Clinical Trials Directory

Trials / Completed

CompletedNCT01322412

Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer

Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase

Status
Completed
Phase
Study type
Observational
Enrollment
44 (actual)
Sponsor
University Hospital, Limoges · Academic / Other
Sex
Female
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2011-05-01
Primary completion
2013-05-01
Completion
2013-07-01
First posted
2011-03-24
Last updated
2018-08-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01322412. Inclusion in this directory is not an endorsement.