NCT02828189

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Alcala · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-05-01
• Completion: 2020-01-01
• First posted: 2016-07-11
• Last updated: 2021-04-22

Locations

1 site across 1 country: Spain