High Intensity Interval Training In pATiEnts With Intermittent Claudication

Not Applicable

Completed

Conditions: Intermittent Claudication
Peripheral Arterial Disease

Interventions: Other: High-intensity interval training

Registration Number: NCT04042311

Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Brief Summary: This INITIATE study evaluates the use of high-intensity interval training as a treatment modality for patients with intermittent claudication - an ambulatory leg pain caused by narrowed arteries that supply the lower limbs.

It is an observational cohort study considering high-intensity interval training (HIIT) as a treatment for intermittent claudication, consisting of two workstreams. Workstream 1: an initial observational cohort study to consider the feasibility of the intervention and exclusion criteria. Workstream 2: a proof of concept study utilising the altered intervention and exclusion criteria following recommendations highlighted during workstream 1.

Detailed Description: Patients with peripheral vascular disease (PVD) may develop a reproducible pain in their legs when they walk, which usually subsides with rest. This is known as intermittent claudication (IC) and is caused by a reduced blood supply to the legs as a result of narrowed or hardened arteries that supply the lower limbs. This ambulatory pain impedes on activities of daily living, functional capacity and quality of life.

National Institute for Health and Care Excellence (NICE) clinical guidance recommends a 12-week supervised exercise programme as first-line treatment for IC, whereby patients are encouraged to walk to the point of maximal pain. Robust clinical trials have demonstrated that supervised exercise programmes are efficacious for improving both pain-free and maximal walking distances, whilst also potentially improving quality of life.

Despite this, supervised exercise programmes are vastly under-utilised and not always available to consultant vascular surgeons. This means that further programmes need to be developed in order to provide a range of options to patients to improve uptake and adherence rates. One such programme is a 6-week high-intensity interval training programme.

An initial observational cohort study of the 6 week HIIT programme will be conducted to determine to determine the feasibility of the intervention and inclusion criteria. The results from this will be used to make any necessary changes to the HIIT intervention before moving into a proof of concept study, considering the utility, safety, acceptability and potential clinical efficacy of this programme.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-Intensity interval training	High-intensity interval training	High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.

Primary Outcome Measures

Name	Time	Method
Tolerability Test - Related Withdrawals	From the first to last exercise session, i.e. from week 0 to week 6.	Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
Feasibility Test	From study opening to completion/withdrawal of the last patient	Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed.
Tolerability Test - Achieving the Required Intensity	From the first to last exercise session, i.e. from week 0 to week 6.	Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session
Tolerability Test - Number of Sessions Completed	From the first to last exercise session, i.e. from week 0 to week 6.	Considers the number of sessions completed compared to the theoretical number.
Tolerability Test - Number of HIIT Intervals Completed	From the first to last exercise session, i.e. from week 0 to week 6.	Considers the number of HIIT intervals completed compared to the theoretical number.

Secondary Outcome Measures

Name	Time	Method
Maximum Walking Distance	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.	assessment of the distance that the patient can currently walk before having to stop due to claudication pain.
Safety Events Recorded	From enrolment to completion of 12-week follow-up	Defined as the occurrence of any adverse or serious adverse events related to the intervention.
Acceptability Testing	post-intervention follow-up, i.e. week 6.	An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
Peak Oxygen Uptake	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.	Peak oxygen uptake assessed via cardiopulmonary exercise testing
Quality of Life Questionnaire Short-form-36 (SF-36)	4 weeks (week 10) and 12 weeks (week 18) post-intervention	Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Vascular Quality of Life Questionnaire - (VascuQol)	4 weeks (week 10) and 12 weeks (week 18) post-intervention.	VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Ankle-Brachial Pressure Index	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.	The index or ratio of the pressure in the ankle compared with the arm.
Peak Power Output	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.	Peak power output assessed via CPET
Pain-free Walking Distance	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.	assessment of the distance that the patient can currently walk before experiencing claudication pain.
Ventilatory Anaerobic Threshold (VAT)	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.	Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing