Glioblastoma
Conditions
Keywords
sports, Glioblastoma (GBM), physical training, Quality of Life (QOL), Neuro-Oncology, Psycho-Oncology, fitness
Brief summary
The aim of the present study is the prospective controlled use of physical activity in a collective of patients with glioblastoma after surgery and concomitant radiation/chemotherapy and during adjuvant cytotoxic therapy. The research question is whether physical exercise is feasible and whether patients benefit physically and mentally from the activities performed. For this purpose, specific training units under the supervision of a certified trainer and sports scientist as well as standardized sports medical test procedures are implemented. Beyond the instructed training, general physical activity phases are recorded electronically using a pedometer/activity tracker, which is worn at all times. It will be examined whether the individual training program 1. improves physical fitness 2. increases quality of life/life satisfaction throughout the intervention 3. can be detected in blood due to increased concentrations of brain-derived neurotrophic factor 1 (BDNF-1) (voluntary) The measurements should be taken before and 8, 16 and 24 weeks after the start of training.
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.
Interventions
OTHERPersonal 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.
Sponsors
University Hospital Muenster
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in Physical Performance according to Physical Work Capacity (PWC) Test | 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
| Measure | Time frame | Description |
|---|---|---|
| PWC | after 8, 16 and 24 weeks | changes over time, follow-up |
| Spiroergometry - maximal oxygen consumption (VO2max) | Between week 0 and 16 (and 24). | Changes in the maximal oxygen consumption (measured during spiroergometry) |
| Spiroergometry - lactate | Between week 0 and 16 (and 24). | Changes in the individual anaerobic lactate threshold (measured during spiroergometry) |
| Physical Work Capacity (PWC) | 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) |
| Distress Thermometer (DT) | 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. |
| Hospital Anxiety and Depression Scale (HADS) | 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. |
| EORTC-QLQ-C30 Brain module | 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. |
Countries
Germany
Outcome results
None listed