Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment
- Conditions
- FatigueBreast Cancer
- Interventions
- Other: Physical ExerciseOther: Therapeutic exercise-PhysiotherapyBehavioral: Therapeutic Education
- Registration Number
- NCT02828189
- Lead Sponsor
- University of Alcala
- Brief Summary
The main objective of this study is to determine whether the proposed program of therapeutic exercise is effective in improving fatigue, more than the exercise unsupervised depending on their preferences, in women treated for breast cancer.
- Detailed Description
Introduction: The prevalence of cancer-related fatigue in women treated for breast cancer is about 30% having significant effects in reducing their quality of life. There is evidence of the presence of sleep problems and immune response. Several studies claim that physical exercise is effective during and after treatment of the disease as it improves the quality of life, cardiorespiratory function, physical functioning and symptoms of fatigue although not always found significant differences between intervention groups exercises compared with a control group. Although the results of these studies are promising, generally present methodological biases as small sample size, absence of masking, heterogeneous groups, lack of monitoring short and long term and especially lack of specificity in relation to prescribed exercise ( frequency, intensity, time and type of exercise).
Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to two groups:
An experimental group, where the participants will be treated with Therapeutic Exercise;
And a group where will be done Physical Exercise according their preferences.
Pre-intervention, immediate post-intervention, 3 and 6 months assessments will be made. The selection criteria will be: Adult women treated for breast cancer, completed at least 6 months before, with persistent fatigue. All participants must understand and sign freely Informed Consent.
Sample size: 40 women for each group.
Data Analysis: A descriptive analysis of all variables was performed. It establish for all cases a confidence level of 95% (p \<0.05). The effectiveness was assessed by comparing the experienced change of the two groups in outcome variables between physical therapy examinations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- Women treated for breast cancer, completed at least 6 months before, with persistent fatigue.
- Women who do not present contraindications for physiotherapy and physical exercise (infection, metastasis, loco regional recurrence, cardiopulmonary disorders).
- Women who have read, understood and signed informed consent freely.
- Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Therapeutic Exercise-Physiotherapy Therapeutic exercise-Physiotherapy The protocol consists in: * Cardiovascular exercise. * Force-Resistance Exercises of the principals muscle groups of the lower limbs, upper limbs and trunk. * Muscle Stretches. * Therapeutic Education related to Health Habits and Physical Exercise. Physical Exercise Therapeutic Education The protocol consists in: * Physical Exercise according to their preferences. * Therapeutic Education related to Health Habits and Physical Exercise. Therapeutic Exercise-Physiotherapy Therapeutic Education The protocol consists in: * Cardiovascular exercise. * Force-Resistance Exercises of the principals muscle groups of the lower limbs, upper limbs and trunk. * Muscle Stretches. * Therapeutic Education related to Health Habits and Physical Exercise. Physical Exercise Physical Exercise The protocol consists in: * Physical Exercise according to their preferences. * Therapeutic Education related to Health Habits and Physical Exercise.
- Primary Outcome Measures
Name Time Method Subjective assessment of perception of fatigue. 6 months FACIT-FatigueScale (total score)
- Secondary Outcome Measures
Name Time Method Distance in meters 6 months Distance in meters during "6-Minutes Walking Test (6MWT)"
Pain Intensity 6 months Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".
Subjective assessment of perception of dyspnoea 6 months Borg Dyspnoea Test before and after "6-Minutes Walking Test (6MWT)"
Trial Locations
- Locations (1)
Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
🇪🇸Alcalá de Henares, Madrid, Spain