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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Exercise | Active Comparator | The protocol consists in:
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| Therapeutic Exercise-Physiotherapy | Experimental | The protocol consists in:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective assessment of perception of fatigue. | FACIT-FatigueScale (total score) | 6 months |
| 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)" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Prieto Go´mez, PhD Student | University of Alcalá | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala. | Alcalá de Henares | Madrid | 28871 | Spain |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D001943 | Breast Neoplasms |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Therapeutic Education | Behavioral | Individual Therapeutic Education about healthy habits and exercise on breast cancer. |
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| Therapeutic exercise-Physiotherapy | Other |
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| 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 |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |