FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Karnofsky Performance Score < 70; - already participated in a HIIT program < 1 month prior; - contraindication of exercise.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06282562
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Amsterdam UMC, location VUmc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor, Primary, Exercise

Arms & Interventions

Arms

Experimental: 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.

No Intervention: Waiting-list

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.

Interventions

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Amsterdam, Netherlands

Status

Recruiting

Address

VU University Medical Centers, location VUmc

Amsterdam, , 1081 HV

Site Contact

Marieke Blom, Msc

[email protected]

+31621522442

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