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Physical Training in Glioblastoma Patients During Cytotoxic Therapy (MMH)

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ClinicalTrials.gov Identifier: NCT05015543
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

Study Description
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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.


Condition or disease Intervention/treatment Phase
Glioblastoma Other: Personal Training Program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Glioblastoma and Sports - Does a Personal Training Program Improve Physical Performance and Quality of Life of Brain Tumor Patients
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05015543


Contacts
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Contact: Dorothee Wiewrodt, PD Dr. med. +49 251 83 48305 dorothee.wiewrodt@ukmuenster.de
Contact: Johanna Jost, M.Ed. johanna.jost@ukmuenster.de

Locations
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Germany
Universitätsklinikum Münster Recruiting
Münster, Nordrhein-Westfalen, Germany, 48149
Contact: Dorothee Wiewrodt, PD Dr. med.    +492518348305    dorothee.wiewrodt@ukmuenster.de   
Contact: Johanna Jost, M.Ed.       johanna.jost@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Dorothee Wiewrodt, PD Dr. med. Universitätsklinikum Münster
More Information
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT05015543    
Other Study ID Numbers: MMH_01
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
sports
Glioblastoma (GBM)
physical training
Quality of Life (QOL)
 Neuro-Oncology
Psycho-Oncology
fitness
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue