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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02828189
Enrollment
80
Registered
2016-07-11
Start date
2016-07-31
Completion date
2020-01-31
Last updated
2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Fatigue

Keywords

Physical Therapy Modalities, Breast Cancer Treatment, Exercise Therapy, Dyspnea

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.

Interventions

OTHERPhysical 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.

BEHAVIORALTherapeutic Education

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

OTHERTherapeutic 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

Sponsors

University of Alcala
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Subjective assessment of perception of fatigue.6 monthsFACIT-FatigueScale (total score)

Secondary

MeasureTime frameDescription
Subjective assessment of perception of dyspnoea6 monthsBorg Dyspnoea Test before and after 6-Minutes Walking Test (6MWT)
Distance in meters6 monthsDistance in meters during 6-Minutes Walking Test (6MWT)
Pain Intensity6 monthsVisual analogue scale (VAS).100 mm horizontal with pain descriptors marked no pain on the left side or worst imaginable pain.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026