Home-Based Lower-Extremity Heat Therapy for Walking Function in Peripheral Artery Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorAquilo Sports, LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lower-Extremity Heat Therapy
DeviceParticipants 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.
Sham Lower-Extremity Heat Therapy
DeviceParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active Lower-Extremity Heat TherapyExperimental treatment 1 intervention
Group B: Sham Lower-Extremity Heat TherapySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
6-minute walk distance
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.
Time frame
12 weeksSecondary outcomes
1
Peak plantar flexor and knee extensor power
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.
Time frame
12 weeks2
Plantar flexor and knee extensor resistance to fatigue
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.
Time frame
12 weeks3
Short Physical Performance Battery (SPPB) score
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.
Time frame
12 weeks4
Walking Impairment Questionnaire (WIQ)
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.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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