Clinical trial NCT02828189: Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment
Official title: Efficacy of Therapeutic Exercise in Modulating Cancer-Related Fatigue in Women After Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Breast Cancer
Keywords: Physical Therapy Modalities
Breast Cancer Treatment
Exercise Therapy
Dyspnea
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective assessment of perception of fatigue.
timeFrame: 6 months
Secondary outcomes:
measure: Subjective assessment of perception of dyspnoea
timeFrame: 6 months
measure: Distance in meters
timeFrame: 6 months
measure: Pain Intensity
timeFrame: 6 months
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
state: Madrid
Study officials:
affiliation: University of Alcalá
name: Virginia Prieto Go´mez, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: