Effectiveness of physical exercise during chemotherapy to improve physical fitness and reduce fatigue: A randomized trial
- Conditions
- breast cancer en colon cancer10006291
- Registration Number
- NL-OMON32716
- Lead Sponsor
- ederlands Kanker Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 360
Patients with histologically confirmed primary breast or primary colon cancer who are scheduled to undergo adjuvant chemotherapy with curative intent.
Patients with comorbid conditions that would contraindicate participation in a physical activity/exercise program.
This includes patients with serious orthopedic conditions that would hamper functional recovery, and patients with serious cardiovascular or cardiopulmonary conditions (or risks) who would not be able to train at the intensity level required by the programs. Patients suffering from malnutrition as evidenced by a BMI < 18 kg/m2, unintended weight loss of more than 5% per month, or more than 10% unintended weight loss during the previous 6 month period will be considered poor candidates for physical condition training and thus will not be eligible for participation. Patients judged to have serious psychiatric or cognitive problems that would preclude them from program participation will be excluded from the study. For assessment purposes, study participants will need to have basic fluency in the Dutch language. Patients participating in concurrent studies or rehabilitation programs containing elements of physical activity or exercise will also be considered ineligible for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcomes will be physical fitness as assessed with objective<br /><br>performance indicators, and self-reported fatigue. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study outcomes will include self-reported physical activity and<br /><br>physical functioning, mood state and HRQL. Additionally, compliance and<br /><br>satisfaction with the interventions will be evaluated by self-report.<br /><br><br /><br>Potential moderating variables, including pre- and post-illness lifestyle, and<br /><br>health- and exercise-related attitudes, beliefs and motivation, will also be<br /><br>assessed.</p><br>