GlioblastomaMMHNCT05015543
Physical Training in Glioblastoma Patients During Cytotoxic Therapy
A study testing Personal Training Program in people with Glioblastoma, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Personal Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jul 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed glioblastoma
- Karnofsky Index ≥ 70
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- ≥ 18 years
- Completed surgical therapy
- Completed radiation and chemotherapy
Show all 10Show fewer
- Thrombocytes > 50.000/µl
- Hb > 8 mg/dl
- Ability to give consent
- Mother tongue German/very good German skills
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
About this study
Official title: 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
Read more
- 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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- Personal Training Program
- Keywords
- sports, Glioblastoma (GBM), physical training, Quality of Life (QOL), Neuro-Oncology, Psycho-Oncology, fitness
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Training ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients paticipating in the Personal Training Program | Experimental | The study patients complete two training sessions per week (60 minutes each) under supervision (16 weeks) Receives: Other: Personal Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between week 0 and 16.
Secondary outcomes (7)
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)
Measured: Between week 0 and 16 (and 24).
PWC
changes over time, follow-up
Measured: after 8, 16 and 24 weeks
Spiroergometry - maximal oxygen consumption (VO2max)
Changes in the maximal oxygen consumption (measured during spiroergometry)
Measured: Between week 0 and 16 (and 24).
Spiroergometry - lactate
Changes in the individual anaerobic lactate threshold (measured during spiroergometry)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between week 0 and 16 (and 24).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start23 Jul 2020
- Primary completion17 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothee Wiewrodt, PD Dr. med., Principal investigator, Universitätsklinikum Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015543
- Sponsor's protocol ID
- MMH_01
- Acronym
- MMH
- Status last verified
- Dec 2024
- First submitted
- 23 Jun 2021
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glioblastoma and Sports - Does a Personal Training Program Improve Physical Performance and Quality of Life of Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT05015543
- Acronym / sponsor ID
- MMH / MMH_01
- Conditions
- Glioblastoma
- Keywords
- sports, Glioblastoma (GBM), physical training, Quality of Life (QOL), Neuro-Oncology, Psycho-Oncology, fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients paticipating in the Personal Training Program | Experimental | Other: Personal Training ProgramThe study patients complete two training sessions per week (60 minutes each) under supervision (16 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Newly diagnosed glioblastoma
- Karnofsky Index ≥ 70
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- ≥ 18 years
- Completed surgical therapy
Key exclusion criteria (7 listed)
- Diagnosed dementia (Mini-Mental-State-Test < 24/30 points)
- Pain (strong, permanent, restricting movement)
- Impairment of consciousness
- Fever
- Acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal Training ProgramOne 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. | Other | Patients paticipating in the Personal Training Program |
Primary outcome
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.
7 secondary outcomes
Physical Work Capacity (PWC)
Time frame: Between week 0 and 16 (and 24).
PWC
Time frame: after 8, 16 and 24 weeks
Spiroergometry - maximal oxygen consumption (VO2max)
Time frame: Between week 0 and 16 (and 24).
Spiroergometry - lactate
Time frame: Between week 0 and 16 (and 24).
EORTC-QLQ-C30 Brain module
Time frame: Between week 0 and 16 (and 24).
Distress Thermometer (DT)
Time frame: Between week 0 and 16 (and 24).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Between week 0 and 16 (and 24).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothee Wiewrodt, PD Dr. med. principal investigator
Universitätsklinikum Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Training Program in people with Glioblastoma, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Physical Performance according to Physical Work Capacity (PWC) Test (time frame: Between week 0 and 16.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.