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Trial record 4 of 47693 for:    intensity

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042311
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
University of Hull
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Intermittent Claudication Other: High-intensity interval training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : September 28, 2021
Estimated Study Completion Date : December 28, 2021

Arm Intervention/treatment
Experimental: High-Intensity interval training
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
Other: High-intensity interval training
a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike.




Primary Outcome Measures :
  1. Safety Events Recorded [ Time Frame: From enrolment to completion of 12-week follow-up ]
    Defined as the occurrence of any adverse or serious adverse events.

  2. Tolerability Test [ Time Frame: From the first to last exercise session, i.e. from week 0 to week 6. ]
    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.

  3. Feasibility Test [ Time Frame: From study opening to recruitment to completion of last patient last visit i.e. 29 weeks ]
    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 :
  1. Acceptability testing [ Time Frame: 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.

  2. Maximum walking distance [ Time Frame: 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.

  3. Pain-free walking distance [ Time Frame: 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 experiencing claudication pain.

  4. Physiological parameters [ Time Frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. ]
    Physiological variables via cardiopulmonary exercise test to assess peak oxygen uptake and ventilatory anaerobic threshold

  5. Quality of Life Questionnaire SF-36 [ Time Frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. ]
    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.

  6. Quality of Life Questionnaire - VascuQol [ Time Frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. ]
    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.

  7. Ankle-Brachial Pressure Index [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Workstream 1

Inclusion criteria:

  • Community dwelling adults aged 18 or over.
  • ABPI <0.9 at rest or a drop of more than 20mmHg after exercise testing
  • Ability to walk unaided
  • English speaking and able to comply with exercise instructions

Exclusion criteria:

  • Patients who are unable to provide informed consent
  • Critical limb ischaemia/rest pain
  • Active cancer treatment
  • Significant comorbidities precluding participation in exercise testing and/or training as per the American College of Sports Medicine Guidelines.

Resting/uncontrolled tachycardia (>100bpm) and/or Resting/uncontrolled hypertension (SBP >180mmHg or DBP >100mmHg)

• Symptomatic hypotension

Additional exclusion criteria:

Further to analysis of CPET results, patients will be prevented from continuing their involvement in the study if there is indication of:

  • Exercise-induced ischaemia or significant haemodynamic compromise.
  • An inability to complete a maximal effort CPET.

Workstream 2 - pending review of workstream 1 results.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042311


Contacts
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Contact: Sean Pymer, MSc 01482 674643 sean.pymer@hey.nhs.uk

Locations
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United Kingdom
Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower Block Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Sean Pymer, MSc         
Principal Investigator: Sean Pymer, MSc         
Sub-Investigator: George E Smith, MD         
Sub-Investigator: Amy E Harwood, PhD         
Sub-Investigator: Lee Ingle, PhD         
Sub-Investigator: Ian C Chetter, MD         
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
University of Hull
Investigators
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Principal Investigator: Sean Pymer, MSc Academic Vascular Surgical Unit, Hull York Medical School

Additional Information:
Publications of Results:
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Responsible Party: Hull University Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04042311    
Other Study ID Numbers: R2219
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hull University Teaching Hospitals NHS Trust:
Exercise
High-intensity interval training
interval training
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms