Home-based Circuit Training for People With Intermittent Claudication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2023-06-26

Brief Summary

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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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Detailed Description

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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.

Conditions

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Peripheral Artery Disease Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise group

Home-based circuit and community walking exercise

Group Type EXPERIMENTAL

Exercise group

Intervention Type 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.

Usual care

Usual activity/healthcare

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No