Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases
- Conditions
- CancerCancer CachexiaInflammationMuscular Atrophy
- Interventions
- Other: Free WB-EMSOther: Flexi band resistance trainingOther: WB-EMS (Sham-intervention)Other: WB-EMS
- Registration Number
- NCT04067167
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Free WB-EMS Free WB-EMS WB-EMS using a mobile System combined with nutritional therapy Flexi Band Resistance Training Flexi band resistance training Flexi band resistance Training combined with nutritional therapy WB-EMS (Sham-intervention) WB-EMS (Sham-intervention) Low-theshold WB-EMS combined with nutritional therapy WB-EMS WB-EMS WB-EMS combined with nutritional therapy
- Primary Outcome Measures
Name Time Method Muscle strength 12 weeks Muscle strength of the five major muscle groups (chest, upper back, lower back, abdominals, legs) will be assessed by using specific strength-training devices and estimated using the one Repetition Maximum (1-RM, the maximum amount of weight \[kg\] that can be lifted for one repetition)
- Secondary Outcome Measures
Name Time Method Muscle Mass 12 weeks Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Fat Mass 12 weeks Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Total Body Water 12 weeks Total body water (L) will be measured by Bioelectrical Impedance Analysis (BIA)
Cardiorespiratory Fitness (CRF) 12 weeks CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
Inflammation status 12 weeks Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP).
Patient-reported performance status-1 12 weeks Patient-reported performance Status will be assessed using the ECOG Performance Status questionnaire. It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. The score ranges from 0-5 (lower values = better outcome).
Patient-reported performance status-2 12 weeks Patient-reported performance status-2 will be assessed using the Karnofsky index. It is used methods to assess the functional status of a Patient. The score ranges from 0-100 (higher value = better outcome).
Patient-reported Quality of Life (QoL) 12 weeks Patient-reported QoL will be assessed using the EORTC QLQ-C30 questionnaire. It contains 30 questions (items), representing various aspects/dimensions of QoL (physical, role, emotional, cognitive and social), and 3 symptom scales (fatigue, pain and nausea).The scales of the different dimensions of QoL (higher values = better outcome) and symptoms (lower values = better outcomes) range from 0-100.
Patient-reported Fatigue 12 weeks Fatigue will be assessed using the FACIT-Fatigue scale. It contains 13 items (different aspects/dimensions of fatigue) each assessed on a scale of 0-4, with lower values indicating a better outcome).
Objective Physical Activity 12 weeks Obejective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
Patient-reported Physical Activity 12 weeks Patient-reported Physical Activity (PA) will be assessed using the the International Physical Activity Questionnaire (IPAQ). IPAQ records 4 aspects of PA (job-, transportation-, housework-, and leisure-time-related). There are two forms of output from scoring the IPAQ. Results can be reported in categories (low, moderate or high PA levels) or as a continuous variable (MET minutes a week, 1 MET = resting energy expenditure). MET minutes represent the amount of energy expended carrying out physical activity. High PA = at least 1500 MET minutes/week; moderate PA: at least 600 MET minutes/week; low PA: \< 600 MET minutes/week. Higher values represent a better outcome.
Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS) 12 weeks MetS will be calculated MetS-Z-Score will be calculated from each individual's measures of waist circumference (cm), mean arterial blood pressure (mmHg), blood levels of glucose (mg/dL), triglycerides (mg/dL), and HDL-cholesterol (mg/dL), based on equations specific to sex.
Trial Locations
- Locations (1)
Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
🇩🇪Erlangen, Germany