Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Therapeutic Exercise in Modulating Cancer-Related Fatigue in Women After Breast Cancer Treatment

Conditions
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Fatigue, Breast Cancer

Intervention / Treatment
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* Other: Physical Exercise
* Behavioral: Therapeutic Education
* Other: Therapeutic exercise-Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical Exercise<br>The protocol consists in: Physical Exercise according to their preferences. Therapeutic Education related to Health Habits and Physical Exercise. | Other: Physical Exercise<br>* The patients were instructed to perform autonomous physical exercise program based preferences (progressive march on flat ground, dancing, cycling, etc.). They will receive written information. The program is 9 weeks with a frequency of 3 days per week and sessions about 50 minutes long.<br>* Other names: Exercise;Behavioral: Therapeutic Education<br>* Individual Therapeutic Education about healthy habits and exercise on breast cancer.<br>* Other names: Hygienic and behavioral advises;|
| Experimental: Therapeutic Exercise-Physiotherapy<br>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. | Behavioral: Therapeutic Education<br>* Individual Therapeutic Education about healthy habits and exercise on breast cancer.<br>* Other names: Hygienic and behavioral advises;Other: Therapeutic exercise-Physiotherapy<br>* Cardiovascular exercise Individualized progressive strength and resistance exercises of principals muscle groups of the lower limbs, upper limbs and trunk. Flexibilization exercises<br>* Other names: Physiotherapy exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective assessment of perception of fatigue. | FACIT-FatigueScale (total score) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective assessment of perception of dyspnoea | Borg Dyspnoea Test before and after 6-Minutes Walking Test (6MWT) | 6 months | 
| Distance in meters | Distance in meters during 6-Minutes Walking Test (6MWT) | 6 months | 
| Pain Intensity | Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked no pain on the left side or worst imaginable pain. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Treatment, Physical Therapy Modalities, Exercise Therapy, Dyspnea