Physical Training in Glioblastoma Patients During Cytotoxic Therapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05015543
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Muenster
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dorothee Wiewrodt, PD Dr. med.
Principal Investigator Affiliation Universitätsklinikum Münster
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Patients paticipating in the Personal Training Program

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

Interventions

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.

Contact a Trial Team

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International Sites

Universitätsklinikum Münster, Münster, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Universitätsklinikum Münster

Münster, Nordrhein-Westfalen, 48149

Site Contact

Dorothee Wiewrodt, PD Dr. med.

[email protected]

+492518348305

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