RECRUITING

The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).

Official Title

The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease

Quick Facts

Study Start:2024-09-30

Study Completion:2028-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05712395

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. history of claudication assessed by the Walking Impairment Questionnaire, 2. ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol, 3. an ABI \<= 0.90 at rest or \> 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test. 4. age \>= 60 years.	1. absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise, 2. inability to obtain an ABI measure due to non-compressible vessels (ABI \> 1.40), 3. asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test, 4. rest pain due to PAD (Fontaine stage III) 5. tissue loss due to PAD (Fontaine stage IV) 6. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation, 7. peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study, 8. exercise tolerance limited by any disease process other than PAD, 9. active cancer, 10. kidney failure defined as stage 5 chronic kidney disease, 11. a calf skin fold measurement \> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue, 12. pulse arterial oxygen saturation of the index finger \< 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and 13. failure to complete the baseline run-in phase within three weeks.

Inclusion Criteria

Exclusion Criteria

1. history of claudication assessed by the Walking Impairment Questionnaire,
2. ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,
3. an ABI \<= 0.90 at rest or \> 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.
4. age \>= 60 years.

1. absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise,
2. inability to obtain an ABI measure due to non-compressible vessels (ABI \> 1.40),
3. asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,
4. rest pain due to PAD (Fontaine stage III)
5. tissue loss due to PAD (Fontaine stage IV)
6. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
7. peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study,
8. exercise tolerance limited by any disease process other than PAD,
9. active cancer,
10. kidney failure defined as stage 5 chronic kidney disease,
11. a calf skin fold measurement \> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,
12. pulse arterial oxygen saturation of the index finger \< 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and
13. failure to complete the baseline run-in phase within three weeks.

Contacts and Locations

Study Contact

Andrew W. Gardner, Ph.D.

CONTACT

405-271-4742

andrew-gardner@ouhsc.edu

Principal Investigator

Andrew W. Gardner, Ph.D

PRINCIPAL_INVESTIGATOR

Professor, Department of Medicine, Cardiology

Study Locations (Sites)

O'Donoghue Research Building, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117

United States

Collaborators and Investigators

Sponsor: University of Oklahoma

Andrew W. Gardner, Ph.D, PRINCIPAL_INVESTIGATOR, Professor, Department of Medicine, Cardiology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30

Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-09-30

Study Completion Date2028-07-31

Terms related to this study

Additional Relevant MeSH Terms

Claudication
Peripheral Artery Disease