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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828189
• Other study ID #: FPSM_UAH_VPG_2
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: January 2020

Study information

• Verified date: April 2021
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

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.

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

Other:
• Therapeutic exercise-Physiotherapy
Cardiovascular exercise Individualized progressive strength and resistance exercises of principals muscle groups of the lower limbs, upper limbs and trunk. Flexibilization exercises

Locations

Country	Name	City	State
Spain	Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective assessment of perception of fatigue.	FACIT-FatigueScale (total score)	6 months
Secondary	Subjective assessment of perception of dyspnoea	Borg Dyspnoea Test before and after "6-Minutes Walking Test (6MWT)"	6 months
Secondary	Distance in meters	Distance in meters during "6-Minutes Walking Test (6MWT)"	6 months
Secondary	Pain Intensity	Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".	6 months