Exercise In Critical Limb Ischaemia Patients having Surgery V1.0
Research type
Research Study
Full title
Inpatient Exercise for Critical Limb Ischaemia Patients Pre and Post Major Surgery: A Proof of Concept Study (EXERCISE)
IRAS ID
245426
Contact name
Joanne Palmer
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 30 days
Research 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. \n\nAround 50% of CLI patients present as an emergency, meaning training before admission is not feasible, so we propose to see if training during the hospital stay will aid a better recovery. However, as this has not been done in vascular surgical patients we need 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. \n\nThe 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. We will assess safety by recording adverse events and acceptability by adherence to exercise programme and qualitative interviews. We will evaluate processes and completeness of data collection and describe before and after measures of physical fitness and quality of life where this information will inform a pilot/definitive trial in the future.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0101
Date of REC Opinion
3 Jun 2019
REC opinion
Favourable Opinion