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
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
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
NCT ID
NCT05015543
First Posted
June 23, 2021
Last Updated
November 4, 2022
Sponsor
University Hospital Muenster
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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