The primary objective is to investigate the efficacy of HIIT on self-reported physical fitness in primary brain tumor patients during stable disease. The secondary objective is to investigate the efficacy of HIIT on the maximal oxygen uptake (VO2max…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is self-reported physical fitness, measured by the
first question of the International Fitness Scale (IFIS), "Your general
physical fitness is?" On a scale of 1 ("very poor") to 5 ("very good").
Secondary outcome
The secondary outcome measure is maximum oxygen uptake (objective physical
fitness; VO2max), measured with a cardiopulmonary exercise test (CPET). In
addition, a set of exploratory outcomes will be measured to examine the effects
of the intervention. The measurements include a muscle strength measurement,
MRI (optional), MEG (optional), neuropsychological assessment and various
questionnaires. And last, focus groups will be planned to learn from patients
perspectives of participating in high-intensity interval training.
Last, we ask patients in the intervention and waiting-list control group to
keep an exercise diary in the first three weeks and last two weeks of the
intervention period, and the last two weeks of the follow-up period.
Background summary
Patients with a brain tumor may experience decreased physical fitness during
stable disease. This can affect daily functioning and quality of life. Exercise
programs are an effective and structured way to increase the amount of physical
activity and improve physical fitness. "High-intensity interval training"
(HIIT) is a promising form of exercise that shows positive effects in other
oncology patient groups.
Study objective
The primary objective is to investigate the efficacy of HIIT on self-reported
physical fitness in primary brain tumor patients during stable disease. The
secondary objective is to investigate the efficacy of HIIT on the maximal
oxygen uptake (VO2max; objectively measured physical fitness) in primary brain
tumor patients. In addition, we aim to explore additional effcts and potential
working mechanisms of HIIT in primary brain tumor patients, and we aim to
describe patient's perspectives of participating in high-intensity interval
training.
Study design
It is a monocenter randomized controlled trial with an intervention group and a
control group. The intervention group performs the exercise program, and the
control group is placed on a waiting list and can still perform the exercise
program after study participation.
First, patients are screened. Then the first study measurement takes place (T0)
and patients are randomized into the intervention or control group. After about
a week after the 12-week intervention (T1) and after 6 weeks of follow-up (T2),
the other study measurements take place. After this 18-week study period, focus
groups will be scheduled with the participants from the intervention group. The
participants from the control group can then possibly start the training
program.
Intervention
The intervention consists of performing a training program called
high-intensity interval training which lasts for 12 weeks with two training
sessions per week. The training sessions will be performed under supervision at
the Amsterdam UMC, location VUmc. All participants (intervention and control
group) also receive advice/information about the recommended amount of weekly
physical activity, and are asked to keep a diary about their amount of physical
actvity during 7 weeks of the study period.
Study burden and risks
Performing the high-intensity interval training program is a safe intervention.
Patients will be screened before study participation to check for
contraindications to (maximal) exercise, and to check the other inclusion and
exclusion criteria. This will be done partly by a rehabilitation physician,
with a cardiologist taking and assessing a resting ECG.
Patients will be randomized into an intervention group or (waiting list)
control group. The intervention group performs the training program which lasts
12 weeks with two training sessions per week. Each training session will take
20-30 minutes.
Measurements will take place before the intervention, after about a week after
the 12-week intervention and after 6 weeks follow-up. The measurement before
and after about a week post-intervention will take about 5.5 hours each (of
which approximately 1.5 hours is optional for MRI/MEG). Of these, the
measurements at VUmc will take about 4 hours (of which approximately 1.5 hours
is optional for MRI/MEG) and the questionnaires that can be completed from home
will take 1.5 hours. The follow-up measurement will consist only of
questionnaires and will take about 1.5 hours.
The measurements that will take place at VUmc are: neuropsychological
assessment, MRI scan (optional), MEG (optional) and a cardiopulmonary exercise
test with a muscle strength measurement.
In addition, participants from the intervention group and the control group
will be asked to keep an exercise diary for 7 weeks. Keeping the diary will
take a few minutes a day.
De Boelelaan 1108
Amsterdam 1081 HZ
NL
De Boelelaan 1108
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
- minimum age of 18 years;
- reduced self-reported physical fitness, defined as a score of "average",
"poor" or "very poor" on the first question of the International Fitness Scale
(IFIS): "My general physical fitness is?";
- diagnosed with a primary brain tumor;
- stable disease, i.e. no signs of radiological or clinical tumor progression;
- no oncological treatment for at least two months prior to inclusion;
- able to speak, read and write in Dutch.
Exclusion criteria
- Karnofsky Performance Score < 70; - already participated in a HIIT program <
1 month prior; - contraindication of exercise based on the guidelines by
American College of Sports Medicine (ACSM); - complaints of cardiovascular,
pulmonary, and/or metabolic abnormalities or cardiovascular, pulmonary, and/or
metabolic abnormalities that are not well controlled with medication, following
the Lausanne protocol, in accordance with the protocol on Kwaliteitsnet
*Bewegingslab ISL: beslisboom inspanningstest spiro-ergometrie-REV, serie 1* at
the department of Rehabilitation Medicine in Amsterdam UMC, location VUmc.
Design
Recruitment
Medical products/devices used
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 | NL84223.018.23 |