Clinical trial NCT04042311: High Intensity Interval Training In pATiEnts With Intermittent Claudication
Official title: High Intensity Interval Training In pATiEnts With Intermittent Claudication (INITIATE): a Proof-of-concept Prospective Cohort Study to Assess Acceptability, Feasibility and Potential Clinical Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Keywords: Exercise
High-intensity interval training
interval training
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2019-08-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Workstream 1: An initial single group cohort of 30 patients will be recruited and analysed to refine/alter the intervention and exclusion criteria based on its feasibility.

Workstream 2: This altered intervention and inclusion criteria will be considered in a further proof of concept study which will be multi-centre aiming to recruit a further x40 patients.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Tolerability Test - Related Withdrawals
timeFrame: From the first to last exercise session, i.e. from week 0 to week 6.
measure: Feasibility Test
timeFrame: From study opening to completion/withdrawal of the last patient
measure: Tolerability Test - Achieving the Required Intensity
timeFrame: From the first to last exercise session, i.e. from week 0 to week 6.
measure: Tolerability Test - Number of Sessions Completed
timeFrame: From the first to last exercise session, i.e. from week 0 to week 6.
measure: Tolerability Test - Number of HIIT Intervals Completed
timeFrame: From the first to last exercise session, i.e. from week 0 to week 6.
Secondary outcomes:
measure: Safety Events Recorded
timeFrame: From enrolment to completion of 12-week follow-up
measure: Acceptability Testing
timeFrame: post-intervention follow-up, i.e. week 6.
measure: Maximum Walking Distance
timeFrame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
measure: Peak Oxygen Uptake
timeFrame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
measure: Quality of Life Questionnaire Short-form-36 (SF-36)
timeFrame: Baseline and post-intervention (week 6)
measure: Vascular Quality of Life Questionnaire - (VascuQol)
timeFrame: Baseline and post-intervention (week 6) follow-up
measure: Ankle-Brachial Pressure Index
timeFrame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
measure: Peak Power Output
timeFrame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
measure: Pain-free Walking Distance
timeFrame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
measure: Ventilatory Anaerobic Threshold (VAT)
timeFrame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
measure: Quality of Life Questionnaire Short-form-36 (SF-36)
timeFrame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention
measure: Vascular Quality of Life Questionnaire - (VascuQol)
timeFrame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower Block
Study officials:
affiliation: Academic Vascular Surgical Unit, Hull York Medical School
name: Sean Pymer, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pymer S, Harwood AE, Ibeggazene S, McGregor G, Huang C, Nicholls AR, Ingle L, Long J, Rooms M, Chetter IC, Twiddy M. High INtensity Interval Training in pATiEnts with Intermittent Claudication: A Qualitative Acceptability Study. Ann Vasc Surg. 2024 May;102:17-24. doi: 10.1016/j.avsg.2023.11.043. Epub 2024 Jan 30.
citation: Pymer S, Harwood AE, Prosser J, Waddell A, Rhavindhran B, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, He H, Long J, Rooms M, Chetter IC. High-intensity interval training in patients with intermittent claudication. J Vasc Surg. 2023 Oct;78(4):1048-1056.e4. doi: 10.1016/j.jvs.2023.05.045. Epub 2023 Jun 16.
citation: Pymer S, Ibeggazene S, Palmer J, Smith GE, Harwood AE, Carroll S, Ingle L, Chetter IC. Considering the Feasibility, Tolerability, and Safety of High-Intensity Interval Training as a Novel Treatment for Patients With Intermittent Claudication. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):188-193. doi: 10.1097/HCR.0000000000000551.
citation: Pymer S, Harwood A, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, Long J, Rooms M, Chetter IC; INITIATE investigator group. High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study. BMJ Open. 2020 Jul 6;10(7):e038825. doi: 10.1136/bmjopen-2020-038825.