Sponsor:
University of Erlangen-Nürnberg Medical School, University of Erlangen-Nürnberg Medical School
Collaborator:
-
Studienleiter
Dejan Reljic, Dr. Principal Investigator University Erlangen Nuremberg Medical School Yurdagül Zopf, Prof. Principal Investigator University Erlangen Nuremberg Medical School
Kontakt
Hans Joachim Herrmann, Dr. Kontakt: Phone: +49 9131 8545218 E-Mail: hans.herrmann@uk-erlangen.de» Kontaktdaten anzeigen Yurdagül Zopf, Prof. Kontakt: Phone: +49 9131 8545218 E-Mail: yurdaguel.zopf@uk-erlangen.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports 91054 Erlangen (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Hans Joachim Herrmann, Dr. Phone: +49 9131 8545218 E-Mail: hans.herrmann@uk-erlangen.de
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
1. Overall physical fitness (Time Frame - 12 weeks): 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)
Secondary outcome:
1. Muscle mass (Time Frame - 12 weeks): Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
2. Fat mass (Time Frame - 12 weeks): Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
3. Total Body Water (Time Frame - 12 weeks): Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA)
4. Patient-reported performance status-1 (Time Frame - 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).
5. Patient-reported performance status-2 (Time Frame - 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).
6. Patient-reported Quality of Life (QoL) (Time Frame - 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.
7. Patient-reported Fatigue (Time Frame - 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).
8. Patient-reported Physical Activity (Time Frame - 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.
9. Objective Physical Activity (Time Frame - 12 weeks): Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
10. Inflammatory blood markers (Time Frame - 12 weeks): Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity creactive protein (hs-CRP).
11. Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS) (Time Frame - 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.
Experimental: High-intensity interval training (HIIT) Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT)
Experimental: Combined HIIT and Resistance Training (Combi) Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and resistance training
Resistance Training: 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
WB-EMS: 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
High-intensity interval training (HIIT): 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
Combined HIIT and Resistance Training (Combi): 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
Quelle: ClinicalTrials.gov
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"Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy"
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