Effects of Exercise on Cognitive Function in Glioma Patients

NCT02303938 | Completed DMC

• 1 other identifier: NL44024.008.13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Grade Glioma of Brain; Anaplastic Glioma of Brain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Objective measures of physical fitness measured by cardiopulmonary exercise test (CPET)

  6 months after the initial assessment

Other Outcomes (3)

• Patient reported outcome measured with self-reported questionnaires

  6 months after the initial assessment

• Subjective cognition measured with Cognitive Functioning Scale (CFS) and Cognitive Failures Questionnaire (CFQ)

  6 months after the initial assessment

• Mental well-being measured with self-reported questionnaires

  6 months after the initial assessment

Study Arms (2)

physical exercise

EXPERIMENTAL

Patients will exercise three times per week for 6 months home-based exercise intervention. Session duration will vary between 20 minutes and 45 minutes.

Behavioral: physical exercise

Active control group

NO INTERVENTION

Patients in the active control group will be advised to walk regularly based on brochures from 30minutenbewegen.nl

Interventions

physical exercise BEHAVIORAL

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.

physical exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tilburg University: lead

Study Sites (1)

Tilburg University

Tilburg, Nood-Brabant, 5037 AB, Netherlands

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karin Gehring, PhD

  Tilburg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: December 1, 2014
• Study Start: August 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

NL (1)