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Completed

NCT Number: NCT02828189

Therapeutic Exercise in 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.

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Alcalá de Henares, Madrid, 28871, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical exercise

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.

Other names: Exercise

Therapeutic education

Behavioral

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

Other names: Hygienic and behavioral advises

Therapeutic exercise-Physiotherapy

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

Other names: Physiotherapy exercise

Primary outcomes

  1. Subjective assessment of perception of fatigue.

    Time frame: 6 months

    FACIT-FatigueScale (total score)

Secondary outcomes

  1. Subjective assessment of perception of dyspnoea

    Time frame: 6 months

    Borg Dyspnoea Test before and after "6-Minutes Walking Test (6MWT)"

  2. Distance in meters

    Time frame: 6 months

    Distance in meters during "6-Minutes Walking Test (6MWT)"

  3. 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".

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jul 11, 2016
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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