High Intensity Interval Training In pATiEnts With Intermittent Claudication

Peripheral Arterial Disease Clinical Trial

— INITIATE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042311
• Other study ID #: R2219
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: December 28, 2022

Study information

• Verified date: November 2022
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: Sean Pymer, MSc
• Phone: 01482 674643
• Email: sean.pymer[@]hey.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• High-intensity interval training
a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike.

Locations

Country	Name	City	State
United Kingdom	Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower Block	Hull

Sponsors (2)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust	University of Hull

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Pymer S, Palmer J, Harwood AE, Ingle L, Smith GE, Chetter IC. A systematic review of high-intensity interval training as an exercise intervention for intermittent claudication. J Vasc Surg. 2019 Dec;70(6):2076-2087. doi: 10.1016/j.jvs.2019.03.050. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Events Recorded	Defined as the occurrence of any adverse or serious adverse events.	From enrolment to completion of 12-week follow-up
Primary	Tolerability Test	Defined by examining the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session and examining reasons for withdrawal and whether or not they were related to the intervention. Tolerability will also consider the number of patients able to achieve a maximal effort CPET.	From the first to last exercise session, i.e. from week 0 to week 6.
Primary	Feasibility Test	Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed.	From study opening to recruitment to completion of last patient last visit i.e. 29 weeks
Secondary	Acceptability testing	An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.	post-intervention follow-up, i.e. week 6.
Secondary	Maximum walking distance	assessment of the distance that the patient can currently walk before having to stop due to claudication pain.	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Secondary	Pain-free walking distance	assessment of the distance that the patient can currently walk before experiencing claudication pain.	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Secondary	Physiological parameters	Physiological variables via cardiopulmonary exercise test to assess peak oxygen uptake and ventilatory anaerobic threshold	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Secondary	Quality of Life Questionnaire SF-36	Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Secondary	Quality of Life Questionnaire - VascuQol	Patient reported quality of life using VascuQoL VascuQol is a Vascular specific QoL tool, It measures across 4 domains and gives a total score ranging from 0-7 with a higher score indicating better Vascular specific quality of life.	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Secondary	Ankle-Brachial Pressure Index	The index or ratio of the pressure in the ankle compared with the arm.	Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.