High Intensity Interval Training In pATiEnts With Intermittent Claudication

NCT04042311 | Completed Results

• 1 other identifier: R2219
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 high-intensity interval training (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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Keywords

Exercise; High-intensity interval training; interval training

Outcome Measures

Primary Outcomes (5)

• Tolerability Test - Related Withdrawals

  Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).

  From the first to last exercise session, i.e. from week 0 to week 6.

• 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 completion/withdrawal of the last patient

• Tolerability Test - Achieving the Required Intensity

  Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session

  From the first to last exercise session, i.e. from week 0 to week 6.

• Tolerability Test - Number of Sessions Completed

  Considers the number of sessions completed compared to the theoretical number.

  From the first to last exercise session, i.e. from week 0 to week 6.

• Tolerability Test - Number of HIIT Intervals Completed

  Considers the number of HIIT intervals completed compared to the theoretical number.

  From the first to last exercise session, i.e. from week 0 to week 6.

Secondary Outcomes (12)

• Safety Events Recorded

  From enrolment to completion of 12-week follow-up

• Acceptability Testing

  post-intervention follow-up, i.e. week 6.

• Maximum Walking Distance

  Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

• Peak Oxygen Uptake

  Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.

• Quality of Life Questionnaire Short-form-36 (SF-36)

  Baseline and post-intervention (week 6)

Study Arms (1)

High-Intensity interval training (workstream 1)

EXPERIMENTAL

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

Interventions

High-intensity interval training OTHER

a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike.

High-Intensity interval training (workstream 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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:
• 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
• Unable to provide informed consent

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower Block

Hull, HU3 2JZ, United Kingdom

Location

Related Publications (4)

• Pymer S, Harwood AE, Ibeggazene S, McGregor G, Huang C, Nicholls AR, Ingle L, Long J, Rooms M, Chetter IC, Twiddy M. High INtensity Interval Training in pATiEnts with Intermittent Claudication: A Qualitative Acceptability Study. Ann Vasc Surg. 2024 May;102:17-24. doi: 10.1016/j.avsg.2023.11.043. Epub 2024 Jan 30.

  PMID: 38301846 RESULT

• Pymer S, Harwood AE, Prosser J, Waddell A, Rhavindhran B, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, He H, Long J, Rooms M, Chetter IC. High-intensity interval training in patients with intermittent claudication. J Vasc Surg. 2023 Oct;78(4):1048-1056.e4. doi: 10.1016/j.jvs.2023.05.045. Epub 2023 Jun 16.

  PMID: 37330704 RESULT

• 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.

  PMID: 33186201 DERIVED

• 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.

  PMID: 32636290 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr Sean Pymer
• Organization: Hull University Teaching Hospitals NHS Trust

s.pymer@nhs.net

01482 674643

Study Officials

• Sean Pymer, MSc

  Academic Vascular Surgical Unit, Hull York Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: August 1, 2019
• Study Start: June 15, 2018
• Primary Completion: April 4, 2022
• Study Completion: July 4, 2022
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)