The Effects of Claudication Severity on Functional Outcomes

The Effects of Claudication Severity on Functional Outcomes in Patients With Intermittent Claudication

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

Study Overview

• Status: Recruiting
• Conditions: Intermittent Claudication
• Intervention / Treatment: Other: Pain Free Exercise (PF); Other: Moderate Claudication Pain Exercise (MOD-P); Other: Maximal Claudication Pain Exercise (MAX-P)

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

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Birkett, PhD; Phone Number: 01772 893325; Email: SBirkett4@uclan.ac.uk

Study Locations

• United Kingdom
  • Preston, United Kingdom
    • Recruiting
    • School of Sport and and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. >18 years old
2. Resting ankle brachial pressure index (ABPI) <90 mmHg
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 undergoing active cancer treatment
4. Those presenting with any significant comorbidities or contraindications to exercise testing or training in accordance to the American College of Sports Medicine
5. Unstable/uncontrolled coronary heart disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pain Free Exercise (PF); Patients will be randomised to twice weekly for 24 weeks of pain free exercise in a supervised exercise programme	Other: Pain Free Exercise (PF); Patients will exercise until the onset on claudication (1 on the rating scale)
Active Comparator: Moderate Claudication Pain Exercise (MOD-P); Patients will be randomised to twice weekly for 24 weeks of moderate claudication pain exercise in a supervised exercise programme	Other: Moderate Claudication Pain Exercise (MOD-P); Patients will exercise until they experience moderate claudication pain (2 on the rating scale)
Active Comparator: Maximal Claudication Pain Exercise (MAX-P); Patients will be randomised to twice weekly for 24 weeks of maximal claudication pain exercise in a supervised exercise programme	Other: Maximal Claudication Pain Exercise (MAX-P); Patients will exercise until they experience maximal claudication pain (4 on the rating scale)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximal Walking Distance (MWD)	Metres walked until maximal claudication pain	12 and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Free Walking Distance (PFWD)	Metres walked pain free	12 and 24 weeks
Adherence	Recording the number of training sessions attended and successfully completed	24 weeks
Change in Quality of Life	King College 24-item Vascular Quality of life and walking impairment questionnaire	12 and 24 weeks

Collaborators and Investigators

• Sponsor: University of Central Lancashire
• Investigators: Principal Investigator: Stefan Birkett, PHD, University of Central Lancashire

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intermittent Claudication
• Other Study ID Numbers: UCentalLancashirePAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No