This study aims to evaluate the effects of a 12-week protein-rich individualized nutritional therapy combined with different time-efficient exercise programs on overall physical fitness (cardiorespiratory fitness and muscular fitness), inflammation, and muscle mass/body composition in patients with malignant disease undergoing curative or palliative anti-cancer treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Conventional Resistance Training: Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a resistance training program consisting of five exercises: exercises (chest, upper/lower back, abdominals, legs) * 1 set per exercise * time-effort per session: \~20 min * 2 training sessions per week
Whole-Body Electromyostimulation (WB-EMS): Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with WB-EMS training: * Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; patients perform simple exercises during the stimulation period following a video tutorial * time-effort per session: \~20 min * 2 training sessions per week
Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
Erlangen, Germany
RECRUITINGOverall physical fitness
Cardiorespiratory Fitness and Muscular Fitness (Overall Fitness Score is calculated from Maximum Oxygen uptake, VO2max, and Muscle strength (estimated from the 1-repetition Maximum - the maximum amount of weight \[kg\] that can be lifted for one repetition) of the five major muscle groups (chest, upper back, lower back, abdominals, legs)
Time frame: 12 weeks
Muscle mass
Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
Time frame: 12 weeks
Fat mass
Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
Time frame: 12 weeks
Total Body Water
Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA)
Time frame: 12 weeks
Patient-reported performance status-1
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).
Time frame: 12 weeks
Patient-reported performance status-2
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).
Time frame: 12 weeks
Patient-reported Quality of Life (QoL)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HIIT: Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with high-intensity interval training (HIIT): * supervised cycle-ergometer training at at 80-95% HRmax * time-effort per session: \~15 min * 2 training sessions per week
HIIT combined with conventional Resistance Training: Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a combined HIIT and resistance training program: HIIT: * supervised cycle-ergometer training at at 80-95% HRmax * time-effort per session: \~15 min * 1 training session per week Resistance Training: * five exercises: exercises (chest, upper/lower back, abdominals, legs) * 1 set per exercise * time-effort per session: \~20 min * 1 training session per week
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.
Time frame: 12 weeks
Patient-reported Fatigue
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).
Time frame: 12 weeks
Patient-reported Physical Activity
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.
Time frame: 12 weeks
Objective Physical Activity
Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
Time frame: 12 weeks
Inflammatory blood markers
Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity creactive protein (hs-CRP).
Time frame: 12 weeks
Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)
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.
Time frame: 12 weeks