Elastic band resistance training versus whole-body electrical muscle stimulation for people with cancer.
Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs in Patients With the Diagnosis of Malignant Diseases
NA · University of Erlangen-Nürnberg Medical School · NCT04067167
We will test whether 12 weeks of elastic band resistance exercises or whole-body electrical muscle stimulation help people with cancer keep or gain muscle, improve fitness, and feel less fatigued.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School (other) |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT04067167 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study compares a 12-week supervised elastic band resistance program to several whole-body electromyostimulation (WB-EMS) exercise regimens, including a sham WB-EMS and a free WB-EMS format. Participants are adults with solid or hematologic malignancies who are receiving curative or palliative anti-cancer therapy and have ECOG performance status 0–2. Primary outcomes include muscle strength and body composition (muscle mass), with additional measures of cardiorespiratory fitness, inflammatory markers, and patient-reported outcomes such as quality of life, fatigue, and performance status. Intervention sessions and outcome assessments take place at the University of Erlangen-Nürnberg Hector-Center over the 12-week period.
Who should consider this trial
Good fit: Adults with solid or hematologic malignancies undergoing curative or palliative anti-cancer therapy with ECOG status 0–2 and without contraindications listed in the protocol are the intended participants.
Not a fit: Patients with high fracture-risk bone metastases, significant cardiovascular disease, epilepsy, active skin lesions at electrode sites, implanted active metallic devices, pregnancy, or acute vein thrombosis are excluded and unlikely to benefit from these exercise interventions.
Why it matters
Potential benefit: If successful, the program could help patients with cancer preserve or increase muscle mass and strength, improve physical fitness, and reduce fatigue during anti-cancer treatment.
How similar studies have performed: Resistance exercise has shown benefits for maintaining muscle and function in people with cancer, while whole-body EMS is less well established and remains relatively novel in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma, lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation * ongoing or planned curative or palliative anti-cancer therapy * ECOG-Status 0-2 Exclusion Criteria: * simultaneous participation in other nutritional or exercise intervention Trials * bone metastases with high fracture risk * cardiovascular disease * use of anabolic medications * epilepsy * severe neurological or rheumatic diseases * skin lesions in the area of electrodes * energy active metals in body * pregnancy * acute vein thrombosis
Where this trial is running
Erlangen
- Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports — Erlangen, Germany (RECRUITING)
Study contacts
- Principal investigator: Dejan Reljic, Dr. — University Erlangen Nuremberg Medical School
- Study coordinator: Hans Joachim Herrmann, Dr.
- Email: hans.herrmann@uk-erlangen.de
- Phone: +49 9131 8545218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Cancer Cachexia, Inflammation, Muscular Atrophy, Cachexia, Muscular strength, Resistance training, Body composition