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Near-Infrared Spectroscopy-Guided Exercise Training in Peripheral Arterial Disease

NCT03478085 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-03-27

No results posted yet for this study

Summary

Background: Patients suffering with atherosclerotic peripheral arterial disease (PAD) have limited therapeutic options to improve claudication. Supervised exercise programs are generally effective in improving leg pain from walking, but are poorly adhered to because of patient discomfort. The benefit of exercise training programs is thought to be mediated in part through repeated ischemic stimuli that activate endogenous regenerative mechanisms. In preliminary studies, exercise-induced tissue desaturation by near infrared spectroscopy (NIRS) precedes the onset of leg pain. This proposal aims to explore a novel strategy of exercise training in PAD based on measured tissue hypoxia rather than pain symptoms using NIRS to non-invasively characterize muscle oxygen tension.

Methods: In subjects with symptomatic peripheral arterial disease, the efficacy of a novel NIRS-based strategy of thrice-weekly exercise training will be assessed. Enrolled subjects will be randomized to NIRS-based training, traditional claudication-based training, or self-directed walking. The hypotheses tested include: 1) NIRS-directed exercise improves claudication to a similar degree as symptom-directed exercise training and 2) is superior to self-directed walking. In the symptom-based group, physical effort will be dictated by claudication symptoms, whereas in the hypoxia-based training program, physical effort is dictated by NIRS measure of calf oxygen tension. Efficacy in the training programs will be evaluated by total walking time on a standard graded treadmill test after 12 weeks. Other measures will be claudication onset time, subjective and objective measures of physical activity, changes in vascular function. In addition, the hypothesis that hypoxia-directed training will result in increased ischemic signaling and increased progenitor cell mobilization to a degree similar as in claudication-based training will be tested.

Conclusions: These experiments will test whether a training strategy based on tissue hypoxia (measured by NIRS) is as effective as and more tolerable than traditional symptom-based training programs in PAD. In addition, these experiments will characterize mechanistic responses to hypoxia that may account for clinical improvements that exercise training affords.

Conditions

  • Peripheral Arterial Disease

Interventions

OTHER

Oxygen guided exercise therapy

Subjects exercise to a certain intensity based on 15% muscle oxygen desaturation.

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-01
Primary Completion
2016-05-31
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478085 on ClinicalTrials.gov