Effects of Exercise on Cognitive Function in Glioma Patients

Low Grade Glioma of Brain Clinical Trial

Official title:

A Pilot Randomized Controlled Trial on the Feasibility and Efficacy of an Exercise Intervention to Improve Cognitive Functioning in Patients With Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303938
• Other study ID #: NL44024.008.13
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: August 3, 2015
• Start date: August 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: University of Tilburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

The objective of this pilot randomized controlled trial (RCT) is to assess the feasibility and to determine the effect size of an exercise program in improving objective cognitive functioning.

Description:

Clinical stable patients with 1) low grade glioma (LGG) or 2) anaplastic glioma under age 70 will undergo a home-based exercise program (intervention) or will be assigned to the active controle group. Patients in the intervention group will undergo a 6-month home-based exercise intervention. An individual exercise prescription will be based on the patients' level of aerobic fitness (VO2peak) as measured with cardiopulmonary testing (CPET; on a cycle ergometer with ECG and gas exchange measurement) at baseline. Patients will exercise (e.g., running, biking, swimming) three times per week for 6 months. Session duration will vary between 20 minutes and 45 minutes. Patients in the active control group will be advised to walk regularly based on brochures from 30minutenbewegen.nl.

All primary and secondary outcomes will be assessed at baseline (T0; prior to randomization), and at completion of the 6-month exercise intervention (T1), and at a similar time-point for patients in the active control group. These will include indicators of feasibility (accrual, adherence, compliance and attrition), subjective and objective physical fitness measures, neuropsychological performance scores, and self-reported cognitive symptoms and mental wellbeing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Grade II and III gliomas

• age < 50 years

• Karnofsky score > or equal 80

• clinically stable for a minimum of 6 months prior to study entry

• no recent anti-tumor treatment

• interested in undergoing a physical exercise program

• mild to moderate neuropsychological impairment based on normative comparison of objective test performance

• relative VO2peak that leaves room for further improvement of cardiorespiratory fitness.

Exclusion Criteria:

• patients with serious orthopedic conditions or motor deficits

• patients with serious cardiovascular, cardiopulmonary and neurological conditions (or risks)

• patients judged to have psychiatric (including alcohol and drug abuse)

• patients with severe cognitive problems

• patients who report to engage in vigorous exercise (=7 METs) for more than 20 minutes on at least 3 days per week on a regular basis will be excluded

For assessment purposes, study participants will need to have basic fluency in the Dutch language.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaplastic Glioma of Brain
• Glioma
• Low Grade Glioma of Brain

Intervention

Behavioral:
• physical exercise
Patients in the intervention group will undergo a 6-month home-based exercise intervention. Patients will exercise (e.g., running, biking, swimming) three times per week for 6 months. Session duration will vary between 20 minutes and 45 minutes.

Locations

Country	Name	City	State
Netherlands	Tilburg University	Tilburg	Nood-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
University of Tilburg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient reported outcome measured with self-reported questionnaires	mood, sleep, fatique, quality of life, and depression are measured with self-reported questionaires at baseline and after intervention at 6 months such as Profile of Mood States (POMS) brief, Multidimensional Fatigue Inventory (MFI), Pittsburgh Sleep Inventory, MOS SF-36 Item Health Survey SF-36, and Brain-cancer specific HRQL questionnaire (QLQ-BN20)	6 months after the initial assessment	No
Other	Subjective cognition measured with Cognitive Functioning Scale (CFS) and Cognitive Failures Questionnaire (CFQ)	Subjective cognition is measured with self-reported questionaire at baseline and after intervention at 6 months	6 months after the initial assessment	No
Other	Mental well-being measured with self-reported questionnaires	Mental well-being is measured with specific questionaire at baseline and after intervention at 6 months	6 months after the initial assessment	No
Primary	cognitive function as measured by neuropsychological tests	neuropsychological test battery will be administered to patients at baseline and immediately after the intervention at 6 months	6 months after the initial assessment	No
Secondary	Objective measures of physical fitness measured by cardiopulmonary exercise test (CPET)	Intervention-related improvement of physical fitness will be assessed with a maximum cardiopulmonary exercise test (CPET). VO2 and of course adverse events are recorded immediately after the intervention ended at 6 months	6 months after the initial assessment	Yes