Clinical trial NCT04067167: Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases
Official title: Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs in Patients With the Diagnosis of Malignant Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Cancer Cachexia
Inflammation
Muscular Atrophy
Keywords: Cancer
Cachexia
Muscular strength
Resistance training
Body composition
Muscle mass
Physical exercise
Nutrition
whole-body electromyostimulation
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment parallel-group, randomized-controlled study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of a 12-week flexi band resistance training program compared to different whole-body electromyostimulation (WB-EMS) exercise programs on muscle strength, body composition (in particular muscle mass), cardiorespiratory fitness, inflammation, and patient-reported subjective outcomes (e.g. quality of life, fatigue, performance status) in patients with malignant disease undergoing curative or palliative anti-cancer treatment.


Eligibility 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

Primary outcomes:
measure: Muscle strength
timeFrame: 12 weeks
Secondary outcomes:
measure: Muscle Mass
timeFrame: 12 weeks
measure: Fat Mass
timeFrame: 12 weeks
measure: Total Body Water
timeFrame: 12 weeks
measure: Cardiorespiratory Fitness (CRF)
timeFrame: 12 weeks
measure: Inflammation status
timeFrame: 12 weeks
measure: Patient-reported performance status-1
timeFrame: 12 weeks
measure: Patient-reported performance status-2
timeFrame: 12 weeks
measure: Patient-reported Quality of Life (QoL)
timeFrame: 12 weeks
measure: Patient-reported Fatigue
timeFrame: 12 weeks
measure: Patient-reported Physical Activity
timeFrame: 12 weeks
measure: Objective Physical Activity
timeFrame: 12 weeks
measure: Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
Study officials:
affiliation: University Erlangen Nuremberg Medical School
name: Dejan Reljic, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Erlangen Nuremberg Medical School
name: Yurdagül Zopf, Prof.
role: PRINCIPAL_INVESTIGATOR
References: