PAD, PAD - Peripheral Arterial Disease
Conditions
Brief summary
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, and decreased quality of life. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function and mobility in adults with peripheral artery disease. A total of 40 participants will be randomized to active lower-extremity heat therapy or sham therapy. Participants assigned to active therapy will complete daily 90-minute home treatment sessions using heated lower-extremity garments. Participants assigned to sham therapy will complete the same treatment schedule using a lower-temperature sham condition. The primary outcome is the change in six-minute walk distance from baseline to 12 weeks. Secondary outcomes include changes in leg strength and fatigability, Short Physical Performance Battery score, blood pressure, and patient-reported quality of life.
Detailed description
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, exercise intolerance, and decreased quality of life. Reduced physical function in individuals with peripheral artery disease can limit daily activity and contribute to progressive mobility loss. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function, lower-extremity performance, blood pressure, and quality of life in adults with peripheral artery disease. A total of 40 participants with peripheral artery disease will be enrolled and randomized to active lower-extremity heat therapy or sham therapy. Eligible participants will include men and women older than 45 years with a resting ankle-brachial index of less than 0.90 and greater than 0.40 in at least one leg. Participants will be excluded for conditions that may interfere with safe participation or outcome assessment, including critical limb ischemia, ischemic rest pain, ischemia-related non-healing wounds or tissue loss, prior amputation, major exercise-limiting comorbidity, recent lower-extremity revascularization or orthopedic surgery, use of a walking aid other than a cane, active treatment for cancer, severe chronic kidney disease, class 2 or 3 obesity, or inability to use the study treatment system as intended. Participants will complete baseline study visits that include informed consent, resting ankle-brachial index measurement, familiarization with study procedures, and baseline assessment of walking function and lower-extremity performance. Baseline outcome measures will include the six-minute walk test, assessment of calf strength and fatigability using isokinetic dynamometry, the Short Physical Performance Battery, and blood pressure measurement. After completion of baseline assessments, participants will be randomized to one of two study groups using a blocked randomization scheme stratified by sex. Participants assigned to the active therapy group will complete daily 90-minute home-based lower-extremity heat therapy sessions for 12 weeks. Participants assigned to the sham therapy group will complete the same treatment schedule using a lower-temperature sham condition designed to preserve participant blinding while minimizing the expected physiological effects of active heat therapy. Outcome assessments will be repeated at week 6 and week 12. To evaluate chronic rather than acute responses to treatment, participants will be instructed to interrupt therapy 48 hours before follow-up outcome visits. The primary outcome is the change in six-minute walk distance from baseline to 12 weeks. Secondary outcomes include changes in leg strength and fatigability, Short Physical Performance Battery score, blood pressure, and patient-reported quality of life.
Interventions
DEVICELower-Extremity Heat Therapy
Participants assigned to the active intervention will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active condition will deliver heated therapy to the lower extremities according to the study protocol.
DEVICESham Lower-Extremity Heat Therapy
Participants assigned to the sham comparator will complete home-based sham therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments as the active condition, but will use a lower-temperature condition intended to support participant blinding while minimizing the expected physiological effects of active heat therapy.
Sponsors
Aquilo Sports, LLC
Indiana University
Purdue University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women older than 50 years of age * Resting ankle-brachial index (ABI) of \<0.9 but \>0.4 in at least one leg
Exclusion criteria
* Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss * Prior amputation * Exercise-limiting comorbidity * Recent (\<3 months) lower-extremity revascularization or orthopedic surgery * Use of walking aid other than a cane * Active treatment for cancer * Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula) * Class 2 or 3 obesity (BMI ≥ 35 kg/m2) * Unable to fit into water-circulating trousers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk distance | 12 weeks | Participants will receive standardized instructions and will be asked to walk the greatest distance possible by walking back and forth along a 100-ft corridor for 6 min. The primary outcome will be a change from baseline in the 6-minute walk distance over 12 weeks in the HT-treated group as compared to the sham treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak plantar flexor and knee extensor power | 12 weeks | Torque assessments of the plantar flexors and knee extensors of the most symptomatic leg or the leg with the lowest ABI will be performed using an isokinetic dynamometer. Each subject will be asked to perform 3 maximal contractions at angular velocities of 0, 1.57, 3.14, 4.71, and 6.28 rad/sec, with 2 min of rest between each set. Peak power will be calculated by multiplying the peak torque observed at each velocity by that velocity. A parabolic function will be used to determine the subject's maximal plantar flexor velocity (Vmax) and maximal power (P max). The change in peak power from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group. |
| Plantar flexor and knee extensor resistance to fatigue | 12 weeks | Participants will perform 50 consecutive maximal contractions of the plantar flexor and knee extensor muscles at an angular velocity of 3.14 rad/sec to determine their resistance to fatigue. The fatigue index will be defined as a % decrease in power from first 1/3 to last 1/3 of the test) during repeated contractions. The change in fatigue resistance from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group. |
| Short Physical Performance Battery (SPPB) score | 12 weeks | The SPPB combines data from the usual paced 4-m walking velocity, time to rise from a seated position 5 times, and standing balance. The timed results of the subtests will be converted to an ordinal scale ranging from 0 (worst performance) to 12 (best performance) (1). The change in the SPPB score from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group. |
| Walking Impairment Questionnaire (WIQ) | 12 weeks | This disease-specific questionnaire assesses the ability of patients with PAD to walk defined distances and speeds and to climb stairs, with scores ranging from 0 to 100. The change in the WIQ score from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group. |
Countries
United States
Contacts
CONTACTRaghu Motaganahalli, MD
PRINCIPAL_INVESTIGATORRaghu Motaganahalli, MD
Indiana University
Outcome results
None listed