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
About this trial
This is an interventional treatment trial for Intermittent Claudication
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
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
NCT ID
NCT04586725
First Posted
October 7, 2020
Last Updated
July 28, 2021
Sponsor
University of Central Lancashire
Collaborators
Coventry University, University of Hull, University of Salford
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
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Effect of Encouragement on Six Minute Walk Test Performance
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