High Intensity Interval Training In pATiEnts With Intermittent Claudication

Hull University Teaching Hospitals NHS Trust70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Workstream 1 Inclusion criteria: * Aged \>18 years * Ankle-brachial pressure index (ABPI) \<0.9 at rest or a systolic pressure drop of ≥20mmHg at the ankle after exercise testing * Ability to walk unaided * English speaking and able to comply with exercise instructions Exclusion criteria: * Unable to provide informed consent * Critical limb threatening ischaemia / rest pain / tissue loss * Active cancer treatment * Significant comorbidities precluding safe participation in exercise testing and / or training according to the American College of Sports Medicine (ACSM) guidelines (28) * Resting/uncontrolled tachycardia (\>100 beats per minute \[bpm\]) and/or resting/uncontrolled hypertension (systolic blood pressure \>180 millimetres of mercury \[mmHg\] or diastolic blood pressure \>100mmHg) * Symptomatic hypotension Additional exclusion criteria: Following baseline cardiopulmonary exercise test (CPET), patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of: * Exercise-induced myocardial ischaemia or significant haemodynamic compromise (manifesting as anginal symptoms, significant ECG changes or an abnormal blood pressure response). * An inability to complete a maximal effort CPET Workstream 2: Inclusion criteria: * Aged \>18 years * ABPI \<0.9 at rest or a systolic pressure drop of ≥20mmHg at the ankle after exercise testing * Ability to walk unaided * English speaking and able to comply with exercise instructions Exclusion criteria: * Unable to provide informed consent * Critical limb threatening ischaemia / rest pain / tissue loss * Active cancer treatment * Significant comorbidities precluding safe participation in exercise testing and / or training according to the American College of Sports Medicine (ACSM) guidelines (28) * Resting/uncontrolled tachycardia (\>100bpm) and/or resting/uncontrolled hypertension (systolic blood pressure \>180mmHg or diastolic blood pressure \>100mmHg) * Symptomatic hypotension Additional exclusion criteria: Following baseline CPET, patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of: ● Exercise-induced myocardial ischaemia or significant haemodynamic compromise (manifesting as anginal symptoms, significant ECG changes or an abnormal blood pressure response).

Outcomes

Primary Outcomes

Tolerability Test - Related Withdrawals

Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).

Time frame: From the first to last exercise session, i.e. from week 0 to week 6.

Feasibility Test

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.

Time frame: From study opening to completion/withdrawal of the last patient

Tolerability Test - Achieving the Required Intensity

Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session

Time frame: From the first to last exercise session, i.e. from week 0 to week 6.

Tolerability Test - Number of Sessions Completed

Considers the number of sessions completed compared to the theoretical number.

Time frame: From the first to last exercise session, i.e. from week 0 to week 6.

Tolerability Test - Number of HIIT Intervals Completed

Considers the number of HIIT intervals completed compared to the theoretical number.

Time frame: From the first to last exercise session, i.e. from week 0 to week 6.

Secondary Outcomes

Safety Events Recorded

Defined as the occurrence of any adverse or serious adverse events related to the intervention.

Time frame: From enrolment to completion of 12-week follow-up

Acceptability Testing

An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.

Time frame: post-intervention follow-up, i.e. week 6.

Maximum Walking Distance

assessment of the distance that the patient can currently walk before having to stop due to claudication pain.

Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

Peak Oxygen Uptake

Peak oxygen uptake assessed via cardiopulmonary exercise testing

Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

Quality of Life Questionnaire Short-form-36 (SF-36)

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.

Time frame: Baseline and post-intervention (week 6)

Vascular Quality of Life Questionnaire - (VascuQol)

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.

Time frame: Baseline and post-intervention (week 6) follow-up

Ankle-Brachial Pressure Index

The index or ratio of the pressure in the ankle compared with the arm.

Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

Peak Power Output

Peak power output assessed via CPET

Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

Pain-free Walking Distance

assessment of the distance that the patient can currently walk before experiencing claudication pain.

Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

Ventilatory Anaerobic Threshold (VAT)

Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing

Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

Quality of Life Questionnaire Short-form-36 (SF-36)

Time frame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention

Vascular Quality of Life Questionnaire - (VascuQol)

Time frame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

High Intensity Interval Training In pATiEnts With Intermittent Claudication

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes