Peripheral Arterial Disease Clinical Trial
— INITIATEOfficial 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
NCT number | NCT04042311 |
Other study ID # | R2219 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 15, 2018 |
Est. completion date | December 28, 2022 |
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 28, 2022 |
Est. primary completion date | October 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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100mmHg) - Symptomatic hypotension Additional exclusion criteria: Following baseline CPET, patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of: - Exercise-induced myocardial ischaemia or significant haemodynamic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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower Block | Hull |
Lead Sponsor | Collaborator |
---|---|
Hull University Teaching Hospitals NHS Trust | University of Hull |
United Kingdom,
Pymer S, Palmer J, Harwood AE, Ingle L, Smith GE, Chetter IC. A systematic review of high-intensity interval training as an exercise intervention for intermittent claudication. J Vasc Surg. 2019 Dec;70(6):2076-2087. doi: 10.1016/j.jvs.2019.03.050. Epub 20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Events Recorded | Defined as the occurrence of any adverse or serious adverse events. | From enrolment to completion of 12-week follow-up | |
Primary | Tolerability Test | 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. | From the first to last exercise session, i.e. from week 0 to week 6. | |
Primary | Feasibility Test | 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. | From study opening to recruitment to completion of last patient last visit i.e. 29 weeks | |
Secondary | Acceptability testing | An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews. | post-intervention follow-up, i.e. week 6. | |
Secondary | Maximum walking distance | assessment of the distance that the patient can currently walk before having to stop due to claudication pain. | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | |
Secondary | Pain-free walking distance | assessment of the distance that the patient can currently walk before experiencing claudication pain. | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | |
Secondary | Physiological parameters | Physiological variables via cardiopulmonary exercise test to assess peak oxygen uptake and ventilatory anaerobic threshold | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | |
Secondary | Quality of Life Questionnaire SF-36 | 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. | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | |
Secondary | Quality of Life Questionnaire - VascuQol | 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. | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | |
Secondary | Ankle-Brachial Pressure Index | The index or ratio of the pressure in the ankle compared with the arm. | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
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