Physical Training in Glioblastoma Patients During Cytotoxic Therapy

Study Overview
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Brief Summary
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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 improves physical fitness increases quality of life/life satisfaction throughout the intervention 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
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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.

Official Title
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Glioblastoma and Sports - Does a Personal Training Program Improve Physical Performance and Quality of Life of Brain Tumor Patients

Conditions
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Glioblastoma

Intervention / Treatment
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* Other: Personal Training Program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients paticipating in the Personal Training Program<br>The study patients complete two training sessions per week (60 minutes each) under supervision (16 weeks) | Other: Personal Training Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Work Capacity (PWC) | 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) | Between week 0 and 16 (and 24). | 
| PWC | changes over time, follow-up | after 8, 16 and 24 weeks | 
| Spiroergometry - maximal oxygen consumption (VO2max) | Changes in the maximal oxygen consumption (measured during spiroergometry) | Between week 0 and 16 (and 24). | 
| Spiroergometry - lactate | Changes in the individual anaerobic lactate threshold (measured during spiroergometry) | Between week 0 and 16 (and 24). | 
| EORTC-QLQ-C30 Brain module | 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. | Between week 0 and 16 (and 24). | 
| Distress Thermometer (DT) | 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. | Between week 0 and 16 (and 24). | 
| Hospital Anxiety and Depression Scale (HADS) | 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. | Between week 0 and 16 (and 24). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sports, Glioblastoma (GBM), physical training, Quality of Life (QOL), Neuro-Oncology, Psycho-Oncology, fitness