Clinical trial NCT04784962: NMES for Rehab After Surgery
Official title: Neuromuscular Stimulation for Rehabilitation After General and Vascular Surgery - a Pilot Randomised Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Vascular Diseases
Keywords: rehabilitation
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised pilot study assessing the acceptability and feasibility of utilising neuromuscular stimulation devices to enhance post-operative rehabilitation and recovery after general, vascular and urological surgery procedures.

Detailed description: Patients undergoing inpatient rehabilitation after general, vascular or urological surgery will be invited to take part in a randomised study utilising either sham or active neuromuscular stimulation devices to enhance post-operative rehabilitation and physiotherapy.

Eligibility criteria: Inclusion Criteria

* Medically stable after index surgery
* Willing and able to participate in study protocol
* All ethnic groups, male or female above the age of 18 years
* Baseline Rockwood Frailty Score of 3 or greater

Exclusion Criteria

* Inability or unwillingness to participate in trial
* Implanted electrical device such as Pacemaker or defibrillator.
* Pregnant
* Acute deep vein thrombosis
* Previous use of NMES device

Primary outcomes:
measure: Safety and Acceptability of NMES as an adjunct for rehabilitation
timeFrame: At discharge from hospital (completion of study) - up to 28 days
Secondary outcomes:
measure: Time to return to baseline mobility and independence
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Generic Quality of life - SF-36
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Generic Quality of life - EQ-5D
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Generic Quality of life - EQ VAS
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Functional Independence Measure
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Barthel Index
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Rockwood Frailty Index
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Satisfaction with device
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Length of stay
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: 6 Minute Walk
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Timed Up and Go
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Compliance with device usage
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Q Frailty
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Time taken to achieve - Sitting for >5 minutes
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Standing for >1 minute
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Walking >50m
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Hospital Resource use
timeFrame: At discharge from hospital (completion of study) - up to 28 days
measure: Incremental cost-utility ratio, comparing NMES with standard care
timeFrame: At discharge from hospital (completion of study) - up to 28 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Alun H Davies, DM DSC FRCS
role: PRINCIPAL_INVESTIGATOR
References: