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NCT Number: NCT06282562

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

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.

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Key information

Conditions

Brain Tumor, Primary Behavior Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Exercise Motor Activity Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU University Medical Centers, location VUmc

Amsterdam, 1081 HV, Netherlands

Location status: Recruiting

Location contact

Marieke Blom, Msc

CONTACT

[email protected]

+31621522442

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Self-reported fitness

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    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.

  2. VO2max

    Time frame: Baseline versus post-intervention (12 weeks)

    Physical fitness defined as the maximal oxygen uptake measured with a cardiopulmonary exercise test.

Other outcomes

  1. Daily physical activity

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    International Physical Activity Questionnaire (IPAQ). A higher score corresponds to a physically more intense activity.

  2. Health-related quality of life questionnaire

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ_C30) consists of 30 items and includes five functional scales, three symptom scales, a global health status/quality of life scale, and several single items assessing additional symptoms. The subscales are scored from 0-100 with higher scores representing better quality of life, better functioning, or a higher symptom burden.

  3. Perceived functional impairments

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Work and Social Adjustment Scale (WSAS), consisting of 5 questions on a 8-point scale.

  4. Self-efficacy

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Exercise Self-Efficacy Scale (ESES), consisting of 10 questions on a 4-point scale. A higher score indicates higher exercise self-efficacy.

  5. Mastery

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Pearlin Mastery Scale (PMS), consisting of 7 items on a 4-point scale.

  6. Brain tumor specific quality of life questionnaire

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-BN20, specific for brain tumor patients.

  7. Subjective Happiness

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Subjective Happiness Scale (SHS), consisting of 4 questions on a 7-point scale.

  8. Subjective cognitive functioning

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), consisting of 37 items on a 5-point scale. A higher score means better cognitive functioning.

  9. Subjective cognitive failure

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Cognitive Failure Questionnaire (CFQ), consisting of 25 items on a 5-point scale. A higher score refers to more cognitive errors.

  10. Fatigue questionnaire

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Checklist Individual Strength (CIS20), consisting of measurements of fatigue severity, concentration problems, reduced motivation, and reduced activity.

  11. Sleep questionnaire

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Pittsburg Sleep Quality Index (PSQI) assesses sleep dysfunction over 1-month interval.

  12. Anxiety questionnaire

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Beck Anxiety Index (BAI), consisting of 21 questions on a 4-point scale.

  13. Self-reported depression questionnaire

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    Beck Depression Index (BDI-PC), consisting of 21 questions on a 4-point scale.

  14. Depression questionnaire

    Time frame: Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)

    The Center for Epidemiologic Studies Depression questionnaire, consisting of twenty questions regarding symptoms of depression on a 4-point scale.

  15. Muscle strength

    Time frame: Baseline versus post-intervention (12 weeks)

    Hand-held dynamometer

  16. Subjective physical fitness

    Time frame: Baseline versus post-intervention (12 weeks)

    FitMax questionnaire, consisting of thee questions about the maximum capacity of walking, climbing, and cycling, estimating the VO2max.

  17. Objective neurocognitive functioning

    Time frame: Baseline versus post-intervention (12 weeks)

    Neuropsychological assessment (NPA), assessing different brain functions.

  18. Objective neurological functioning

    Time frame: Baseline versus post-intervention (12 weeks)

    Neurological assessment in neuro-oncology scale (NANO). A quantitative evaluation of 9 relevant neurologic domains.

  19. Brain imaging (optional)

    Time frame: Baseline versus post-intervention (12 weeks)

    MRI (magnetic resonance imaging)

  20. Brain activity (optional)

    Time frame: Baseline versus post-intervention (12 weeks)

    MEG (magnetoencephalography)

Study contacts

Contact information is provided by the study sponsor or research team.

Marieke Blom, Msc

CONTACT

[email protected]

+31 6 21522442

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Acronym: FeelFit

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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