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Completed

NCT Number: NCT05059899

Home-based Circuit Training for People With Intermittent Claudication

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coventry University

Coventry, West Midlands, CV1 2DS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intervention feasibility assessed via recruitment rate

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

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

  2. Intervention feasibility assessed via attrition rate

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

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

  3. Intervention feasibility assessed via protocol adherence

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

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

  4. Intervention acceptability via participant interviews

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

    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.

Secondary outcomes

  1. 12 and 24 week change in six-minute walk distance and pain-free walk distance

    Time frame: Baseline to 12 weeks and 24 weeks

    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.

  2. 12 and 24 week change in pain-free and maximal treadmill walk distance

    Time frame: Baseline to 12 weeks and 24 weeks

    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.

  3. 12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer)

    Time frame: Baseline to 12 weeks and 24 weeks

    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.

  4. 12 and 24 week change in physical activity measured by accelerometer data

    Time frame: Baseline to 12 weeks and 24 weeks

    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.

  5. 12 and 24 week change in SF-36 score

    Time frame: Baseline to 12 weeks and 24 weeks

    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).

  6. 12 and 24 week change in VascuQol questionnaire score

    Time frame: Baseline to 12 weeks and 24 weeks

    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).

  7. 12 and 24 week change in EQ-5D-5L questionnaire score

    Time frame: Baseline to 12 weeks and 24 weeks

    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).

  8. 12 and 24 week change in circulating markers of inflammation

    Time frame: Baseline to 12 weeks and 24 weeks

    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.

  9. 12 and 24 week change in circulating markers of vascular remodelling

    Time frame: Baseline to 12 weeks and 24 weeks

    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.

Other outcomes

  1. 12 and 24 week change in rest times during a six-minute walk test

    Time frame: Baseline to 12 weeks and 24 weeks

    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.

  2. 12 and 24 week change in pain cessation following a treadmill test

    Time frame: Baseline to 12 weeks and 24 weeks

    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.

  3. 12 and 24 week changes in walking speed during a six-minute walk test

    Time frame: Baseline to 12 weeks and 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Coventry University

Other

Collaborators

  • University Hospitals Coventry and Warwickshire NHS Trust

Registry information

Official study title

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

Acronym: WALKSTRONG

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2021
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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