INITIATE

• Research type

  Research Study

• Full title

  High INtensity Interval Training in pATiEnts with intermittent claudication (INITIATE)

• IRAS ID

  237067

• Contact name

  Ian Chetter

• Contact email

  ian.chetter@hey.nhs.uk

• Sponsor organisation

  Hull and East Yorkshire NHS Trust

• Clinicaltrials.gov Identifier

  NCT04042311

• Duration of Study in the UK

  2 years, 3 months, 31 days

• Research summary

  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. Two such programmes are a 6-week high-intensity interval training programme and a 12-week home-based supported exercise programme.

  Aims: To identify the utility, safety, acceptability, tolerability and efficacy of HIIT and HEP as novel interventions vs current SEP to improve PFWD, MWD and VO2peak in patients suffering IC secondary to PAD.
  However, as a cycle-based HIIT protocol using an intensity >80% has not been previously investigated in the IC population, an initial observational cohort study of HIIT will be conducted to determine its safety, tolerability and acceptability. The results from this will be used to make any necessary changes to the HIIT intervention before moving into the three-arm trial.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  18/YH/0112

• Date of REC Opinion

  27 Apr 2018

• REC opinion

  Further Information Favourable Opinion