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Physical Training in Glioblastoma Patients During Cytotoxic Therapy

NCT ID: NCT05015543

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-23

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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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

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Glioblastoma

Keywords

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sports Glioblastoma (GBM) physical training Quality of Life (QOL) Neuro-Oncology Psycho-Oncology fitness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients paticipating in the Personal Training Program

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

Group Type EXPERIMENTAL

Personal Training Program

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dorothee Wiewrodt, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Münster

Locations

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Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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MMH_01

Identifier Type: -

Identifier Source: org_study_id