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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance Training (RT) | Experimental | Individualized, protein-rich nutritional therapy combined with resistance training |
|
| WB-EMS | Experimental | Individualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS) |
|
| High-intensity interval training (HIIT) | Experimental | Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT) |
|
| Combined HIIT and Resistance Training (Combi) | Experimental | Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and resistance training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance Training | Other | 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)
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall 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) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle mass | Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA) | 12 weeks |
| Fat mass | Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hans Joachim Herrmann, Dr. | Contact | +49 9131 8545218 | hans.herrmann@uk-erlangen.de | |
| Yurdagül Zopf, Prof. | Contact | +49 9131 8545218 | yurdaguel.zopf@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Dejan Reljic, Dr. | University Erlangen Nuremberg Medical School | Principal Investigator |
| Yurdagül Zopf, Prof. | University Erlangen Nuremberg Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports | Recruiting | Erlangen | 91054 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35868017 | Derived | Reljic D, Herrmann HJ, Jakobs B, Dieterich W, Mougiakakos D, Neurath MF, Zopf Y. Feasibility, Safety, and Preliminary Efficacy of Very Low-Volume Interval Training in Advanced Cancer Patients. Med Sci Sports Exerc. 2022 Nov 1;54(11):1817-1830. doi: 10.1249/MSS.0000000000002989. Epub 2022 Jul 8. |
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Parallel Assignment parallel-group, randomized-controlled study
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|
| WB-EMS | Other | 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:
|
|
| High-intensity interval training (HIIT) | Other | 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):
|
|
| Combined HIIT and Resistance Training (Combi) | Other | 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:
Resistance Training:
|
|
| 12 weeks |
| Total Body Water | Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA) | 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). | 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). | 12 weeks |
| Patient-reported Quality of Life (QoL) | 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. | 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). | 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. | 12 weeks |
| Objective Physical Activity | Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome. | 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). | 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. | 12 weeks |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007249 | Inflammation |
| D002100 | Cachexia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013851 | Thinness |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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