Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer (SAPA)
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|ClinicalTrials.gov Identifier: NCT01322412|
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : January 13, 2014
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation.
Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.
|Condition or disease|
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. Cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.
A total of 44 subjects is required. The programme is organised as follows: Arm A (aerobic and strength training) and during the 27 weeks of treatment (chemotherapy and radiotherapy); Arm B (control group). This study includes 3 assessments phases (T0: before adjuvant chemotherapy; T1 (week 27) and T2: final evaluation at the 54th week). These assessments include: cardiopulmonary exercise test including maximal oxygen uptake test (VO2max), six-minute walk test, muscular testing, assessment of physical activity (IPAQ questionnaire), fatigue (MFI20 questionnaire), quality of life (EORTC QLQ C30), anxiety and depression symptoms (HADS) and nutritional evaluation: BMI and total body photonic absorption.
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|Official Title:||Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||July 2013|
Arm A : physical activity program
Arm A : physical activity program (aerobic and strength training) during the 27 weeks of treatment (chemotherapy and radiotherapy) and conventional follow-up during 27 weeks
Arm B : conventional management
Arm B : conventional management during and after treatment
- main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme [ Time Frame: 27 weeks ]
- Assessment at 27 and 54 weeks between the 2 groups of muscle function. [ Time Frame: 54 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322412
|Limoges University Hospital|
|Limoges, France, 87042|
|Principal Investigator:||Vincent FRANCOIS, MD||University Hospital, Limoges|