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

University of Alcala

Status: Completed

Conditions: Breast Cancer; Fatigue

Treatments: Other: Therapeutic exercise-Physiotherapy; Other: Physical Exercise; Behavioral: Therapeutic Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02828189

FPSM_UAH_VPG_2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Physical Exercise

Active Comparator group

Description:

The protocol consists in: * Physical Exercise according to their preferences. * Therapeutic Education related to Health Habits and Physical Exercise.

Treatment:

Behavioral: Therapeutic Education

Other: Physical Exercise

Therapeutic Exercise-Physiotherapy

Experimental group

Description:

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.

Treatment:

Behavioral: Therapeutic Education

Other: Therapeutic exercise-Physiotherapy