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Physical Training in Glioblastoma Patients During Cytotoxic Therapy (MMH)

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Personal Training Program
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glioblastoma focused on measuring sports, Glioblastoma (GBM), physical training, Quality of Life (QOL), Neuro-Oncology, Psycho-Oncology, fitness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Universitätsklinikum MünsterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients paticipating in the Personal Training Program

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
PWC
changes over time, follow-up
Spiroergometry - maximal oxygen consumption (VO2max)
Changes in the maximal oxygen consumption (measured during spiroergometry)
Spiroergometry - lactate
Changes in the individual anaerobic lactate threshold (measured during spiroergometry)
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.
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.
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.

Full Information

First Posted
June 23, 2021
Last Updated
November 4, 2022
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT05015543
Brief Title
Physical Training in Glioblastoma Patients During Cytotoxic Therapy
Acronym
MMH
Official Title
Glioblastoma and Sports - Does a Personal Training Program Improve Physical Performance and Quality of Life of Brain Tumor Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 improves physical fitness increases quality of life/life satisfaction throughout the intervention 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
sports, Glioblastoma (GBM), physical training, Quality of Life (QOL), Neuro-Oncology, Psycho-Oncology, fitness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients paticipating in the Personal Training Program
Arm Type
Experimental
Arm Description
The study patients complete two training sessions per week (60 minutes each) under supervision (16 weeks)
Intervention Type
Other
Intervention Name(s)
Personal Training Program
Intervention Description
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 Outcome Measure Information:
Title
Increase in Physical Performance according to Physical Work Capacity (PWC) Test
Description
Evidence of a significant increase (at least 15%) in physical work [watt/kilogram bodyweight] at PWC75% of maximum heart rate.
Time Frame
Between week 0 and 16.
Secondary Outcome Measure Information:
Title
Physical Work Capacity (PWC)
Description
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)
Time Frame
Between week 0 and 16 (and 24).
Title
PWC
Description
changes over time, follow-up
Time Frame
after 8, 16 and 24 weeks
Title
Spiroergometry - maximal oxygen consumption (VO2max)
Description
Changes in the maximal oxygen consumption (measured during spiroergometry)
Time Frame
Between week 0 and 16 (and 24).
Title
Spiroergometry - lactate
Description
Changes in the individual anaerobic lactate threshold (measured during spiroergometry)
Time Frame
Between week 0 and 16 (and 24).
Title
EORTC-QLQ-C30 Brain module
Description
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.
Time Frame
Between week 0 and 16 (and 24).
Title
Distress Thermometer (DT)
Description
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.
Time Frame
Between week 0 and 16 (and 24).
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Between week 0 and 16 (and 24).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorothee Wiewrodt, PD Dr. med.
Phone
+49 251 83 48305
Email
dorothee.wiewrodt@ukmuenster.de
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Jost, M.Ed.
Email
johanna.jost@ukmuenster.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorothee Wiewrodt, PD Dr. med.
Organizational Affiliation
Universitätsklinikum Münster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Münster
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothee Wiewrodt, PD Dr. med.
Phone
+492518348305
Email
dorothee.wiewrodt@ukmuenster.de
First Name & Middle Initial & Last Name & Degree
Johanna Jost, M.Ed.
Email
johanna.jost@ukmuenster.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Training in Glioblastoma Patients During Cytotoxic Therapy

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