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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Brain Tumor, Primary
• Intervention / Treatment: Other: High-Intensity Interval Training (HIIT)

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marieke Blom, Msc; Phone Number: +31 6 21522442; Email: m.e.c.blom@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • VU University Medical Centers, location VUmc
    • Contact: Marieke Blom, Msc; Phone Number: +31621522442; Email: gripopfitheid@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
VO2max	Physical fitness defined as the maximal oxygen uptake measured with a cardiopulmonary exercise test.	Baseline versus post-intervention (12 weeks)

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: NL84223.018.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No