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Clinical Trials/NCT04043078
NCT04043078
Completed
N/A

Exercise In Critical Limb Ischaemia Patients Having Surgery

Hull University Teaching Hospitals NHS Trust1 site in 1 country25 target enrollmentAugust 3, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Critical Limb Ischemia
Sponsor
Hull University Teaching Hospitals NHS Trust
Enrollment
25
Locations
1
Primary Endpoint
Primary (Mortality)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 3, 2019
End Date
July 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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:-
  • 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

Outcomes

Primary Outcomes

Primary (Mortality)

Time Frame: 30 days

Mortality

Study Sites (1)

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