Home-based Circuit Training for People With Intermittent Claudication

NCT05059899 | Completed

• 1 other identifier: P123339
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication.

Conditions

Peripheral Artery Disease; Intermittent Claudication

Keywords

home-based exercise; circuit training; walking

Outcome Measures

Primary Outcomes (4)

• Intervention feasibility assessed via recruitment rate

  The investigators will record the number of eligible participants, as well as the number who enroll onto the study.

  Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)

• Intervention feasibility assessed via attrition rate

  The investigators will record the number of protocol discontinuations and losses to follow-up.

  Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)

• Intervention feasibility assessed via protocol adherence

  The investigators will examine discrepancies between intervention prescription and what is completed.

  Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)

• Intervention acceptability via participant interviews

  One-to-one interviews will be held between an investigator and participant who has either completed the intervention, withdrawn or declined participation, to ask questions regarding the intervention protocol.

  Will be evaluated after the intervention period (either at 12 week or 24 week follow up)

Secondary Outcomes (9)

• 12 and 24 week change in six-minute walk distance and pain-free walk distance

  Baseline to 12 weeks and 24 weeks

• 12 and 24 week change in pain-free and maximal treadmill walk distance

  Baseline to 12 weeks and 24 weeks

• 12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer)

  Baseline to 12 weeks and 24 weeks

• 12 and 24 week change in physical activity measured by accelerometer data

  Baseline to 12 weeks and 24 weeks

• 12 and 24 week change in SF-36 score

  Baseline to 12 weeks and 24 weeks

Other Outcomes (3)

• 12 and 24 week change in rest times during a six-minute walk test

  Baseline to 12 weeks and 24 weeks

• 12 and 24 week change in pain cessation following a treadmill test

  Baseline to 12 weeks and 24 weeks

• 12 and 24 week changes in walking speed during a six-minute walk test

  Baseline to 12 weeks and 24 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

Home-based circuit and community walking exercise

Behavioral: Exercise group

Usual care

NO INTERVENTION

Usual activity/healthcare

Interventions

Exercise group BEHAVIORAL

The exercise group will receive a 12-week home-based exercise programme, with a wearable activity watch to regulate physical activity behaviour. This group will also receive biweekly telephone calls from the investigator.

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ankle/brachial index (ABPI) \< 0.9 at rest or a drop of 20mmHg after exercise testing
• Ability to walk independently
• English speaking
• Able to follow instructions
• ≥ 18 years of age

You may not qualify if:

• Unable to provide informed consent
• Walking impairment for a reason that is not PAD
• Critical limb ischaemia
• Asymptomatic PAD
• Active cancer treatment
• Severe mental or physical limitations precluding participation safely in the home environment

Sponsors & Collaborators

• Coventry University: lead
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator

Study Sites (1)

Coventry University

Coventry, West Midlands, CV1 2DS, United Kingdom

Location

Related Publications (1)

• Waddell A, Denton F, Powell R, Broom DR, Birkett ST, McGregor G, Harwood AE. "It's put a routine and regimen in my life" - Participant experiences with a programme of community walking and home-based circuit training for intermittent claudication. J Vasc Nurs. 2024 Dec;42(4):276-281. doi: 10.1016/j.jvn.2024.09.003. Epub 2024 Sep 28.

  PMID: 39645388 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Waddell, MSc

  Coventry University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: May 9, 2022
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)