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Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept (EXERCISE)

Primary Purpose

Critical Limb Ischemia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Critical Limb Ischemia

Eligibility Criteria

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

Inclusion Criteria:

  1. 18 years old or over
  2. Willing to participate and able to give written informed consent
  3. Clinical diagnosis of critical limb ischaemia or Fontaine Class III-IV or Rutherford Class 4-6
  4. Admitted to the vascular surgical ward for lower limb surgery

Exclusion Criteria:

  1. Patients presenting who have diabetes are presenting with acute limb ischaemia with no history of PAD
  2. Cognitive Impairment as demonstrated by not being able to safely follow instructions.
  3. Unable to understand or read English
  4. Absolute contraindications to exercise including:-

    • Acute MI
    • Ongoing unstable angina
    • Uncontrolled cardiac arrhythmia with hemodynamic compromise
    • Active endocarditis
    • Symptomatic severe aortic stenosis
    • Decompensated heart failure
    • Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
    • Acute myocarditis or pericarditis
    • Acute aortic dissection
  5. Physical disability that precludes safe and adequate exercise as determined by the clinical team
  6. Contraindications to IMT including:-

    • A history of spontaneous pneumothrorax (ie not due to traumatic injury)
    • A pneumothorax due to traumatic injury that has not fully healed
    • A burst eardrum that has not fully healed or any other condition of the eardrum
    • Unstable asthma and abnormally low perception of dyspnoea

Sites / Locations

  • Hull University Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise

Arm Description

Exercise and respiratory muscle training before surgery

Outcomes

Primary Outcome Measures

Primary (Mortality)
Mortality

Secondary Outcome Measures

Full Information

First Posted
July 31, 2019
Last Updated
August 28, 2020
Sponsor
Hull University Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04043078
Brief Title
Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept
Acronym
EXERCISE
Official Title
Exercise In Critical Limb Ischaemia Patients Having Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 3, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

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

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
Patients with critical limb ischaemia (CLI) are at risk of losing their limb and/or life and therefore have no option but to undergo bypass or amputation surgery. This presents a major physical challenge to the body and patients with low fitness will struggle to overcome the effects of the surgical trauma. Currently there is a high risk of a poorer outcome for CLI patients than with most other surgical procedures, as demonstrated by high rates of complications (20-46%) and 30 day mortality (7.5-13.5%). Up to 30% of people will die within the first year. Exercise and respiratory muscle training, before surgery, has shown a reduction in complications in other surgical specialties. Around 50% of CLI patients present as an emergency, meaning training before admission is not feasible, so the Investigator proposes to see if training during the hospital stay will aid a better recovery. However, as this has not been done in vascular surgical patients the investigator needs to initially test if this intervention is possible in this patient group in an acute hospital setting.The aim of this proof of concept single cohort study is to assess whether an exercise intervention, started on hospital admission and continued post-surgery, for the duration of the hospital admission, is safe, acceptable, well tolerated and feasible to run in an acute ward setting. The exercise regime will include daily upper limb aerobic (hand bike) and inspiratory muscle training (POWERbreathe) and upper body strength training every second day until discharge. The Investigator will assess safety by recording adverse events and acceptability by adherence to exercise programme and qualitative interviews. The Investigator will evaluate processes and completeness of data collection and describe before and after measures of physical fitness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Other
Arm Description
Exercise and respiratory muscle training before surgery
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
The exercise regime will include daily upper limb aerobic (hand bike) and inspiratory muscle training (POWERbreathe) and upper body strength training every second day until discharge.
Primary Outcome Measure Information:
Title
Primary (Mortality)
Description
Mortality
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old or over Willing to participate and able to give written informed consent Clinical diagnosis of critical limb ischaemia or Fontaine Class III-IV or Rutherford Class 4-6 Admitted to the vascular surgical ward for lower limb surgery Exclusion Criteria: Patients presenting who have diabetes are presenting with acute limb ischaemia with no history of PAD Cognitive Impairment as demonstrated by not being able to safely follow instructions. Unable to understand or read English Absolute contraindications to exercise including:- Acute MI Ongoing unstable angina Uncontrolled cardiac arrhythmia with hemodynamic compromise Active endocarditis Symptomatic severe aortic stenosis Decompensated heart failure Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis Acute myocarditis or pericarditis Acute aortic dissection Physical disability that precludes safe and adequate exercise as determined by the clinical team Contraindications to IMT including:- A history of spontaneous pneumothrorax (ie not due to traumatic injury) A pneumothorax due to traumatic injury that has not fully healed A burst eardrum that has not fully healed or any other condition of the eardrum Unstable asthma and abnormally low perception of dyspnoea
Facility Information:
Facility Name
Hull University Teaching Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept

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