Physical Training in Glioblastoma Patients During Cytotoxic Therapy (MMH)

University Hospital Muenster

Status: Completed

Conditions: Glioblastoma

Treatments: Other: Personal Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05015543

MMH_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Patients paticipating in the Personal Training Program

Experimental group

Description:

The study patients complete two training sessions per week (60 minutes each) under supervision (16 weeks)

Treatment:

Other: Personal Training Program