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JOURNAL ONKOLOGIE – STUDIE
MMH

Physical Training in Glioblastoma Patients During Cytotoxic Therapy

Rekrutierend

NCT-Nummer:
NCT05015543

Studienbeginn:
Juli 2020

Letztes Update:
07.11.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Glioblastoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Muenster

Collaborator:
-

Studienleiter

Dorothee Wiewrodt, PD Dr. med.
Principal Investigator
Universitätsklinikum Münster

Kontakt

Dorothee Wiewrodt, PD Dr. med.
Kontakt:
Phone: +49 251 83 48305
E-Mail: dorothee.wiewrodt@ukmuenster.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Dorothee Wiewrodt, PD Dr. med.
Phone: +492518348305
E-Mail: dorothee.wiewrodt@ukmuenster.de

Johanna Jost, M.Ed.
E-Mail: johanna.jost@ukmuenster.de
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

The personal trainers of the university clinics in Bochum and Homburg/Saar receive specific

training activities from Münster's trainer Ralf Brandt in order to ensure a standardized

concept. This way, a comparison of the trainings' conduction and recording is possible both

quantitatively and qualitatively.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Newly diagnosed glioblastoma

- Karnofsky Index ≥ 70

- Eastern Cooperative Oncology Group (ECOG) ≤ 2

- ≥ 18 years

- Completed surgical therapy

- Completed radiation and chemotherapy

- Thrombocytes > 50.000/µl

- Hb > 8 mg/dl

- Ability to give consent

- Mother tongue German/very good German skills

Exclusion Criteria:

- Diagnosed dementia (Mini-Mental-State-Test < 24/30 points)

- Pain (strong, permanent, restricting movement)

- Impairment of consciousness

- Fever

- Acute infection

- Pregnancy and lactation

- Insufficiently adjusted epilepsy (despite anticonvulsive therapy > 3 focal seizures

per day or > 1 generalized seizure in the previous 3 days)

Studien-Rationale

Primary outcome:

1. Increase in Physical Performance according to Physical Work Capacity (PWC) Test (Time Frame - Between week 0 and 16.):
Evidence of a significant increase (at least 15%) in physical work [watt/kilogram bodyweight] at PWC75% of maximum heart rate.



Secondary outcome:

1. Physical Work Capacity (PWC) (Time Frame - Between week 0 and 16 (and 24).):
PWC stratified according to: age (<40, 40-60, >60 years) Karnofsky performance status (KPS) (70-80 vs. 90-100 %) Gender PWC test 130, 150, (170)

2. PWC (Time Frame - after 8, 16 and 24 weeks):
changes over time, follow-up

3. Spiroergometry - maximal oxygen consumption (VO2max) (Time Frame - Between week 0 and 16 (and 24).):
Changes in the maximal oxygen consumption (measured during spiroergometry)

4. Spiroergometry - lactate (Time Frame - Between week 0 and 16 (and 24).):
Changes in the individual anaerobic lactate threshold (measured during spiroergometry)

5. EORTC-QLQ-C30 Brain module (Time Frame - Between week 0 and 16 (and 24).):
Changes in Health Related Quality of Life (HRQoL) using a standardized questionnaire; The EORTC QLQ-C30 questionnaire contains 30 questions and assesses the quality of life of oncology patients multidimensionally across 10 subscales. Times of measurement in week 0, 4, 8, 16, 20 and 24.

6. Distress Thermometer (DT) (Time Frame - Between week 0 and 16 (and 24).):
Changes in Health Related Quality of Life (HRQoL) using a standardized questionnaire; scale from 1 (not stressed at all) to 10 (extremly stressed); Times of measurement in week 0, 4, 8, 16, 20 and 24.

7. Hospital Anxiety and Depression Scale (HADS) (Time Frame - Between week 0 and 16 (and 24).):
Changes in Health Related Quality of Life (HRQoL) using a standardized questionnaire; The Hospital Anxiety and Depression Scale (HADS) is a self-rating scale developed to assess psychological distress in non-psychiatric patients. It consists of two subscales, anxiety and depression (14 items); Times of measurement in week 0, 4, 8, 16, 20 and 24.

Geprüfte Regime

  • Personal Training Program:
    One training sessions includes an interval training on a bicycle ergometer. The second one is a strength training with exercise machines. Both trainings are supplemented by coordinative aspects.

Quelle: ClinicalTrials.gov


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