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Individualized, protein-rich nutritional therapy combined with resistance training

Individualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS)

Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT)

Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and 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

Resistance Training

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

WB-EMS

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

High-intensity interval training (HIIT)

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

Combined HIIT and Resistance Training (Combi)

Hans Joachim Herrmann, Dr.

Yurdagül Zopf, Prof.

Dejan Reljic, Dr.

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

Parallel Assignment parallel-group, randomized-controlled study

Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy

Effects of a Protein-rich Individualized Nutritional Therapy Combined With Different Time-efficient Exercise Programs on Physical Fitness, Inflammation and Muscle Status in Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment

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)

Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA)

Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA)

Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA)

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 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 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.

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).

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.

Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.

Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity creactive protein (hs-CRP).

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.

Spots Global Cancer Trial Database for protein intake