Surgery, Vascular Diseases
Conditions
Keywords
rehabilitation
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.
Interventions
DEVICERevitive Medic Neuromuscular Stimulation Device
Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).
DEVICERevitive Medic Neuromuscular Stimulation Device (Sham)
Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Sham and active devices are identical and will be randomly allocated
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Acceptability of NMES as an adjunct for rehabilitation | At discharge from hospital (completion of study) - up to 28 days | Qualitiative assessment of participant satisfaction and acceptance of NMES device as an adjunct to standard rehabilitation via semi-structured interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generic Quality of life - SF-36 | At discharge from hospital (completion of study) - up to 28 days | Generic quality of life values at entry and exit of study utilising the Short Form 36 health profile |
| Generic Quality of life - EQ-5D | At discharge from hospital (completion of study) - up to 28 days | Generic quality of life values at entry and exit of study utilising the EuroQol 5 Domain (EQ-5D) Health Metric |
| Generic Quality of life - EQ VAS | At discharge from hospital (completion of study) - up to 28 days | Generic quality of life values at entry and exit of study utilising the EuroQol Visual Analogue Scale |
| Functional Independence Measure | At discharge from hospital (completion of study) - up to 28 days | Scoring tool of ability to function independently at entry and exit of study |
| Barthel Index | At discharge from hospital (completion of study) - up to 28 days | Scoring tool of independence at entry and exit of study |
| Rockwood Frailty Index | At discharge from hospital (completion of study) - up to 28 days | Frailty index scoring tool at entry and exit of study |
| Satisfaction with device | At discharge from hospital (completion of study) - up to 28 days | User satisfaction with NMES device assessed by qualitative feedback and assessment |
| Length of stay | At discharge from hospital (completion of study) - up to 28 days | Hospital Length of stay |
| Time to return to baseline mobility and independence | At discharge from hospital (completion of study) - up to 28 days | Time in days to return to pre-operative mobility and independence |
| Timed Up and Go | At discharge from hospital (completion of study) - up to 28 days | Time taken to stand and walk from sitting in a chair at entry and exit of study |
| Compliance with device usage | At discharge from hospital (completion of study) - up to 28 days | User compliance with NMES device as assessed with usage diary and qualitative feedback |
| Q Frailty | At discharge from hospital (completion of study) - up to 28 days | Frailty assessment scale at entry and exit of study |
| Time taken to achieve - Sitting for >5 minutes | At discharge from hospital (completion of study) - up to 28 days | Mobility Milestone |
| Standing for >1 minute | At discharge from hospital (completion of study) - up to 28 days | Mobility Milestone |
| Walking >50m | At discharge from hospital (completion of study) - up to 28 days | Mobility Milestone |
| Hospital Resource use | At discharge from hospital (completion of study) - up to 28 days | Contacts with rehabilitation professionals during the using of NMES |
| Incremental cost-utility ratio, comparing NMES with standard care | At discharge from hospital (completion of study) - up to 28 days | Cost-effectiveness analysis |
| 6 Minute Walk | At discharge from hospital (completion of study) - up to 28 days | Distance walked in 6 minutes at entry and exit of study |
Countries
United Kingdom
Outcome results
None listed