High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study

INITIATE investigator group

doi:10.1136/bmjopen-2020-038825

High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study

INITIATE investigator group

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Abstract

INTRODUCTION: The first-line recommended treatment for patients with intermittent claudication (IC) is a supervised exercise programme (SEP), which includes a minimum of 2-hours of exercise per week over a 12-week period. However, provision, uptake and adherence rates for these SEP programmes are poor, with time constraints cited as a common participant barrier. High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier. However, evidence is lacking for the role of HIIT in those with IC. This proof-of-concept study aims to consider the safety, feasibility, tolerability and acceptability of a HIIT programme for patients with IC.

METHODS AND ANALYSIS: This multicentre, single-group, prospective, interventional feasibility study will recruit 40 patients with IC, who will complete 6 weeks of HIIT, 3 times a week. HIIT will involve a supervised programme of 10×1 min high-intensity cycling intervals at 85%-90% peak power output (PPO), interspaced with 10×1 min low intensity intervals at 20%-25% PPO. PPO will be determined from a baseline cardiopulmonary exercise test (CPET) and it is intended that patients will achieve ≥85% of maximum heart rate from CPET, by the end of the second HIIT interval. Primary outcome measures are safety (occurrence of adverse events directly related to the study), programme feasibility (including participant eligibility, recruitment and completion rates) and HIIT tolerability (ability to achieve and maintain the required intensity). Secondary outcomes include patient acceptability, walking distance, CPET cardiorespiratory fitness measures and quality of life outcomes.

ETHICS AND DISSEMINATION: Ethical approval was obtained via a local National Health Service research ethics committee (Bradford Leeds - 18/YH/0112) and recruitment began in August 2019 and will be completed in October 2020. Results will be published in peer-reviewed journals and presented at international conferences and are expected to inform a future pilot randomised controlled trial of HIIT versus usual-care SEPs.

TRIAL REGISTRATION NUMBER: NCT04042311; Pre-results.

Original language	English
Article number	e038825
Number of pages	9
Journal	BMJ Open
Volume	10
Issue number	7
DOIs	https://doi.org/10.1136/bmjopen-2020-038825
Publication status	Published - 6 Jul 2020

Bibliographical note

This is an open access article distributed in accordance with the
Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits
others to copy, redistribute, remix, transform and build upon this work for any
purpose, provided the original work is properly cited, a link to the licence is given,
and indication of whether changes were made. See: https://creativecommons.org/
licenses/by/4.0/.

Funding

INITIATE will be conducted at two UK centres; 1. The Academic Vascular Surgical Unit, Hull Royal Infirmary, Kingston-Upon-Hull and 2. Atrium Health, Centre for Exercise and Health, Coventry and Warwickshire Hospitals National Health Service (NHS) Trust, Coventry. Sponsorship is provided by Hull University Teaching Hospitals NHS Trust and funding provided by the National Institute for Health Research, Research for Patient Benefit programme. Recruitment commenced in August 2019, with a recruitment target of 40 patients (20 per site). Recruitment is anticipated to be completed by October 2020. This work is supported by National Institute for Health Research, Research for Patient Benefit programme grant number PG-PB041820014.

Funders	Funder number
Hull University Teaching Hospitals NHS Trust
National Institute for Health and Care Research	PG-PB041820014

Keywords

rehabilitation medicine
vascular medicine
vascular surgery

ASJC Scopus subject areas

General Medicine

Access to Document

10.1136/bmjopen-2020-038825Licence: CC BY

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Cite this

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title = "High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study",

abstract = "INTRODUCTION: The first-line recommended treatment for patients with intermittent claudication (IC) is a supervised exercise programme (SEP), which includes a minimum of 2-hours of exercise per week over a 12-week period. However, provision, uptake and adherence rates for these SEP programmes are poor, with time constraints cited as a common participant barrier. High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier. However, evidence is lacking for the role of HIIT in those with IC. This proof-of-concept study aims to consider the safety, feasibility, tolerability and acceptability of a HIIT programme for patients with IC.METHODS AND ANALYSIS: This multicentre, single-group, prospective, interventional feasibility study will recruit 40 patients with IC, who will complete 6 weeks of HIIT, 3 times a week. HIIT will involve a supervised programme of 10×1 min high-intensity cycling intervals at 85\%-90\% peak power output (PPO), interspaced with 10×1 min low intensity intervals at 20\%-25\% PPO. PPO will be determined from a baseline cardiopulmonary exercise test (CPET) and it is intended that patients will achieve ≥85\% of maximum heart rate from CPET, by the end of the second HIIT interval. Primary outcome measures are safety (occurrence of adverse events directly related to the study), programme feasibility (including participant eligibility, recruitment and completion rates) and HIIT tolerability (ability to achieve and maintain the required intensity). Secondary outcomes include patient acceptability, walking distance, CPET cardiorespiratory fitness measures and quality of life outcomes.ETHICS AND DISSEMINATION: Ethical approval was obtained via a local National Health Service research ethics committee (Bradford Leeds - 18/YH/0112) and recruitment began in August 2019 and will be completed in October 2020. Results will be published in peer-reviewed journals and presented at international conferences and are expected to inform a future pilot randomised controlled trial of HIIT versus usual-care SEPs.TRIAL REGISTRATION NUMBER: NCT04042311; Pre-results.",

keywords = "rehabilitation medicine, vascular medicine, vascular surgery",

author = "\{INITIATE investigator group\} and Sean Pymer and Amy Harwood and Said Ibeggazene and Gordon McGregor and Chao Huang and Maureen Twiddy and Nicholls, \{Adam R\} and Lee Ingle and Sean Carroll and Judith Long and Marjorie Rooms and Chetter, \{I C\}",

note = "This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/.",

year = "2020",

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doi = "10.1136/bmjopen-2020-038825",

language = "English",

volume = "10",

journal = "BMJ Open",

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T1 - High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE)

T2 - protocol for a multicentre, proof-of-concept, prospective interventional study

AU - INITIATE investigator group

AU - Pymer, Sean

AU - Harwood, Amy

AU - Ibeggazene, Said

AU - McGregor, Gordon

AU - Huang, Chao

AU - Twiddy, Maureen

AU - Nicholls, Adam R

AU - Ingle, Lee

AU - Carroll, Sean

AU - Long, Judith

AU - Rooms, Marjorie

AU - Chetter, I C

N1 - This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/.

PY - 2020/7/6

Y1 - 2020/7/6

N2 - INTRODUCTION: The first-line recommended treatment for patients with intermittent claudication (IC) is a supervised exercise programme (SEP), which includes a minimum of 2-hours of exercise per week over a 12-week period. However, provision, uptake and adherence rates for these SEP programmes are poor, with time constraints cited as a common participant barrier. High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier. However, evidence is lacking for the role of HIIT in those with IC. This proof-of-concept study aims to consider the safety, feasibility, tolerability and acceptability of a HIIT programme for patients with IC.METHODS AND ANALYSIS: This multicentre, single-group, prospective, interventional feasibility study will recruit 40 patients with IC, who will complete 6 weeks of HIIT, 3 times a week. HIIT will involve a supervised programme of 10×1 min high-intensity cycling intervals at 85%-90% peak power output (PPO), interspaced with 10×1 min low intensity intervals at 20%-25% PPO. PPO will be determined from a baseline cardiopulmonary exercise test (CPET) and it is intended that patients will achieve ≥85% of maximum heart rate from CPET, by the end of the second HIIT interval. Primary outcome measures are safety (occurrence of adverse events directly related to the study), programme feasibility (including participant eligibility, recruitment and completion rates) and HIIT tolerability (ability to achieve and maintain the required intensity). Secondary outcomes include patient acceptability, walking distance, CPET cardiorespiratory fitness measures and quality of life outcomes.ETHICS AND DISSEMINATION: Ethical approval was obtained via a local National Health Service research ethics committee (Bradford Leeds - 18/YH/0112) and recruitment began in August 2019 and will be completed in October 2020. Results will be published in peer-reviewed journals and presented at international conferences and are expected to inform a future pilot randomised controlled trial of HIIT versus usual-care SEPs.TRIAL REGISTRATION NUMBER: NCT04042311; Pre-results.

AB - INTRODUCTION: The first-line recommended treatment for patients with intermittent claudication (IC) is a supervised exercise programme (SEP), which includes a minimum of 2-hours of exercise per week over a 12-week period. However, provision, uptake and adherence rates for these SEP programmes are poor, with time constraints cited as a common participant barrier. High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier. However, evidence is lacking for the role of HIIT in those with IC. This proof-of-concept study aims to consider the safety, feasibility, tolerability and acceptability of a HIIT programme for patients with IC.METHODS AND ANALYSIS: This multicentre, single-group, prospective, interventional feasibility study will recruit 40 patients with IC, who will complete 6 weeks of HIIT, 3 times a week. HIIT will involve a supervised programme of 10×1 min high-intensity cycling intervals at 85%-90% peak power output (PPO), interspaced with 10×1 min low intensity intervals at 20%-25% PPO. PPO will be determined from a baseline cardiopulmonary exercise test (CPET) and it is intended that patients will achieve ≥85% of maximum heart rate from CPET, by the end of the second HIIT interval. Primary outcome measures are safety (occurrence of adverse events directly related to the study), programme feasibility (including participant eligibility, recruitment and completion rates) and HIIT tolerability (ability to achieve and maintain the required intensity). Secondary outcomes include patient acceptability, walking distance, CPET cardiorespiratory fitness measures and quality of life outcomes.ETHICS AND DISSEMINATION: Ethical approval was obtained via a local National Health Service research ethics committee (Bradford Leeds - 18/YH/0112) and recruitment began in August 2019 and will be completed in October 2020. Results will be published in peer-reviewed journals and presented at international conferences and are expected to inform a future pilot randomised controlled trial of HIIT versus usual-care SEPs.TRIAL REGISTRATION NUMBER: NCT04042311; Pre-results.

KW - rehabilitation medicine

KW - vascular medicine

KW - vascular surgery

UR - https://www.scopus.com/pages/publications/85087669249

U2 - 10.1136/bmjopen-2020-038825

DO - 10.1136/bmjopen-2020-038825

M3 - Article

C2 - 32636290

SN - 2044-6055

VL - 10

JO - BMJ Open

JF - BMJ Open

IS - 7

M1 - e038825

ER -

High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

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