INITIATE: High Intensity Interval Training In pATiEnts With Intermittent Claudication

Sponsor

Hull University Teaching Hospitals NHS Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04042311

Collaborator

University of Hull (Other)

Enrollment

Location

Arm

54.4

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Intermittent Claudication	Other: High-intensity interval training	N/A

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 15, 2018

Anticipated Primary Completion Date :

Sep 28, 2022

Anticipated Study Completion Date :

Dec 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-Intensity interval training High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.	Other: High-intensity interval training a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike.

Arm

Intervention/Treatment

Experimental: High-Intensity interval training

High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.

Other: High-intensity interval training

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

Outcome Measures

Primary Outcome Measures

Safety Events Recorded [From enrolment to completion of 12-week follow-up]
Defined as the occurrence of any adverse or serious adverse events.
Tolerability Test [From the first to last exercise session, i.e. from week 0 to week 6.]
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.
Feasibility Test [From study opening to recruitment to completion of last patient last visit i.e. 29 weeks]
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.

Secondary Outcome Measures

Acceptability testing [post-intervention follow-up, i.e. week 6.]
An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
Maximum walking distance [Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.]
assessment of the distance that the patient can currently walk before having to stop due to claudication pain.
Pain-free walking distance [Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.]
assessment of the distance that the patient can currently walk before experiencing claudication pain.
Physiological parameters [Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.]
Physiological variables via cardiopulmonary exercise test to assess peak oxygen uptake and ventilatory anaerobic threshold
Quality of Life Questionnaire SF-36 [Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.]
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.
Quality of Life Questionnaire - VascuQol [Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.]
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.
Ankle-Brachial Pressure Index [Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.]
The index or ratio of the pressure in the ankle compared with the arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).