Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment
Efficacy of Therapeutic Exercise in Modulating Cancer-Related Fatigue in Women After Breast Cancer Treatment
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid
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Alcalá de Henares, Madrid, Spain, 28871
- Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Physical Exercise
The protocol consists in:
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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.
Other Names:
Individual Therapeutic Education about healthy habits and exercise on breast cancer.
Other Names:
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Experimental: Therapeutic Exercise-Physiotherapy
The protocol consists in:
|
Individual Therapeutic Education about healthy habits and exercise on breast cancer.
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective assessment of perception of fatigue.
Time Frame: 6 months
|
FACIT-FatigueScale (total score)
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective assessment of perception of dyspnoea
Time Frame: 6 months
|
Borg Dyspnoea Test before and after "6-Minutes Walking Test (6MWT)"
|
6 months
|
|
Distance in meters
Time Frame: 6 months
|
Distance in meters during "6-Minutes Walking Test (6MWT)"
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6 months
|
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Pain Intensity
Time Frame: 6 months
|
Visual analogue scale (VAS).100
mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Virginia Prieto Go´mez, PhD Student, University of Alcala
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPSM_UAH_VPG_2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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