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The Effects of Claudication Severity on Functional Outcomes

NCT04370327 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-11-03

No results posted yet for this study

Summary

Peripheral artery disease (PAD) affects over 236 million people globally. A classic symptom of PAD is intermittent claudication (IC) which is associated with reductions in physical function. The evidence is irrefutable that supervised exercise programmes (SEP) improve pain free and maximal waking distance. However, adherence rates are poor with exercise-related pain cited as contributable factor. Exercise at mild claudication or pain- free exercise improves walking ability, however current guidelines recommend exercise should be performed to near maximal claudication to improve walking ability. Conflicting evidence exists and there is a lack of evidence that has directly compared the relative effects of exercise prescribed at different levels of claudication. Therefore, the primary objective is to directly compare the effects of exercise prescribed at different levels of claudication pain on functional outcomes

Conditions

  • Intermittent Claudication

Interventions

OTHER

Pain Free Exercise (PF)

Patients will exercise until the onset on claudication (1 on the rating scale)

OTHER

Moderate Claudication Pain Exercise (MOD-P)

Patients will exercise until they experience moderate claudication pain (2 on the rating scale)

OTHER

Maximal Claudication Pain Exercise (MAX-P)

Patients will exercise until they experience maximal claudication pain (4 on the rating scale)

Sponsors & Collaborators

  • University of Central Lancashire

    lead OTHER

Principal Investigators

  • Stefan Birkett, PHD · University of Central Lancashire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • United Kingdom

Study Locations

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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 NCT04370327 on ClinicalTrials.gov