NCT04370327

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 5, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

3.5 years

First QC Date

April 23, 2020

Last Update Submit

November 1, 2022

Conditions

Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

  • Change in Maximal Walking Distance (MWD)

    Metres walked until maximal claudication pain

    12 and 24 weeks

Secondary Outcomes (3)

  • Change in Pain Free Walking Distance (PFWD)

    12 and 24 weeks

  • Adherence

    24 weeks

  • Change in Quality of Life

    12 and 24 weeks

Study Arms (3)

Pain Free Exercise (PF)

ACTIVE COMPARATOR

Patients will be randomised to twice weekly for 24 weeks of pain free exercise in a supervised exercise programme

Other: Pain Free Exercise (PF)

Moderate Claudication Pain Exercise (MOD-P)

ACTIVE COMPARATOR

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)

Maximal Claudication Pain Exercise (MAX-P)

ACTIVE COMPARATOR

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)

Interventions

Pain Free Exercise (PF)OTHER

Patients will exercise until the onset on claudication (1 on the rating scale)

Pain Free Exercise (PF)
Moderate Claudication Pain Exercise (MOD-P)OTHER

Patients will exercise until they experience moderate claudication pain (2 on the rating scale)

Moderate Claudication Pain Exercise (MOD-P)
Maximal Claudication Pain Exercise (MAX-P)OTHER

Patients will exercise until they experience maximal claudication pain (4 on the rating scale)

Maximal Claudication Pain Exercise (MAX-P)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sport and and Health Sciences

Preston, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35762773DERIVED

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan Birkett, PHD

    University of Central Lancashire

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Birkett, PhD

CONTACT

01772 893325SBirkett4@uclan.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer In Exercise Science

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 30, 2020

Study Start

July 5, 2021

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)