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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04370327
Other study ID # UCentalLancashirePAD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 5, 2021
Est. completion date January 2025

Study information

Verified date November 2022
Source University of Central Lancashire
Contact Stefan Birkett, PhD
Phone 01772 893325
Email SBirkett4@uclan.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 51
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Pain Free Exercise (PF)
Patients will exercise until the onset on claudication (1 on the rating scale)
Moderate Claudication Pain Exercise (MOD-P)
Patients will exercise until they experience moderate claudication pain (2 on the rating scale)
Maximal Claudication Pain Exercise (MAX-P)
Patients will exercise until they experience maximal claudication pain (4 on the rating scale)

Locations

Country Name City State
United Kingdom School of Sport and and Health Sciences Preston

Sponsors (1)

Lead Sponsor Collaborator
University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Maximal Walking Distance (MWD) Metres walked until maximal claudication pain 12 and 24 weeks
Secondary Change in Pain Free Walking Distance (PFWD) Metres walked pain free 12 and 24 weeks
Secondary Adherence Recording the number of training sessions attended and successfully completed 24 weeks
Secondary Change in Quality of Life King College 24-item Vascular Quality of life and walking impairment questionnaire 12 and 24 weeks
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