The objective of this pilot randomized controlled trial (RCT) is to assess the feasibility and to determine the effect size of a physical activity/exercise program in improving objective cognitive functioning and reducing self-reported cognitive…
ID
Source
Brief title
Condition
- Other condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Health condition
cognitieve stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures will include indicators of feasibility (accrual,
adherence, compliance and attrition) and (size of the effect on) performance
scores on neuropsychological testing (attention, memory and executive
function).
Secondary outcome
Secondary outcome measures will include performance measures of physical
fitness as measured with CPET (cardiorespiratory exercise testing on a cycle
ergometer with ECG and gas exchange measurement), and self-report
questionnaires of subjective cognitive functioning, fatigue, sleep, mood and
quality of life.
Background summary
Many patients with glioma, the most common type of primary brain tumors, suffer
from cognitive deficits. Recent findings indicate that physical exercise may be
effective in delaying or ameliorating cognitive decline, in particular in older
adults and select neurological patient populations. Exercise interventions in
patients with cancer already demonstrated to have beneficial effects on
physical fitness, fatigue, psychological well-being, and quality of life.
Therefore, positive, broad effects of exercise on cognitive functioning,
physical fitness, fatigue, mood and quality of life in patients with primary
brain tumors are expected. Since there are no previous studies on exercise in
this patient group, this study will examine the feasibility of such a physical
exercise intervention for the improvement of cognitive functioning.
Study objective
The objective of this pilot randomized controlled trial (RCT) is to assess the
feasibility and to determine the effect size of a physical activity/exercise
program in improving objective cognitive functioning and reducing self-reported
cognitive symptoms and fatigue, and improving sleep, mood and quality life of
patients with low-grade glioma, and a subgroup of patients with anaplastic
glioma.
Study design
The study is designed as a *randomized*, single-blind controlled trial. Of the
170 patients that will be screened telephonically, with neuropsychological
testing and with CPET, 60 patients will be randomized with minimization.
Forty patients who will assigned to the intervention group will undergo the
6-month home-based exercise intervention. Twenty 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.
Intervention
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) 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. Exercise duration will be progressed during the
first 6 weeks, and exercise intensity will be progressed from week 6-12, while
maintaining exercise duration. Over the course of the six months of the
program, intensity will be progressed in a non-linear way from 55% to 80-85% of
the heart rate corresponding to VO2peak at the CPET. During the exercise
activities, patients will wear a combination of a training watch with heart
rate monitor and GPS which will register heart rate, route, speed and
distance.
In addition, the participant will regularly receive phone calls by the physical
therapist.
Patients in the active control group will be advised to walk regularly based on
brochures they will receive, downloaded from 30minutenbewegen.nl, and will
regularly receive phone calls from the research team.
Study burden and risks
Participants of both groups undergo a telephonic screening, and 2
neuropsychological assessments at the patients* home, each consisting of a
maximum of 10 tests, with a maximum duration of 2 hours per assessment. A total
of 14 questionnaires can be filled in afterwards (1.5 hour). These assessments
will require some mental effort from patients. In addition, patients will
undergo 2 CPETs in a Sports Medical Center in the proximity of their home,
which will require physical effort for approximately 10 minutes. Based on the
CPET outcome, the intervention group will undergo an individually tailored (and
therefore most safe), home-based, intensive exercise program (total duration of
49 hours in 6 months; plus some additional time for phone contact with physical
therapist), whereas the control group will be advised to walk regularly as
prescribed by the Dutch public guidelines for healthy physical activity.
Broad benefits for patients in the intervention group are expected on physical
fitness, cognitive function, fatigue, sleep, mood and quality of life, and will
outweigh the small risks of exercise (of which the most severe can be safely
detected prior to intervention start by CPET). The additional risks that
patients face from the intervention are risks on sports injuries, and falls.
Risk of injury is minimized by a thorough physical examination at the screening
phase by a physician in the Sports Medical Center, by the build-up of the
exercise program (e.g., by keeping the intensity level low during the first
weeks), and by the (distant) monitoring by the physical therapist.
Patients from the control group who complete all study assessments will receive
a Polar training watch with heart rate monitor, and an individualized exercise
prescription based on the CPET-outcome, if they wish to. These patients will
not receive any further supervision by the research team.
Warandelaan 2
Tilburg 5037 AB
NL
Warandelaan 2
Tilburg 5037 AB
NL
Listed location countries
Age
Inclusion criteria
Adult patients with supratentorial glioma, in particular:
(1a) histologically proven low-grade glioma (LGG; astrocytoma, oligodendroglioma, oliogo-astrocytoma), or presumed (i.e., suspected) LGG based on both clinical and MR imaging features (>18 years of age < 70); or
(1b) anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oliogo-astrocytoma) under age 50 and with good performance status (KPS > 70),
who:
(2) have been clinically stable for a minimum of 6 months prior to study entry (as determined by recent CT or MR imaging); and
(3) have had no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids); and
(4) are interested in undergoing a physical exercise program; and
(5) have a relative VO2peak (% predicted based on variables such as age and gender) that leaves room for further improvement of cardiorespiratory fitness.
Exclusion criteria
Potentially eligible patients will be screened for the presence of comorbid conditions that would contraindicate participation in a physical activity/exercise program. This includes patients with serious orthopedic conditions or motor deficits, and patients with serious cardiovascular, cardiopulmonary and neurological conditions (or risks) who would not be able to train at the intensity level required by the programs. Patients judged to have psychiatric (including alcohol and drug abuse) or severe cognitive problems that would preclude them from program participation will be excluded from the study. For assessment purposes, study participants will need to have basic fluency in the Dutch language.
In addition, patients who report to engage in vigorous exercise (>=7 METs (Metabolic equivalents of task)) for more than 20 minutes on at least 3 days per week on a regular basis will be excluded from participation, as there will be no room for further improvement of aerobic fitness.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44024.008.13 |