Physical Training in Glioblastoma Patients During Cytotoxic Therapy (MMH)

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

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma
• Intervention / Treatment: Other: Personal Training Program

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Universitatsklinikum Munster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Dorothee Wiewrodt, PD Dr. med., Universitatsklinikum Munster

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): October 17, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: sports; fitness; physical training; Glioblastoma (GBM); Psycho-Oncology; Quality of Life (QOL); Neuro-Oncology
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: MMH_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No