Considering the Feasibility, Tolerability, and Safety of High-Intensity Interval Training as a Novel Treatment for Patients With Intermittent Claudication

AbstractBackgroundUptake and completion rates for supervised exercise programmes (SEP) for patients with intermittent claudication (IC) are low. Current exercise prescription is a one size fits all approach, based on claudication pain thresholds, potentially limiting individual benefits. High-intensity interval training (HIIT) has the potential to overcome these barriers as it is a more time-efficient, objectively prescribed exercise programme. This study aimed to assess a novel HIIT programme for patients with IC in terms of safety, feasibility, tolerability and indicators of efficacy.Design/MethodsPatients referred to a usual-care SEP were invited to undertake an alternative HIIT programme. All recruited patients performed a baseline cardiopulmonary exercise test (CPET), to inform their exercise prescription. HIIT involved ten, one-minute high-intensity intervals on a stationary cycle ergometer interspersed with one-minute recovery intervals, performed three times per week for six-weeks. Outcomes included safety, feasibility, tolerability, walking distance and quality of life (QoL).Results144 patients with IC were referred, 95 met initial eligibility criteria (66%) and 30 (32%) were recruited for HIIT, of which 15 (50%) completed. Of the recruited patients, 90% were on optimal medical therapy and 40% had concomitant cardiac, cerebrovascular and/or respiratory disease.One serious adverse event was recorded and patients who completed the programme attended 100% of the sessions. Improvements in walking distances and quality of life were observed. Following recruitment of the first 20 patients, the inclusion criteria was refined on the basis of CPET, leading to improved completion rates.ConclusionThe study provides preliminary findings indicating that patients with IC can complete a short-term HIIT programme. HIIT also appears safe, well-tolerated and although not formally powered, walking distances and QoL appear to improve following HIIT. Further research to evaluate the role of HIIT in patients with IC seems warranted.

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

BMJ Open ◽

10.1136/bmjopen-2020-038825 ◽

2020 ◽

Vol 10 (7) ◽

pp. e038825

Author(s):

Sean Pymer ◽

Amy Harwood ◽

Said Ibeggazene ◽

Gordon McGregor ◽

Chao Huang ◽

...

Keyword(s):

Intermittent Claudication ◽

High Intensity ◽

Interval Training ◽

Walking Distance ◽

Peak Power Output ◽

Service Research ◽

Proof Of Concept ◽

High Intensity Interval Training ◽

Supervised Exercise ◽

High Intensity Interval

IntroductionThe 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 analysisThis 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 disseminationEthical 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 numberNCT04042311; Pre-results.

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