The Effects of Claudication Severity on Functional Outcomes
Primary Purpose
Intermittent Claudication
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pain Free Exercise (PF)
Moderate Claudication Pain Exercise (MOD-P)
Maximal Claudication Pain Exercise (MAX-P)
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) <90 mmHg
- 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 undergoing active cancer treatment
- Those presenting with any significant comorbidities or contraindications to exercise testing or training in accordance to the American College of Sports Medicine
- Unstable/uncontrolled coronary heart disease
Sites / Locations
- School of Sport and and Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Pain Free Exercise (PF)
Moderate Claudication Pain Exercise (MOD-P)
Maximal Claudication Pain Exercise (MAX-P)
Arm Description
Patients will be randomised to twice weekly for 24 weeks of pain free exercise in a supervised exercise programme
Patients will be randomised to twice weekly for 24 weeks of moderate claudication pain exercise in a supervised exercise programme
Patients will be randomised to twice weekly for 24 weeks of maximal claudication pain exercise in a supervised exercise programme
Outcomes
Primary Outcome Measures
Change in Maximal Walking Distance (MWD)
Metres walked until maximal claudication pain
Secondary Outcome Measures
Change in Pain Free Walking Distance (PFWD)
Metres walked pain free
Adherence
Recording the number of training sessions attended and successfully completed
Change in Quality of Life
King College 24-item Vascular Quality of life and walking impairment questionnaire
Full Information
NCT ID
NCT04370327
First Posted
April 23, 2020
Last Updated
November 1, 2022
Sponsor
University of Central Lancashire
1. Study Identification
Unique Protocol Identification Number
NCT04370327
Brief Title
The Effects of Claudication Severity on Functional Outcomes
Official Title
The Effects of Claudication Severity on Functional Outcomes in Patients With Intermittent Claudication
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Lancashire
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) 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
Detailed Description
Peripheral artery disease (PAD) is a progressive disease and is characterised by atherosclerotic occlusion of the arteries in the lower limbs, resulting in a reduction of blow flow. Globally, it is estimated that 236 million people are living with PAD, with the number of cases increasing by 24% from 2000 to 2010 (Song et al., 2019). A classic symptom of PAD is intermittent claudication (IC), which is 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 exercise therapy as first line treatment for patients with IC, advocating two hours per week of a supervised exercise over a three-month period, with patients being encouraged to exercise to the point of maximal pain. Exercise therapy is also a cost-effective option, as a three month programme costs less than a tenth of the cost of angioplasty.
However, despite the plethora of evidence demonstrating the benefits of SEP, less than half of vascular units in the United Kingdom (UK) have access one and patient uptake rates low. A lack of motivation has been shown as one of the primary reasons for poor adherence with claudication pain being suggested as a contributable factor. Indeed, exercise-induced pain has been shown as a major barrier to physical activity in this population and the level of pain prescribed during SEP influences completion rates. When exercise is prescribed at higher levels of pain, completion rates are lower. However, current evidence and guidelines advocate exercising to the point of near maximal pain, despite evidence to the contrary, suggesting that mild- or pain-free exercise improves walking ability. As such, it remains unclear which level of claudication is optimal for improving functional outcomes in patients with IC which can affect patient adherence, clinical practice and exercise prescription. The lack of adequately powered, randomised clinical trials investigating the effects of exercise prescribed at differing levels of claudication pain has also been highlighted in a recent scientific statement from the American Heart Association
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain Free Exercise (PF)
Arm Type
Active Comparator
Arm Description
Patients will be randomised to twice weekly for 24 weeks of pain free exercise in a supervised exercise programme
Arm Title
Moderate Claudication Pain Exercise (MOD-P)
Arm Type
Active Comparator
Arm Description
Patients will be randomised to twice weekly for 24 weeks of moderate claudication pain exercise in a supervised exercise programme
Arm Title
Maximal Claudication Pain Exercise (MAX-P)
Arm Type
Active Comparator
Arm Description
Patients will be randomised to twice weekly for 24 weeks of maximal claudication pain exercise in a supervised exercise programme
Intervention Type
Other
Intervention Name(s)
Pain Free Exercise (PF)
Intervention Description
Patients will exercise until the onset on claudication (1 on the rating scale)
Intervention Type
Other
Intervention Name(s)
Moderate Claudication Pain Exercise (MOD-P)
Intervention Description
Patients will exercise until they experience moderate claudication pain (2 on the rating scale)
Intervention Type
Other
Intervention Name(s)
Maximal Claudication Pain Exercise (MAX-P)
Intervention Description
Patients will exercise until they experience maximal claudication pain (4 on the rating scale)
Primary Outcome Measure Information:
Title
Change in Maximal Walking Distance (MWD)
Description
Metres walked until maximal claudication pain
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
Change in Pain Free Walking Distance (PFWD)
Description
Metres walked pain free
Time Frame
12 and 24 weeks
Title
Adherence
Description
Recording the number of training sessions attended and successfully completed
Time Frame
24 weeks
Title
Change in Quality of Life
Description
King College 24-item Vascular Quality of life and walking impairment questionnaire
Time Frame
12 and 24 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) <90 mmHg
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 undergoing active cancer treatment
Those presenting with any significant comorbidities or contraindications to exercise testing or training in accordance to the American College of Sports Medicine
Unstable/uncontrolled coronary heart 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Birkett, PHD
Organizational Affiliation
University of Central Lancashire
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Sport and and Health Sciences
City
Preston
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35762773
Citation
Birkett ST, Sinclair J, Seed SA, Pymer S, Caldow E, Ingle L, Harwood AE, Egun A. Effects of exercise prescribed at different levels of claudication pain on walking performance in patients with intermittent claudication: a protocol for a randomised controlled trial. Ther Adv Cardiovasc Dis. 2022 Jan-Dec;16:17539447221108817. doi: 10.1177/17539447221108817.
Results Reference
derived
Learn more about this trial
The Effects of Claudication Severity on Functional Outcomes
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