Study protocol for neuromuscular stimulation for rehabilitation after general and vascular surgery: a pilot randomised clinical study. Issue 2 (16th February 2023)

• Record Type: Journal Article
• Authors: Nimura, Megumi; Lane, Tristan; Rawashdeh, Majd; Onida, Sarah; Javed, Azfar; Sritharan, Ganan; Reese, George; Hrouda, David; Davies, A H
• Is Part Of: BMJ open. Volume 13:Issue 2(2023)
• Publication Date: 2023-02-16
• Subjects: vascular surgery -- rehabilitation medicine -- colorectal surgery -- urology; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2022-061800
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Objectives: To investigate the acceptability and safety of neuromuscular stimulation (NMES) as an adjunct for rehabilitation after vascular and general surgery. Methods and analysis: Prospective, single-centre, single-blind, parallel group, randomised controlled study. This study will be conducted in a single-centre, secondary care setting (National Healthcare Service Hospital) in the UK. All patients aged over 18 years undergoing vascular or general surgery with Rockwood Frailty Score of 3 or above on admission. Exclusion is inability or unwillingness to participate in trial, implanted electrical device, pregnancy and acute deep vein thrombosis. Target number of recruitment is 100. Participants will be randomly assigned to active NMES group (group A) or placebo NMES group (group B) prior to surgery. Participants will be blinded and asked to use the NMES device, 1–6 sessions daily (30 min per session) after surgery in addition to standard National Health Service rehabilitation care until discharge. The primary study outcomes are acceptability and safety of NMES assessed by the device satisfaction questionnaire on discharge and adverse events recorded during hospital stay. The secondary outcomes are the postoperative recovery and cost-effectiveness compared between two groups, assessed by various activity tests, mobility and independence measures and questionnaires. Ethics and dissemination: Ethical approvals were provided by London-Harrow Research Ethics Committee (REC) and the Health Research Authority (HRA), Ref: 21/PR/0250. Findings will be published in a peer-reviewed journal and presented at national and international conferences. Trial registration number: NCT04784962 .