18 and older, any sex, with Peripheral Arterial Disease or Intermittent Claudication. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Tolerability Test - Related WithdrawalsPrimary· From the first to last exercise session, i.e. from week 0 to week 6.
Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
Workstream 1 - unable to tolerate HIIT or CPEX
Group
Value
95% CI
High-Intensity Interval Training
1
Workstream 2 - unable to tolerate HIIT or CPEX
Group
Value
95% CI
High-Intensity Interval Training
3
Feasibility TestPrimary· From study opening to completion/withdrawal of the last patient
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.
Workstream 1 - screened
Group
Value
95% CI
High-Intensity Interval Training
144
Workstream 1 - eligible
Group
Value
95% CI
High-Intensity Interval Training
95
Workstream 1 - recruited
Group
Value
95% CI
High-Intensity Interval Training
30
Workstream 1 - completed
Group
Value
95% CI
High-Intensity Interval Training
15
Workstream 2 - screened
Group
Value
95% CI
High-Intensity Interval Training
280
Workstream 2 - eligible
Group
Value
95% CI
High-Intensity Interval Training
165
Workstream 2 - recruited
Group
Value
95% CI
High-Intensity Interval Training
40
Workstream 2 - completed
Group
Value
95% CI
High-Intensity Interval Training
31
Tolerability Test - Achieving the Required IntensityPrimary· From the first to last exercise session, i.e. from week 0 to week 6.
Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session
Workstream 1 - intervals at the required intensity
Group
Value
95% CI
High-Intensity Interval Training
2210
Workstream 2 - intervals at the required intensity
Group
Value
95% CI
High-Intensity Interval Training
4546
Tolerability Test - Number of Sessions CompletedPrimary· From the first to last exercise session, i.e. from week 0 to week 6.
Considers the number of sessions completed compared to the theoretical number.
Workstream 1 - HIIT sessions completed
Group
Value
95% CI
High-Intensity Interval Training
270
Workstream 2 - HIIT sessions completed
Group
Value
95% CI
High-Intensity Interval Training
551
Tolerability Test - Number of HIIT Intervals CompletedPrimary· From the first to last exercise session, i.e. from week 0 to week 6.
Considers the number of HIIT intervals completed compared to the theoretical number.
Workstream 1 - HIIT intervals completed
Group
Value
95% CI
High-Intensity Interval Training
234
Workstream 2 - HIIT intervals completed
Group
Value
95% CI
High-Intensity Interval Training
475
Safety Events RecordedSecondary· From enrolment to completion of 12-week follow-up
Defined as the occurrence of any adverse or serious adverse events related to the intervention.
Workstream 1
Group
Value
95% CI
High-Intensity Interval Training
3
Workstream 2
Group
Value
95% CI
High-Intensity Interval Training
9
Acceptability TestingSecondary· 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.
Group
Value
95% CI
High-Intensity Interval Training
23
Maximum Walking DistanceSecondary· 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.
Workstream 1 baseline
Group
Value
95% CI
High-Intensity Interval Training
243.8
± 102.2
Workstream 1 Post-intervention follow-up
Group
Value
95% CI
High-Intensity Interval Training
365.2
± 153.6
Workstream 1 - 4-week post intervention follow-up
Group
Value
95% CI
High-Intensity Interval Training
365.4
± 172.3
Workstream 1 - 12-week post intervention follow-up
Group
Value
95% CI
High-Intensity Interval Training
374.2
± 233.4
Workstream 2 baseline
Group
Value
95% CI
High-Intensity Interval Training
366.5
± 201.0
Workstream 2 Post-intervention follow-up
Group
Value
95% CI
High-Intensity Interval Training
455.0
± 220.8
Workstream 2 - 4-week post intervention follow-up
Group
Value
95% CI
High-Intensity Interval Training
450.7
± 242.8
Workstream 2 - 12-week post intervention follow-up
Group
Value
95% CI
High-Intensity Interval Training
448.1
± 240.9
Peak Oxygen UptakeSecondary· Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Peak oxygen uptake assessed via cardiopulmonary exercise testing
Quality of Life Questionnaire Short-form-36 (SF-36)Secondary· Baseline and post-intervention (week 6)
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.
Workstream 1 baseline physical functioning
Group
Value
95% CI
High-Intensity Interval Training
50.1
± 18.2
Workstream 1 follow-up physical functioning
Group
Value
95% CI
High-Intensity Interval Training
54.7
± 20.2
Workstream 1 baseline role physical
Group
Value
95% CI
High-Intensity Interval Training
52.5
± 26.9
Workstream 1 follow-up role physical
Group
Value
95% CI
High-Intensity Interval Training
55.4
± 27.7
Workstream 1 baseline pain
Group
Value
95% CI
High-Intensity Interval Training
47.9
± 13.9
Workstream 1 follow-up pain
Group
Value
95% CI
High-Intensity Interval Training
50.0
± 22.6
Workstream 1 baseline general health
Group
Value
95% CI
High-Intensity Interval Training
46.6
± 19.9
Workstream 1 follow-up general health
Group
Value
95% CI
High-Intensity Interval Training
52.7
± 20.8
Vascular Quality of Life Questionnaire - (VascuQol)Secondary· Baseline and post-intervention (week 6) follow-up
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25.
Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Workstream 1 baseline pain score
Group
Value
95% CI
High-Intensity Interval Training
4.2
± 1.3
Workstream 1 follow-up pain score
Group
Value
95% CI
High-Intensity Interval Training
4.4
± 1.5
Workstream 1 baseline social score
Group
Value
95% CI
High-Intensity Interval Training
5.5
± 1.7
Workstream 1 follow-up social score
Group
Value
95% CI
High-Intensity Interval Training
5.7
± 1.0
Workstream 1 baseline activities score
Group
Value
95% CI
High-Intensity Interval Training
4.4
± 1.2
Workstream 1 follow-up activities score
Group
Value
95% CI
High-Intensity Interval Training
4.6
± 1.0
Workstream 1 baseline symptom score
Group
Value
95% CI
High-Intensity Interval Training
5.5
± 0.6
Workstream 1 follow-up symptom score
Group
Value
95% CI
High-Intensity Interval Training
5.8
± 0.6
Ankle-Brachial Pressure IndexSecondary· 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.
Time frame: From enrollment to 18 weeks later for each patient..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07397702 — Effects of HIIT and MICT Training on Cardiorespiratory Fitness, Testosterone/Cortisol Ratio, and Mental Health in Young
· NA
· not yet recruiting
NCT07132385 — Feasibility of Different Types of Exercise Training in Perimenopausal Females
· NA
· recruiting
NCT06474832 — High Intensity Interval Training in Chronic Stroke
· NA
· recruiting
NCT07215533 — Effects of HIIT vs. TRE on Type 2 Diabetes Risk
· NA
· recruiting
NCT06374732 — The Benefits of a High-intensity Interval Training Intervention Delivered in a School Setting Among Adolescents
· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hull University Teaching Hospitals NHS Trust
Last refreshed: 14 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04042311.