High Intensity Interval Training In pATiEnts With Intermittent Claudication (INITIATE)

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NHS Trust

Status

Enrolling

Conditions

Intermittent Claudication
Peripheral Arterial Disease

Treatments

Other: High-intensity interval training

Study type

Interventional

Funder types

Other

Identifiers

NCT04042311
R2219

Details and patient eligibility

About

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 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.

Full 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. 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Workstream 1

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).
  • 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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Sean Pymer, MSc

Data sourced from clinicaltrials.gov

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