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Effect of Encouragement on Six Minute Walk Test Performance

Primary Purpose

Intermittent Claudication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Encouragement a one minute intervals
Encouragement a two minute intervals
Sponsored by
University of Central Lancashire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. >18 years old
  2. Resting ankle brachial pressure index (ABPI) <0.9 or a reduction of ≥ 20 mmHg following exercise testing (per site protocol)
  3. Able to walk unaided
  4. English speaking and able to follow exercise instructions
  5. Able to provide informed consent

Exclusion Criteria:

  1. Those who have critical limb threatening ischaemia (rest pain and/or tissue loss)
  2. Unable to provide consent
  3. Those presenting with any significant comorbidities or contraindications to exercise testing or training in accordance to the American College of Sports Medicine
  4. Uncontrolled or symptom limiting coronary heart or pulmonary disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Encouragement every minute

    Encouragement every two minutes

    Arm Description

    Patients will be randomised to six tests at one week apart

    Patients will be randomised to six tests at one week apart

    Outcomes

    Primary Outcome Measures

    Maximal walking distance (MWD)
    Metres walked during the tests

    Secondary Outcome Measures

    Learning effect metres walked
    To see if a learning effect exists between tests

    Full Information

    First Posted
    October 7, 2020
    Last Updated
    July 28, 2021
    Sponsor
    University of Central Lancashire
    Collaborators
    Coventry University, University of Hull, University of Salford
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04586725
    Brief Title
    Effect of Encouragement on Six Minute Walk Test Performance
    Official Title
    The Effect of Encouragement on Six Minute Walk Test Performance in Patients With Intermittent Claudication
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Central Lancashire
    Collaborators
    Coventry University, University of Hull, University of Salford

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed Description
    Peripheral artery disease (PAD) is characterised by atherosclerotic lesions of the arteries in the lower limbs, resulting in a reduction of blow flow (Hiatt, 2001). Globally, it is estimated that 236 million people are living with PAD, with the number of cases increasing by 24% from 2000 to 2010. A classic symptom of PAD is intermittent claudication (IC), characterised by ischemic muscle pain precipitated by exertion and relieved by rest. IC is associated with various comorbidities such as diabetes mellitus, hypertension and dyslipidaemia as well as reductions in physical function, quality of life, and balance. National and international guidelines recommend supervised exercise therapy as first line treatment for patients with IC. To assess IC impairment in response to an exercise intervention, maximal walking capacity is typically the primary outcome in randomised controlled trials (RCT's). This involves a patient walking for as long as possible until ischemic leg symptoms, fatigue or other symptoms prevent them from continuing. This is assessed by a number of exercise testing protocols including the six-minute walk test (6MWT). The American Thoracic Society provide guidelines for performing a standardised 6MWT including verbal phrases that are conducted every minute. Conversely, Montgomery and Gardner suggest encouragement every two minutes. Encouragement has been shown to significantly affect 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 investigated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intermittent Claudication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Masking Description
    Participants will be blinded to the level of encouragement they will receive during the tests
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Encouragement every minute
    Arm Type
    Active Comparator
    Arm Description
    Patients will be randomised to six tests at one week apart
    Arm Title
    Encouragement every two minutes
    Arm Type
    Active Comparator
    Arm Description
    Patients will be randomised to six tests at one week apart
    Intervention Type
    Other
    Intervention Name(s)
    Encouragement a one minute intervals
    Intervention Description
    Patients will perform the six exercise tests with encouragement at one minute intervals
    Intervention Type
    Other
    Intervention Name(s)
    Encouragement a two minute intervals
    Intervention Description
    Patients will perform the six exercise tests with encouragement at two minute intervals
    Primary Outcome Measure Information:
    Title
    Maximal walking distance (MWD)
    Description
    Metres walked during the tests
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Learning effect metres walked
    Description
    To see if a learning effect exists between tests
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >18 years old Resting ankle brachial pressure index (ABPI) <0.9 or a reduction of ≥ 20 mmHg following exercise testing (per site protocol) Able to walk unaided English speaking and able to follow exercise instructions Able to provide informed consent Exclusion Criteria: Those who have critical limb threatening ischaemia (rest pain and/or tissue loss) Unable to provide consent Those presenting with any significant comorbidities or contraindications to exercise testing or training in accordance to the American College of Sports Medicine Uncontrolled or symptom limiting coronary heart or pulmonary disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stefan Birkett, PhD
    Phone
    01772 893325
    Email
    SBirkett4@uclan.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Encouragement on Six Minute Walk Test Performance

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