Brain Tumor, PrimaryFeelFitNCT06282562
FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients
A study testing High-Intensity Interval Training (HIIT) in people with Brain Tumor, Primary and Exercise, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Primary, Exercise
- What is being tested?
- High-Intensity Interval Training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2024to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- reduced self-reported physical fitness;
- minimum age of 18 years;
- 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.
Who cannot join
- Karnofsky Performance Score < 70;
- already participated in a HIIT program < 1 month prior;
- contraindication of exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
VU University Medical Centers, location VUmc
Amsterdam, 1081 HV
Marieke Blom, Msc, +31621522442, gripopfitheid@amsterdamumc.nl
About this study
Official title: FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients: a Randomized Controlled Trial
The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients.
- Conditions
- Brain Tumor, Primary, Exercise
- Being tested
- High-Intensity Interval Training (HIIT)
- Medical subject headings
- Brain Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Training (HIIT)Other
Individualized High-Intensity Interval Training (HIIT) program with two exercise sessions per week for 12 weeks. The exercise sessions will be conducted on a stationary bike, with intensity tailored to each participant's maximum exercise capacity.
| Study group | Role | What they receive |
|---|---|---|
| HIIT | Experimental | The intervention group will perform High-Intensity Interval Training (HIIT), consisting of two supervised exercise sessions per week on a stationary bike, for 12 weeks.
In addition, participants will receive information on general guidelines for weekly physical activity levels and will be asked to keep an exercise diary. Receives: Other: High-Intensity Interval Training (HIIT) |
| Waiting-list | No intervention | The control group on the waiting list will be given the option to perform High-Intensity Interval Training (HIIT) after their participation in the study. In addition, also participants from the waiting-list control group will receive information on general guidelines for weekly physical activity levels and will be asked to keep an exercise diary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported physical fitness
Self-reported physical fitness is measured using the first question of the International Fitness Scale (IFIS) on general physical fitness, on a 5-point scale where a higher score corresponds to better self-reported physical fitness.
Measured: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
Secondary outcomes (2)
Self-reported fitness
In addition to the first question of the International Fitness Scale (IFIS), the other questions about cardiorespiratory fitness, muscle strength, speed and flexibility will also be asked as secondary outcomes.
Measured: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
VO2max
Physical fitness defined as the maximal oxygen uptake measured with a cardiopulmonary exercise test.
Measured: Baseline versus post-intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2024
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Douw, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282562
- Sponsor's protocol ID
- NL84223.018.23
- Acronym
- FeelFit
- Status last verified
- Apr 2025
- First submitted
- 6 Feb 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06282562
- Acronym / sponsor ID
- FeelFit / NL84223.018.23
- Conditions
- Brain Tumor, Primary, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT | Experimental | Other: High-Intensity Interval Training (HIIT)The intervention group will perform High-Intensity Interval Training (HIIT), consisting of two supervised exercise sessions per week on a stationary bike, for 12 weeks. In addition, participants will receive information on general guidelines for weekly physical activity levels and will be asked to keep an exercise diary. |
| Waiting-list | No intervention | –The control group on the waiting list will be given the option to perform High-Intensity Interval Training (HIIT) after their participation in the study. In addition, also participants from the waiting-list control group will receive information on general guidelines for weekly physical activity levels and will be asked to keep an exercise diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- reduced self-reported physical fitness;
- minimum age of 18 years;
- 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;
Key exclusion criteria (3 listed)
- Karnofsky Performance Score < 70;
- already participated in a HIIT program < 1 month prior;
- contraindication of exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval Training (HIIT)Individualized High-Intensity Interval Training (HIIT) program with two exercise sessions per week for 12 weeks. The exercise sessions will be conducted on a stationary bike, with intensity tailored to each participant's maximum exercise capacity. | Other | HIIT |
Primary outcome
Self-reported physical fitness
Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
Self-reported physical fitness is measured using the first question of the International Fitness Scale (IFIS) on general physical fitness, on a 5-point scale where a higher score corresponds to better self-reported physical fitness.
2 secondary outcomes
Self-reported fitness
Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
VO2max
Time frame: Baseline versus post-intervention (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training (HIIT) in people with Brain Tumor, Primary and Exercise, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marieke Blom, Msc (+31 6 21522442, m.e.c.blom@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported physical fitness (time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025; AzTrials last refreshed its copy on 29 Oct 2026.