NCT04043078

Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept

Exercise In Critical Limb Ischaemia Patients Having Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hull University Teaching Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
OTHER	Exercise	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.

Timeline

• Start date: 2019-08-03
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2019-08-02
• Last updated: 2020-08-31

Locations

1 site across 1 country: United Kingdom