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Effect of Encouragement on Six Minute Walk Test Performance

NCT04586725 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2021-08-04

No results posted yet for this study

Summary

Peripheral artery disease (PAD) is characterised by a build up of fatty plaque in the arteries in the lower limbs, resulting in a reduction of blow flow to the muscles. Globally, it is estimated that 236 million people are living with PAD. A classic symptom of PAD is intermittent claudication (IC) which is characterised by muscle cramps in the lower limbs, typically brought on by exercise and relieved at rest. Exercise is recommended at first line treatment for IC. However to assess IC symptoms in response to an exercise study, maximal walking capacity (the furthest they can walk before it becomes too painful to walk) is typically the main measure. A patients walking capacity is assessed by a number of exercise testing protocols including the six-minute walk test (6MWT), where patients walk for six minutes with the aim to walk as far as they can in the time allotted. Patient encouragement has been shown to improve walking performance by as much as 30 meters in heart failure and respiratory disease populations. However the effect of encouragement on walking performance in people with IC is yet to be studied.

Conditions

  • Intermittent Claudication

Interventions

OTHER

Encouragement a one minute intervals

Patients will perform the six exercise tests with encouragement at one minute intervals

OTHER

Encouragement a two minute intervals

Patients will perform the six exercise tests with encouragement at two minute intervals

Sponsors & Collaborators

  • Coventry University

    collaborator OTHER

  • University of Hull

    collaborator OTHER

  • University of Salford

    collaborator OTHER

  • University of Central Lancashire

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-12-01
Completion
2024-01-01

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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 NCT04586725 on ClinicalTrials.gov