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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Daily physical activity | International Physical Activity Questionnaire (IPAQ). A higher score corresponds to a physically more intense activity. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Health-related quality of life questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marieke Blom, Msc | Contact | +31 6 21522442 | m.e.c.blom@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Centers, location VUmc | Recruiting | Amsterdam | 1081 HV | Netherlands |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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|
| VO2max |
Physical fitness defined as the maximal oxygen uptake measured with a cardiopulmonary exercise test. |
| Baseline versus post-intervention (12 weeks) |
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. |
| Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Perceived functional impairments | Work and Social Adjustment Scale (WSAS), consisting of 5 questions on a 8-point scale. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Self-efficacy | Exercise Self-Efficacy Scale (ESES), consisting of 10 questions on a 4-point scale. A higher score indicates higher exercise self-efficacy. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Mastery | Pearlin Mastery Scale (PMS), consisting of 7 items on a 4-point scale. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| 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. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Subjective Happiness | Subjective Happiness Scale (SHS), consisting of 4 questions on a 7-point scale. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| 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. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Subjective cognitive failure | Cognitive Failure Questionnaire (CFQ), consisting of 25 items on a 5-point scale. A higher score refers to more cognitive errors. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Fatigue questionnaire | Checklist Individual Strength (CIS20), consisting of measurements of fatigue severity, concentration problems, reduced motivation, and reduced activity. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Sleep questionnaire | Pittsburg Sleep Quality Index (PSQI) assesses sleep dysfunction over 1-month interval. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Anxiety questionnaire | Beck Anxiety Index (BAI), consisting of 21 questions on a 4-point scale. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Self-reported depression questionnaire | Beck Depression Index (BDI-PC), consisting of 21 questions on a 4-point scale. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Depression questionnaire | The Center for Epidemiologic Studies Depression questionnaire, consisting of twenty questions regarding symptoms of depression on a 4-point scale. | Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up) |
| Muscle strength | Hand-held dynamometer | Baseline versus post-intervention (12 weeks) |
| Subjective physical fitness | FitMax questionnaire, consisting of thee questions about the maximum capacity of walking, climbing, and cycling, estimating the VO2max. | Baseline versus post-intervention (12 weeks) |
| Objective neurocognitive functioning | Neuropsychological assessment (NPA), assessing different brain functions. | Baseline versus post-intervention (12 weeks) |
| Objective neurological functioning | Neurological assessment in neuro-oncology scale (NANO). A quantitative evaluation of 9 relevant neurologic domains. | Baseline versus post-intervention (12 weeks) |
| Brain imaging (optional) | MRI (magnetic resonance imaging) | Baseline versus post-intervention (12 weeks) |
| Brain activity (optional) | MEG (magnetoencephalography) | Baseline versus post-intervention (12 weeks) |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |