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

NCT ID: NCT02828189

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-01-31

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.

Conditions

Fatigue; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Exercise

The protocol consists in:

• Physical Exercise according to their preferences.
• Therapeutic Education related to Health Habits and Physical Exercise.

Group Type: ACTIVE_COMPARATOR

Physical Exercise

Intervention Type: 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.

Therapeutic Education

Intervention Type: BEHAVIORAL

Individual Therapeutic Education about healthy habits and exercise on breast cancer.

Therapeutic Exercise-Physiotherapy

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.

Group Type: EXPERIMENTAL

Therapeutic Education

Intervention Type: BEHAVIORAL

Individual Therapeutic Education about healthy habits and exercise on breast cancer.

Therapeutic exercise-Physiotherapy

Intervention Type: OTHER

1. Cardiovascular exercise

2. Individualized progressive strength and resistance exercises of principals muscle groups of the lower limbs, upper limbs and trunk.

3. Flexibilization exercises

Interventions

Physical Exercise

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.

Intervention Type: OTHER

Therapeutic Education

Individual Therapeutic Education about healthy habits and exercise on breast cancer.

Intervention Type: BEHAVIORAL

Therapeutic exercise-Physiotherapy

1. Cardiovascular exercise

2. Individualized progressive strength and resistance exercises of principals muscle groups of the lower limbs, upper limbs and trunk.

3. Flexibilization exercises

Intervention Type: OTHER

Other Intervention Names

Exercise; Hygienic and behavioral advises; Physiotherapy exercise

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Virginia Prieto Gómez

Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Virginia Prieto Go´mez, PhD Student

Role: PRINCIPAL_INVESTIGATOR

University of Alcalá

Locations

Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.

Alcalá de Henares, Madrid, Spain

Countries

Spain

Other Identifiers

FPSM_UAH_VPG_2

Identifier Type: -

Identifier Source: org_study_id