FeelFit: high-intensity interval training to improve self-reported physical fitness in brain tumor patients: a randomized controlled trial

Recruiting

Conditions: brain tumor
primary brain tumor
10029211

Registration Number: NL-OMON56527

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

- minimum age of 18 years;
- reduced self-reported physical fitness, defined as a score of average,
poor or very poor on the first question of the International Fitness Scale
(IFIS): My general physical fitness is?;
- 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 based on the guidelines by
American College of Sports Medicine (ACSM); - complaints of cardiovascular,
pulmonary, and/or metabolic abnormalities or cardiovascular, pulmonary, and/or
metabolic abnormalities that are not well controlled with medication, following
the Lausanne protocol, in accordance with the protocol on Kwaliteitsnet
*Bewegingslab ISL: beslisboom inspanningstest spiro-ergometrie-REV, serie 1* at
the department of Rehabilitation Medicine in Amsterdam UMC, location VUmc.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is self-reported physical fitness, measured by the<br /><br>first question of the International Fitness Scale (IFIS), Your general<br /><br>physical fitness is? On a scale of 1 (very poor) to 5 (very good). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measure is maximum oxygen uptake (objective physical<br /><br>fitness; VO2max), measured with a cardiopulmonary exercise test (CPET). In<br /><br>addition, a set of exploratory outcomes will be measured to examine the effects<br /><br>of the intervention. The measurements include a muscle strength measurement,<br /><br>MRI (optional), MEG (optional), neuropsychological assessment and various<br /><br>questionnaires. And last, focus groups will be planned to learn from patients<br /><br>perspectives of participating in high-intensity interval training.<br /><br><br /><br>Last, we ask patients in the intervention and waiting-list control group to<br /><br>keep an exercise diary in the first three weeks and last two weeks of the<br /><br>intervention period, and the last two weeks of the follow-up period. </p><br>