive improvement in walking performance Female | 0 Participants |
| Sex: Female, Male Progressive improvement in walking performance Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Changes in Walking Distance After Three-months Intervention
In this single-arm study, investigators assessed absolute claudication walking distance using the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Time frame: Baseline and after three-months intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Improvement in Walking Performance | Changes in Walking Distance After Three-months Intervention | Baseline | 289.68 meters | Standard Deviation 196.11 |
| Progressive Improvement in Walking Performance | Changes in Walking Distance After Three-months Intervention | After Three months | 262.95 meters | Standard Deviation 165.97 |
Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants
At the baseline session, participants will be asked to rate the comfort of each assistive shoe on a scale from 0 to 10, where 0 indicates Low comfort and 10 indicates High comfort. During this session, all participants will walk in three different shoes and provide a comfort rating for each. Based on these ratings, one shoe will be selected for the participant to use over the following three months.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Improvement in Walking Performance | Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants | standard shoe | 5.5 units on a scale | Standard Deviation 1.08 |
| Progressive Improvement in Walking Performance | Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants | carbon fiber | 5.9 units on a scale | Standard Deviation 2.3 |
| Progressive Improvement in Walking Performance | Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants | spring loaded | 6.6 units on a scale | Standard Deviation 2.06 |
Changes in Muscle Oxygenation After Three-months Intervention
In this single-arm study, investigators will assess minimum muscle oxygenation during the Gardner treadmill test while wearing their normal shoes. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Time frame: Baseline and after three-months intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Improvement in Walking Performance | Changes in Muscle Oxygenation After Three-months Intervention | Baseline | 36.82 Muscle oxygen saturation percentage | Standard Deviation 15.92 |
| Progressive Improvement in Walking Performance | Changes in Muscle Oxygenation After Three-months Intervention | After three months | 40.02 Muscle oxygen saturation percentage | Standard Deviation 12.3 |
Changes in Physical Activity After Three-months Intervention
In this single-arm study, investigators calculated the average number of steps per day as a measure of physical activity using an ActiGraph accelerometer worn by participants. All participants underwent a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on their personal preference. No control group was included. Participants wore the accelerometer for 7 days before the intervention and again for 7 days after completing the three-month intervention period.
Time frame: Baseline and after three-months intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Improvement in Walking Performance | Changes in Physical Activity After Three-months Intervention | Baseline | 4099.102 steps/day | Standard Deviation 4035.33 |
| Progressive Improvement in Walking Performance | Changes in Physical Activity After Three-months Intervention | After three months intervention | 4740.85 steps/day | Standard Deviation 4913.19 |
Changes in Rate of Perceived Exertion Score After Three-months Intervention
In this single-arm study, investigators assessed the rate of perceived exertion (RPE) immediately after the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included. The RPE score ranged from 6 to 20, where 6 indicated no exertion at all and 20 indicated maximal exertion.
Time frame: Baseline and after three-months intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Improvement in Walking Performance | Changes in Rate of Perceived Exertion Score After Three-months Intervention | Baseline | 12.6 score on a scale | Standard Deviation 2.7 |
| Progressive Improvement in Walking Performance | Changes in Rate of Perceived Exertion Score After Three-months Intervention | After three months | 13.25 score on a scale | Standard Deviation 2.3 |
Changes in Vertical Ground Reaction Force After Three-months Intervention
In this single-arm study, investigators assessed vertical ground reaction force from a pressure-instrumented treadmill during the Gardner treadmill test while walking in their normal shoes. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Time frame: Baseline and after three-months intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Improvement in Walking Performance | Changes in Vertical Ground Reaction Force After Three-months Intervention | Baseline | 769.34 Newton | Standard Deviation 150.09 |
| Progressive Improvement in Walking Performance | Changes in Vertical Ground Reaction Force After Three-months Intervention | after three-months intervention | 845.38 Newton | Standard Deviation 118.24 |