High Intensity Interval Training In pATiEnts With Intermittent Claudication
Peripheral Arterial Disease · Intermittent Claudication
Bottom Line
View on ClinicalTrials.gov: NCT04042311 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-intensity interval training (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hull University Teaching Hospitals NHS Trust
- Primary completion
- Apr 2022
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 | — |
| 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 | — |
Summary
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Following baseline cardiopulmonary exercise test (CPET), patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of: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).
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.