Physical Training in Glioblastoma Patients During Cytotoxic Therapy

NCT05015543 | Completed

• 1 other identifier: MMH_01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

1. 1.improves physical fitness
2. 2.increases quality of life/life satisfaction throughout the intervention
3. 3.can be detected in blood due to increased concentrations of brain-derived neurotrophic factor 1 (BDNF-1) (voluntary)

Conditions

Glioblastoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Between week 0 and 16.

Secondary Outcomes (7)

• Physical Work Capacity (PWC)

  Between week 0 and 16 (and 24).

• PWC

  after 8, 16 and 24 weeks

• Spiroergometry - maximal oxygen consumption (VO2max)

  Between week 0 and 16 (and 24).

• Spiroergometry - lactate

  Between week 0 and 16 (and 24).

• EORTC-QLQ-C30 Brain module

  Between week 0 and 16 (and 24).

Study Arms (1)

Patients paticipating in the Personal Training Program

EXPERIMENTAL

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

Other: Personal Training Program

Interventions

Personal Training Program 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.

Patients paticipating in the Personal Training Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Dorothee Wiewrodt, PD Dr. med.

  Universitätsklinikum Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 20, 2021
• Study Start: July 23, 2020
• Primary Completion: October 17, 2024
• Study Completion: December 1, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)