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High Intensity Interval Training In pATiEnts With Intermittent Claudication (INITIATE)

Primary Purpose

Peripheral Arterial Disease, Intermittent Claudication

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High-intensity interval training
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Exercise, High-intensity interval training, interval training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Following baseline CPET, patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of: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).

Sites / Locations

  • Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower BlockRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-Intensity interval training

Arm Description

High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.

Outcomes

Primary Outcome Measures

Safety Events Recorded
Defined as the occurrence of any adverse or serious adverse events.
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.
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.

Secondary Outcome Measures

Acceptability testing
An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
Maximum walking distance
assessment of the distance that the patient can currently walk before having to stop due to claudication pain.
Pain-free walking distance
assessment of the distance that the patient can currently walk before experiencing claudication pain.
Physiological parameters
Physiological variables via cardiopulmonary exercise test to assess peak oxygen uptake and ventilatory anaerobic threshold
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.
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.
Ankle-Brachial Pressure Index
The index or ratio of the pressure in the ankle compared with the arm.

Full Information

First Posted
July 11, 2019
Last Updated
November 3, 2022
Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
University of Hull
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1. Study Identification

Unique Protocol Identification Number
NCT04042311
Brief Title
High Intensity Interval Training In pATiEnts With Intermittent Claudication
Acronym
INITIATE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
October 28, 2022 (Anticipated)
Study Completion Date
December 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
University of Hull

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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 caused by a reduced blood supply to the legs as a result of narrowed or hardened arteries that supply the lower limbs. This ambulatory pain impedes on activities of daily living, functional capacity and quality of life. NICE clinical guidance recommends a 12-week supervised exercise programme as first-line treatment for IC, whereby patients are encouraged to walk to the point of maximal pain. Robust clinical trials have demonstrated that supervised exercise programmes are efficacious for improving both pain-free and maximal walking distances, whilst also potentially improving quality of life. Despite this, supervised exercise programmes are vastly under-utilised and not always available to consultant vascular surgeons. This means that further programmes need to be developed in order to provide a range of options to patients to improve uptake and adherence rates. One such programme is a 6-week high-intensity interval training programme. An initial observational cohort study of the 6 week HIIT programme will be conducted to determine to determine the feasibility of the intervention and inclusion criteria. The results from this will be used to make any necessary changes to the HIIT intervention before moving into a proof of concept study, considering the utility, safety, acceptability and potential clinical efficacy of this programme.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Intermittent Claudication
Keywords
Exercise, High-intensity interval training, interval training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Workstream 1: An initial single group cohort of 30 patients will be recruited and analysed to refine/alter the intervention and exclusion criteria based on its feasibility. Workstream 2: This altered intervention and inclusion criteria will be considered in a further proof of concept study which will be multi-centre aiming to recruit a further x40 patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-Intensity interval training
Arm Type
Experimental
Arm Description
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
Intervention Type
Other
Intervention Name(s)
High-intensity interval training
Intervention Description
a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike.
Primary Outcome Measure Information:
Title
Safety Events Recorded
Description
Defined as the occurrence of any adverse or serious adverse events.
Time Frame
From enrolment to completion of 12-week follow-up
Title
Tolerability Test
Description
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.
Time Frame
From the first to last exercise session, i.e. from week 0 to week 6.
Title
Feasibility Test
Description
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.
Time Frame
From study opening to recruitment to completion of last patient last visit i.e. 29 weeks
Secondary Outcome Measure Information:
Title
Acceptability testing
Description
An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
Time Frame
post-intervention follow-up, i.e. week 6.
Title
Maximum walking distance
Description
assessment of the distance that the patient can currently walk before having to stop due to claudication pain.
Time Frame
Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Title
Pain-free walking distance
Description
assessment of the distance that the patient can currently walk before experiencing claudication pain.
Time Frame
Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Title
Physiological parameters
Description
Physiological variables via cardiopulmonary exercise test to assess peak oxygen uptake and ventilatory anaerobic threshold
Time Frame
Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Title
Quality of Life Questionnaire SF-36
Description
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.
Time Frame
Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Title
Quality of Life Questionnaire - VascuQol
Description
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.
Time Frame
Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Title
Ankle-Brachial Pressure Index
Description
The index or ratio of the pressure in the ankle compared with the arm.
Time Frame
Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Pymer, MSc
Phone
01482 674643
Email
sean.pymer@hey.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Pymer, MSc
Organizational Affiliation
Academic Vascular Surgical Unit, Hull York Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower Block
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Pymer, MSc
First Name & Middle Initial & Last Name & Degree
Sean Pymer, MSc
First Name & Middle Initial & Last Name & Degree
George E Smith, MD
First Name & Middle Initial & Last Name & Degree
Amy E Harwood, PhD
First Name & Middle Initial & Last Name & Degree
Lee Ingle, PhD
First Name & Middle Initial & Last Name & Degree
Ian C Chetter, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31257120
Citation
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 2019 Jun 27.
Results Reference
result
PubMed Identifier
33186201
Citation
Pymer S, Ibeggazene S, Palmer J, Smith GE, Harwood AE, Carroll S, Ingle L, Chetter IC. Considering the Feasibility, Tolerability, and Safety of High-Intensity Interval Training as a Novel Treatment for Patients With Intermittent Claudication. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):188-193. doi: 10.1097/HCR.0000000000000551.
Results Reference
derived
PubMed Identifier
32636290
Citation
Pymer S, Harwood A, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, Long J, Rooms M, Chetter IC; INITIATE investigator group. High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study. BMJ Open. 2020 Jul 6;10(7):e038825. doi: 10.1136/bmjopen-2020-038825.
Results Reference
derived

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High Intensity Interval Training In pATiEnts With Intermittent Claudication

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