Optimal Timing of a tailored Physical Activity program during chemotherapeutic Cancer Treatment to reduce long-term cardiovascular morbidity.

Completed

Conditions: cardiovasculaire aandoeningen
cardiovascular effect after chemotherapy
10000546
10027656

Registration Number: NL-OMON47553

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 275

Inclusion Criteria

- Patients with testicular, early colon, early breast cancer or B-cell non-Hodgkin lymphoma (B-NHL) with an indication for systemic chemotherapy with a curative intent
- Normal blood count at start of systemic treatment
- Patients need to have an adequate physical health, which is defined by diastolic blood pressure >45 mm Hg or <95 mm Hg; heart frequency in at rest < 100 per minute; body temperature below 38°C; respiration frequency in rest below 20 per minute
- Written informed consent
- Adequate cardiac function with a LVEF above the lower limit of normal

Exclusion Criteria

- infections requiring actual antibiotics
- signs of ongoing bleeding or fresh petechiae; unexplained bruises
- critical organ impairment due to their malignancy
- not recovered from earlier surgical intervention
- non adequate control of any symptoms of the malignancy
- inability to travel independently to the rehabilitation centre
- cognitive disorder or emotional instability that might impede the participation in the training program
- recent cardiovascular event

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the difference in VO2 max between the groups 1 year<br /><br>after completion of the PA program. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will be muscle strength, change in metabolic and<br /><br>cardiovascular damage parameters, cardiovascular risk factors, cellular<br /><br>senescence and quality of life including self-efficacy, fatigue, motivation for<br /><br>exercise and physical activity level. </p><br>