Physical Training in Glioblastoma Patients During Cytotoxic Therapy

Glioblastoma Clinical Trial

— MMH  

Official title:

Glioblastoma and Sports - Does a Personal Training Program Improve Physical Performance and Quality of Life of Brain Tumor Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015543
• Other study ID #: MMH_01
• Status: Recruiting
• Phase: N/A
• Start date: July 23, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University Hospital Muenster
• Contact: Dorothee Wiewrodt, PD Dr. med.
• Phone: +49 251 83 48305
• Email: dorothee.wiewrodt[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Münster	Münster	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Between week 0 and 16 (and 24).
Secondary	PWC	changes over time, follow-up	after 8, 16 and 24 weeks
Secondary	Spiroergometry - maximal oxygen consumption (VO2max)	Changes in the maximal oxygen consumption (measured during spiroergometry)	Between week 0 and 16 (and 24).
Secondary	Spiroergometry - lactate	Changes in the individual anaerobic lactate threshold (measured during spiroergometry)	Between week 0 and 16 (and 24).
Secondary	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.	Between week 0 and 16 (and 24).
Secondary	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.	Between week 0 and 16 (and 24).
Secondary	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.	Between week 0 and 16 (and 24).