Home-based Circuit Training for People With Intermittent Claudication (WALKSTRONG)

Community WALKing and Home-baSed circuiT tRaining in peOple liviNG With Intermittent Claudication (WALK-STRONG): a Randomised Controlled Feasibility Trial

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.

Study Overview

• Status: Completed
• Conditions: Intermittent Claudication; Peripheral Artery Disease
• Intervention / Treatment: Behavioral: Exercise group

Detailed Description

30 participants with PAD will be randomised to one of two groups: either exercise or usual care. The 12 week exercise intervention will consist of a home-based circuit programme, including both resistance exercises and walking. This will be combined with promoting free-living walking throughout the rest of the week. Exercise will be regulated via the use of a wearable activity monitor. Biweekly phone calls will address compliance with the intervention. The primary outcomes are feasibility and acceptability, which will be determined after 12 weeks via recruitment and attrition rates, protocol adherence and with participant interviews. Secondary outcomes include changes in pain-free and maximal walking distances with both a graded treadmill test and six-minute walk test, hand grip strength, physical activity behaviour (measured with an accelerometer), quality of life (measured with the SF-36, VascuQol and E5-5D-5L questionnaires) after 12 and 24 weeks. Investigators will also assess changes in markers of inflammation, vascular remodeling, mitochondrial biogenesis and oxidative stress at 12 and 24 weeks. Other outcomes include changes in time spent resting during a six-minute walk test and time to pain cessation following a graded treadmill test at 12 and 24 weeks.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV1 2DS
      • Coventry University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; Home-based circuit and community walking exercise	Behavioral: Exercise group; 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.
No Intervention: Usual care; Usual activity/healthcare

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 and 24 week change in six-minute walk distance and pain-free walk distance	Change in six-minute and pain-free walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group.	Baseline to 12 weeks and 24 weeks
12 and 24 week change in pain-free and maximal treadmill walk distance	Change in pain-free and maximal treadmill walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group.	Baseline to 12 weeks and 24 weeks
12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer)	Change in left and right hand grip strength after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group.	Baseline to 12 weeks and 24 weeks
12 and 24 week change in physical activity measured by accelerometer data	Change in physical activity behaviour at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group, using accelerometer data.	Baseline to 12 weeks and 24 weeks
12 and 24 week change in SF-36 score	Change in 36 Item Short Form survey scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 0-100, with higher scores associated with a better outcome).	Baseline to 12 weeks and 24 weeks
12 and 24 week change in VascuQol questionnaire score	Change in Vascular Quality of Life questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 1-7, with higher scores associated with a better outcome).	Baseline to 12 weeks and 24 weeks
12 and 24 week change in EQ-5D-5L questionnaire score	Change in European Quality of Life Five Dimension questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Scores range from 1-5, with lower scores associated with a better outcome).	Baseline to 12 weeks and 24 weeks
12 and 24 week change in circulating markers of inflammation	Investigators will compare blood sample measures of IL-6, TNF-α, CRP between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks.	Baseline to 12 weeks and 24 weeks
12 and 24 week change in circulating markers of vascular remodelling	Investigators will compare blood sample measures of VEGF between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks.	Baseline to 12 weeks and 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 and 24 week change in rest times during a six-minute walk test	Change in time spent resting during a six-minute walk test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group.	Baseline to 12 weeks and 24 weeks
12 and 24 week change in pain cessation following a treadmill test	Change in time to pain cessation following a treadmill test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group.	Baseline to 12 weeks and 24 weeks
12 and 24 week changes in walking speed during a six-minute walk test	Change in walking speed during a six-minute walk test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group.	Baseline to 12 weeks and 24 weeks

Collaborators and Investigators

• Sponsor: Coventry University
• Collaborators: University Hospitals Coventry and Warwickshire NHS Trust
• Investigators: Principal Investigator: Alexander Waddell, MSc, Coventry University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): June 26, 2023
• Study Completion (Actual): June 26, 2023

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: walking; circuit training; home-based exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: P123339

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