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Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients

ConditionsOesophageal CancerGastric CancerDuodenal CancerColorectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cologne

About this trial

The purpose of this study is to assess the efficacy of modulated mid-frequency whole-body electromyostimulation (WB-EMS) combined with nutritional therapy in patients with gastrointestinal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with oesophageal, gastric, duodenal, colon or rectal cancer following surgery without further therapy and with neoadjuvant and adjuvant therapy

medical clearance for exercise training

written declaration of consent from the study participant

Disqualifiers

Participation in another study on the topic of exercise or nutrition

Electronic implants such as pacemakers, pumps, and coronary stents

Cardiac arrhythmia

Implants in the area of application (e.g. breast implants)

Trial design

Design model

Parallel

Treatments tested in this trial

  • mid-frequency whole-body electromyostimulation (WB-EMS)

    Other intervention

    supervised group training sessions at least once and optionally twice a week, lasting 11-20 minutes, over 12 weeks, 12-24 training sessions in total

  • conventional exercise training

    Other intervention

    supervised group training at least once a week, optional additional home-based training once a week, lasting 40 minutes, over 12 weeks, 12-24 training sessions in total

  • nutritional therapy

    Other intervention

    conventional nutritional counselling with guidelines and digital nutritional coaching

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: WB-EMSExperimental treatment 2 interventions
Group B: CONTROLActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Muscle mass of the quadriceps muscle

Muscle mass of the quadriceps muscle (vastus lateralis / rectus femoris), cross-sectional diameter (CSD) using ultrasound. Muscle ultrasound represents a cheap and user-friendly, yet robust and reliable, method to monitor muscle mass.

Time frame
Baseline and week 12

Secondary outcomes

1

Body composition

Body composition including skeletal muscle mass, fat free mass, fat mass, total body water, body cell mass and extracellular mass, using bioimpedance analysis (BIA) (Nutriguard-MS)

Time frame
Baseline and week 12
2

Performance Status

Performance Status, with the help of Karnofsky Index (range 0 - 100, higher = better)

Time frame
Baseline and week 12
3

Endurance capacity

Endurance capacity, using spiroergometry measuring maximal oxygen uptake (VO2 max) (higher = better)

Time frame
Baseline and week 12
4

Lower limb performance

Lower limb performance, using 1 minute sit-to-stand test (higher = better)

Time frame
Baseline and week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cologne

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: