Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept

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.

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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 outcomes

Primary (Mortality)

Time frame: 30 days

Mortality

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

Exercise In Critical Limb Ischaemia Patients Having Surgery

Acronym: EXERCISE

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Aug 2, 2019
Registry last updated: Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed