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

Exercise Clinical Trial

— FeelFit  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282562
• Other study ID #: NL84223.018.23
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: August 15, 2026

Study information

• Verified date: March 2024
• Source: Amsterdam UMC, location VUmc
• Contact: Marieke Blom, Msc
• Phone: +31 6 21522442
• Email: m.e.c.blom[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 15, 2026
• Est. primary completion date: August 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Primary
• Exercise

Intervention

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.

Locations

Country	Name	City	State
Netherlands	VU University Medical Centers, location VUmc	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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.	Baseline versus post-intervention (12 weeks) and versus follow-up (12 weeks and 6 weeks follow-up)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	Muscle strength	Hand-held dynamometer	Baseline versus post-intervention (12 weeks)
Other	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)
Other	Objective neurocognitive functioning	Neuropsychological assessment (NPA), assessing different brain functions.	Baseline versus post-intervention (12 weeks)
Other	Objective neurological functioning	Neurological assessment in neuro-oncology scale (NANO). A quantitative evaluation of 9 relevant neurologic domains.	Baseline versus post-intervention (12 weeks)
Other	Brain imaging (optional)	MRI (magnetic resonance imaging)	Baseline versus post-intervention (12 weeks)
Other	Brain activity (optional)	MEG (magnetoencephalography)	Baseline versus post-intervention (12 weeks)
Primary	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)
Secondary	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)
Secondary	VO2max	Physical fitness defined as the maximal oxygen uptake measured with a cardiopulmonary exercise test.	Baseline versus post-intervention (12 weeks)