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Completed

NCT Number: NCT04784962

NMES for Rehab After Surgery

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.

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Key information

Conditions

Surgery Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revitive Medic Neuromuscular Stimulation Device

Device

Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).

Revitive Medic Neuromuscular Stimulation Device (Sham)

Device

Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)

Primary outcomes

  1. Safety and Acceptability of NMES as an adjunct for rehabilitation

    Time frame: 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 outcomes

  1. Time to return to baseline mobility and independence

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Time in days to return to pre-operative mobility and independence

  2. Generic Quality of life - SF-36

    Time frame: 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

  3. Generic Quality of life - EQ-5D

    Time frame: 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

  4. Generic Quality of life - EQ VAS

    Time frame: 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

  5. Functional Independence Measure

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Scoring tool of ability to function independently at entry and exit of study

  6. Barthel Index

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Scoring tool of independence at entry and exit of study

  7. Rockwood Frailty Index

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Frailty index scoring tool at entry and exit of study

  8. Satisfaction with device

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    User satisfaction with NMES device assessed by qualitative feedback and assessment

  9. Length of stay

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Hospital Length of stay

  10. 6 Minute Walk

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Distance walked in 6 minutes at entry and exit of study

  11. Timed Up and Go

    Time frame: 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

  12. Compliance with device usage

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    User compliance with NMES device as assessed with usage diary and qualitative feedback

  13. Q Frailty

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Frailty assessment scale at entry and exit of study

  14. Time taken to achieve - Sitting for >5 minutes

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Mobility Milestone

  15. Standing for >1 minute

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Mobility Milestone

  16. Walking >50m

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Mobility Milestone

  17. Hospital Resource use

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Contacts with rehabilitation professionals during the using of NMES

  18. Incremental cost-utility ratio, comparing NMES with standard care

    Time frame: At discharge from hospital (completion of study) - up to 28 days

    Cost-effectiveness analysis

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Neuromuscular Stimulation for Rehabilitation After General and Vascular Surgery - a Pilot Randomised Clinical Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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