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

April 20, 2021 updated by: Virginia Prieto Gómez, University of Alcala

Efficacy of Therapeutic Exercise in Modulating Cancer-Related Fatigue in Women After Breast Cancer Treatment

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28871
        • Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • Physical Exercise according to their preferences.
  • Therapeutic Education related to Health Habits and Physical Exercise.
Other: 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.
Other Names:
  • Exercise
Behavioral: Therapeutic Education
Individual Therapeutic Education about healthy habits and exercise on breast cancer.
Other Names:
  • Hygienic and behavioral advises
Experimental: 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.
Behavioral: Therapeutic Education
Individual Therapeutic Education about healthy habits and exercise on breast cancer.
Other Names:
  • Hygienic and behavioral advises
Other: 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
Other Names:
  • Physiotherapy exercise

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)
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)"
6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Virginia Prieto Go´mez, PhD Student, University of Alcala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

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)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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