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Completed

NCT Number: NCT05015543

Physical Training in Glioblastoma Patients During Cytotoxic Therapy

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Personal Training Program

Other

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.

Primary outcomes

  1. Increase in Physical Performance according to Physical Work Capacity (PWC) Test

    Time frame: 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 outcomes

  1. Physical Work Capacity (PWC)

    Time frame: 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)

  2. PWC

    Time frame: after 8, 16 and 24 weeks

    changes over time, follow-up

  3. Spiroergometry - maximal oxygen consumption (VO2max)

    Time frame: Between week 0 and 16 (and 24).

    Changes in the maximal oxygen consumption (measured during spiroergometry)

  4. Spiroergometry - lactate

    Time frame: Between week 0 and 16 (and 24).

    Changes in the individual anaerobic lactate threshold (measured during spiroergometry)

  5. EORTC-QLQ-C30 Brain module

    Time frame: 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.

  6. Distress Thermometer (DT)

    Time frame: 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.

  7. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Acronym: MMH

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2021
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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