- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04586725
Effect of Encouragement on Six Minute Walk Test Performance
The Effect of Encouragement on Six Minute Walk Test Performance in Patients With Intermittent Claudication
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefan Birkett, PhD
- Phone Number: 01772 893325
- Email: SBirkett4@uclan.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Encouragement every minute
Patients will be randomised to six tests at one week apart
|
Patients will perform the six exercise tests with encouragement at one minute intervals
Patients will perform the six exercise tests with encouragement at two minute intervals
|
Active Comparator: Encouragement every two minutes
Patients will be randomised to six tests at one week apart
|
Patients will perform the six exercise tests with encouragement at one minute intervals
Patients will perform the six exercise tests with encouragement at two minute intervals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal walking distance (MWD)
Time Frame: 6 weeks
|
Metres walked during the tests
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Learning effect metres walked
Time Frame: 6 weeks
|
To see if a learning effect exists between tests
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCentalLancashire2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intermittent Claudication
-
Mid and South Essex NHS Foundation TrustRecruitingPeripheral Arterial Disease | Claudication, IntermittentUnited Kingdom
-
Louis MessinaBioMarin PharmaceuticalRecruitingPeripheral Vascular Diseases | Peripheral Artery Disease | Claudication, IntermittentUnited States
-
University Hospital, AngersCompletedPeripheral Artery Disease | Claudication, IntermittentFrance
-
Palo Alto Veterans Institute for ResearchSociety for Vascular SurgeryWithdrawnPeripheral Artery Disease | Claudication, Intermittent
-
Biotronik AGCompletedSevere Intermittent Claudication | Patients With Symptomatic Critical Limb IschemiaGermany
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity Hospital, Angers; Imperial College London; Sheffield Hallam UniversityCompletedIntermittent ClaudicationUnited Kingdom
-
University Hospital, EssenStraub Medical AGUnknownPeripheral Arterial Disease | Claudication, IntermittentGermany
-
University Hospital, EssenUnknownPeripheral Arterial Disease | Claudication, IntermittentGermany
-
Paradigm SpineCompletedIntermittent Neurogenic Claudication (INC) as a Result of Spinal StenosisNetherlands
-
Imperial College LondonTerminatedStandardised Claudication Treadmill TestUnited Kingdom
Clinical Trials on Encouragement a one minute intervals
-
Texas Woman's UniversityNot yet recruitingDiabetes ComplicationsUnited States
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)RecruitingSedentary Behavior | Sedentary TimeUnited States
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompleted
-
Vanderbilt University Medical CenterCompleted
-
Aline ReinmannCompleted
-
Nottingham University Hospitals NHS TrustCompletedPhysical Activity | Moving Medicine | Acute Medical UnitUnited Kingdom
-
University College, LondonMedical Research CouncilCompletedPHYSICAL FITNESSUnited Kingdom
-
University of AarhusThe Danish Rheumatism AssociationActive, not recruitingScleroderma, Systemic | Pulmonary Arterial Hypertension | Lung Diseases, Interstitial | AcroosteolysisDenmark
-
University of North Carolina, GreensboroRecruitingBehavioral Symptoms | Depressive Symptoms | Anxiety Disorders and Symptoms | Ethnic-Racial SocializationUnited States