Clinical trial NCT06282562: FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients
Official title: FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumor, Primary
Exercise
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility 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.

Primary outcomes:
measure: Self-reported physical fitness
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
Secondary outcomes:
measure: Self-reported fitness
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: VO2max
timeFrame: Baseline versus post-intervention (12 weeks)
Other outcomes:
measure: Daily physical activity
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Health-related quality of life questionnaire
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Perceived functional impairments
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Self-efficacy
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Mastery
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Brain tumor specific quality of life questionnaire
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Subjective Happiness
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Subjective cognitive functioning
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Subjective cognitive failure
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Fatigue questionnaire
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Sleep questionnaire
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Anxiety questionnaire
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Self-reported depression questionnaire
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Depression questionnaire
timeFrame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
measure: Muscle strength
timeFrame: Baseline versus post-intervention (12 weeks)
measure: Subjective physical fitness
timeFrame: Baseline versus post-intervention (12 weeks)
measure: Objective neurocognitive functioning
timeFrame: Baseline versus post-intervention (12 weeks)
measure: Objective neurological functioning
timeFrame: Baseline versus post-intervention (12 weeks)
measure: Brain imaging (optional)
timeFrame: Baseline versus post-intervention (12 weeks)
measure: Brain activity (optional)
timeFrame: Baseline versus post-intervention (12 weeks)
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Centers, location VUmc
Study officials:
References: