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JOURNAL ONKOLOGIE – STUDIE
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Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases

Rekrutierend

NCT-Nummer:
NCT04067167

Studienbeginn:
Mai 2019

Letztes Update:
26.08.2019

Wirkstoff:
-

Indikation (Clinical Trials):
Muscular Atrophy, Wasting Syndrome, Inflammation, Atrophy, Cachexia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

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

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

Dejan Reljic, Dr.
Phone: +49 9131 8545218
E-Mail: dejan.reljic@uk-erlangen.de
» Ansprechpartner anzeigen

Studien-Informationen

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.
 

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Studien-Rationale

Primary outcome:

1. Muscle strength (Time Frame - 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:

1. Muscle Mass (Time Frame - 12 weeks):
Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)

2. Fat Mass (Time Frame - 12 weeks):
Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)

3. Total Body Water (Time Frame - 12 weeks):
Total body water (L) will be measured by Bioelectrical Impedance Analysis (BIA)

4. Cardiorespiratory Fitness (CRF) (Time Frame - 12 weeks):
CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)

5. Inflammation status (Time Frame - 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).

6. 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).

7. 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).

8. 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.

9. 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).

10. 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.

11. Objective Physical Activity (Time Frame - 12 weeks):
Obejective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.

12. 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.

Studien-Arme

  • Sham Comparator: WB-EMS (Sham-intervention)
    Low-theshold WB-EMS combined with nutritional therapy
  • Experimental: WB-EMS
    WB-EMS combined with nutritional therapy
  • Experimental: Free WB-EMS
    WB-EMS using a mobile System combined with nutritional therapy
  • Experimental: Flexi Band Resistance Training
    Flexi band resistance Training combined with nutritional therapy

Geprüfte Regime

  • WB-EMS (Sham-intervention):
    Whole-Body Electromyostimulation (WB-EMS): WB-EMS with low-threshold stimulation during a study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight) 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:
    Whole-Body Electromyostimulation (WB-EMS): WB-EMS during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight) WB-EMS 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
  • Free WB-EMS:
    Whole-Body Electromyostimulation (WB-EMS) using a mobile system: WB-EMS during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight) WB-EMS 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
  • Flexi band resistance training:
    Flexi band resistance Training: Training during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight) patients perform resistance exercises using flexi bands flexi band exercises are conceptualized to activate similar muscle groups as EMS exercise time-effort per session: ~20 min 2 training sessions per week

Quelle: ClinicalTrials.gov


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