N/A Completed N=70 Treatment

High Intensity Interval Training In pATiEnts With Intermittent Claudication

Peripheral arterial disease · Intermittent Claudication

Source: ClinicalTrials.gov NCT04042311 ↗

Enrolled (actual)

Serious AEs

1.4%

Results posted

Nov 2024

Primary outcomePrimary: Tolerability Test - Related Withdrawals — 1; 3 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Tolerability Test - Related Withdrawals	1; 3	—
PRIMARY Feasibility Test	144; 95; 30; 15; 280; 165	—
PRIMARY Tolerability Test - Achieving the Required Intensity	2210; 4546	—
PRIMARY Tolerability Test - Number of Sessions Completed	270; 551	—
PRIMARY Tolerability Test - Number of HIIT Intervals Completed	234; 475	—
SECONDARY Safety Events Recorded	3; 9	—
SECONDARY Acceptability Testing	23	—
SECONDARY Maximum Walking Distance	243.8; 365.2; 365.4; 374.2; 366.5; 455.0	—
SECONDARY Peak Oxygen Uptake	15.4; 15.9; 15.8; 15.3; 16.4; 17.1	—
SECONDARY Quality of Life Questionnaire Short-form-36 (SF-36)	61.9; 64.1; 61.5; 62.5; 53.2; 54.1	—
SECONDARY Vascular Quality of Life Questionnaire - (VascuQol)	4.7; 5.4; 6.3; 6.4; 5.2; 5.2	—
SECONDARY Ankle-Brachial Pressure Index	0.76; 0.78; 0.74; 0.80; 0.74; 0.76	—
SECONDARY Peak Power Output	94.9; 103.7; 98.7; 102.7; 101.6; 106.0	—
SECONDARY Pain-free Walking Distance	114.1; 141.3; 172.4; 216.3; 142.5; 218.6	—
SECONDARY Ventilatory Anaerobic Threshold (VAT)	9.8; 10.2; 10.0; 9.4; 10.0; 10.4	—

Eligibility Criteria

Workstream 1

Inclusion criteria

Aged >18 years
Ankle-brachial pressure index (ABPI) 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 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04042311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.