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

NCT06282562 | Recruiting

• 1 other identifier: NL84223.018.23
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumor, Primary; Exercise

Outcome Measures

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.

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

Secondary Outcomes (2)

• Self-reported fitness

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

• VO2max

  Baseline versus post-intervention (12 weeks)

Other Outcomes (20)

• Daily physical activity

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

• Health-related quality of life questionnaire

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

• Perceived functional impairments

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

Study Arms (2)

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.

Other: High-Intensity Interval Training (HIIT)

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.

Interventions

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.

HIIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• able to speak, read and write in Dutch.

You may not qualify if:

• Karnofsky Performance Score \< 70;
• already participated in a HIIT program \< 1 month prior;
• contraindication of exercise.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University Medical Centers, location VUmc

Amsterdam, 1081 HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Marieke Blom, Msc

CONTACT

+31 6 21522442; m.e.c.blom@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)