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

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• Brain Neoplasms 1,960

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's planned enrollment of 36 is close to the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.

Study 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.

  Other: High-Intensity Interval Training (HIIT)

• 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

• OtherHigh-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.

Primary outcomes

1. 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.

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

Secondary outcomes

1. 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.

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

2. VO2max

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

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

Other outcomes

1. Daily physical activity

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

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

2. Health-related quality of life questionnaire

   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.

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

3. Perceived functional impairments

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

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

4. Self-efficacy

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

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

5. Mastery

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

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

6. Brain tumor specific quality of life questionnaire

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

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

7. Subjective Happiness

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

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

8. Subjective cognitive functioning

   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.

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

9. Subjective cognitive failure

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

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

10. Fatigue questionnaire

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

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

11. Sleep questionnaire

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

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

12. Anxiety questionnaire

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

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

13. Self-reported depression questionnaire

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

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

14. Depression questionnaire

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

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

15. Muscle strength

    Hand-held dynamometer

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

16. Subjective physical fitness

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

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

17. Objective neurocognitive functioning

    Neuropsychological assessment (NPA), assessing different brain functions.

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

18. Objective neurological functioning

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

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

19. Brain imaging (optional)

    MRI (magnetic resonance imaging)

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

20. Brain activity (optional)

    MEG (magnetoencephalography)

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

Individual participant data

Plan to share: No