Status:
COMPLETED
High Intensity Interval Training In pATiEnts With Intermittent Claudication
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust
Collaborating Sponsors:
University of Hull
Conditions:
Peripheral Arterial Disease
Intermittent Claudication
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 c...
Eligibility Criteria
Inclusion
- 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- Following baseline cardiopulmonary exercise test (CPET), patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of: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).
Exclusion
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04042311
Start Date
June 15 2018
End Date
July 4 2022
Last Update
November 14 2024
Active Locations (1)
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1
Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower Block
Hull, United Kingdom, HU3 2JZ