FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Karnofsky Performance Score < 70;
already participated in a HIIT program < 1 month prior;
contraindication of exercise.
Trial design
Design model
Parallel
Treatments tested in this trial
High-Intensity Interval Training (HIIT)
Other interventionIndividualized 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: HIITExperimental treatment 1 intervention
Group B: Waiting-listNo intervention 0 interventions
Trial outcomes
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov