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Completed

NCT Number: NCT02834338

Enhanced Perioperative Mobilization (EPM) Trial

Randomized Controlled Trial to monitor and increase the postoperative mobilization of the patients undergoing major visceral surgery by giving a continuous autofeedback of the step count using activity tracking wristbands.

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden

Dresden, 01309, Germany

About this study

Patients undergoing elective open and laparoscopic surgery of colon, rectum, stomach, pancreas and liver for any indication will be included. Further inclusion criteria are: age between 18-75 years, ASA score < 4, and a signed informed consent. Patients are stratified into two subgroups (laparoscopic and open surgery) and will be randomized 1:1 for an autofeedback of their step-count using an activity tracker wristband or for the control group without autofeedback. Sample size (n = 29 patients in each of the four groups, overall n = 119) is calculated on an assumed difference in step-count of 250 steps daily (intervention versus control group). The primary study endpoint is the step-count during the first five postoperative days; secondary endpoints are the percentage of patients in the two groups, who master the predefined mobilization (step-count) targets, the assessment of additional activity data from the devices, the assessment of the preoperative mobility, length of hospital and intensive care unit stay, number of patients who receive physiotherapy, 30-day mortality, and the overall 30-day morbidity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • elective laparoscopic and open surgery of the colon and rectum (colectomy, hemicolectomy, segment resection, rectum extirpation, deep anterior rectum resection, sigmoid resection, proctocolectomy), of the stomach (total, subtotal and atypical gastric resections), of the pancreas (any kind of pancreatic resections), and of the liver (hemihepatectomy, atypical resection, anatomical segment resection)
  • ASA score < IV
  • completed informed consent.

Exclusion criteria

  • emergency surgery
  • mental inability to complete postoperative assessment protocols
  • preoperatively immobile patients

Treatment and study plan

activity tracking for autofeedback

Device

The intervention group receives an unblinded wristband. The handling of the activity trackers is explained to the patients and a predefined mobilization end-point (step-count) for the first five PODs is targeted. The target step-count was set at the 85% quartile obtained from a previous pilot study. The patients are assessed and monitored two times daily between 9 and 11 o'clock AM and between 3 and 5 o'clock PM by a surgical fellow or a study nurse throughout their hospital stay for read-out of the step count, assurance of the proper use and functioning, and for communication of the autofeedback.

Primary outcomes

  1. Median Step count

    Time frame: First to fifth postoperative day

Secondary outcomes

  1. Percentage of patients, who master the predefined mobilization (step-count) targets

    Time frame: First to fifth postoperative day

  2. Distance (km)

    Time frame: First to fifth postoperative day

    Assessed by the activity tracker wristband

  3. Activity time (min.)

    Time frame: First to fifth postoperative day

    Assessed by the activity tracker wristband

  4. inactivity

    Time frame: First to fifth postoperative day

    Assessed by the activity tracker wristband

  5. calorie consumption (kcal)

    Time frame: First to fifth postoperative day

    Assessed by the activity tracker wristband

  6. Compliance

    Time frame: First to fifth postoperative day

    Compliance to wear the wrist band

  7. Assessment of the preoperative mobility

    Time frame: Preoperative

    Measured by International Physical Activity Questionnaire (IPAQ)

  8. Length of hospital stay

    Time frame: 30 days

  9. Length of ICU stay

    Time frame: 30 days

  10. Amount of patients which receive physiotherapy

    Time frame: First to fifth postoperative day

  11. Mortality

    Time frame: 30 days

  12. Overall morbidity

    Time frame: 30 days

    According the Clavien-Dindo classification

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Usage of Activity Tracking in Major Visceral Surgery - the Enhanced Perioperative Mobilization (EPM) Trial

Acronym: EPMIII

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2016
Registry last updated
Oct 20, 2017

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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