Clinical trial NCT05015543: Physical Training in Glioblastoma Patients During Cytotoxic Therapy
Official title: Glioblastoma and Sports - Does a Personal Training Program Improve Physical Performance and Quality of Life of Brain Tumor Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Keywords: sports
Glioblastoma (GBM)
physical training
Quality of Life (QOL)
Neuro-Oncology
Psycho-Oncology
fitness
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Increase in Physical Performance according to Physical Work Capacity (PWC) Test
timeFrame: Between week 0 and 16.
Secondary outcomes:
measure: Physical Work Capacity (PWC)
timeFrame: Between week 0 and 16 (and 24).
measure: PWC
timeFrame: after 8, 16 and 24 weeks
measure: Spiroergometry - maximal oxygen consumption (VO2max)
timeFrame: Between week 0 and 16 (and 24).
measure: Spiroergometry - lactate
timeFrame: Between week 0 and 16 (and 24).
measure: EORTC-QLQ-C30 Brain module
timeFrame: Between week 0 and 16 (and 24).
measure: Distress Thermometer (DT)
timeFrame: Between week 0 and 16 (and 24).
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Between week 0 and 16 (and 24).
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
Study officials:
affiliation: Universitätsklinikum Münster
name: Dorothee Wiewrodt, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: