FatigueNCT02828189
Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment
A study testing Physical Exercise, Therapeutic Education and Therapeutic exercise-Physiotherapy in people with Fatigue and Breast Cancer, run by University of Alcala at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Fatigue, Breast Cancer
- What is being tested?
- Physical Exercise, Therapeutic Education and Therapeutic exercise-Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
Alcalá de Henares, Madrid, 28871
About this study
Official title: 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.
Read the 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
- Being tested
- Physical Exercise, Therapeutic Education, Therapeutic exercise-Physiotherapy
- Keywords
- Physical Therapy Modalities, Breast Cancer Treatment, Exercise Therapy, Dyspnea
- Medical subject headings
- Fatigue, Breast Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
Also called 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.
Therapeutic EducationBehavioural
Also called Hygienic and behavioral advises
Individual Therapeutic Education about healthy habits and exercise on breast cancer.
Therapeutic exercise-PhysiotherapyOther
Also called Physiotherapy exercise
- Cardiovascular exercise
- Individualized progressive strength and resistance exercises of principals muscle groups of the lower limbs, upper limbs and trunk.
- Flexibilization exercises
| Study group | Role | What they receive |
|---|---|---|
| Physical Exercise | Active comparator | The protocol consists in:
* Physical Exercise according to their preferences.
* Therapeutic Education related to Health Habits and Physical Exercise. Receives: Other: Physical Exercise; Behavioral: Therapeutic Education |
| Therapeutic Exercise-Physiotherapy | Experimental | 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. Receives: Behavioral: Therapeutic Education; Other: Therapeutic exercise-Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective assessment of perception of fatigue.
FACIT-FatigueScale (total score)
Measured: 6 months
Secondary outcomes (3)
Subjective assessment of perception of dyspnoea
Borg Dyspnoea Test before and after "6-Minutes Walking Test (6MWT)"
Measured: 6 months
Distance in meters
Distance in meters during "6-Minutes Walking Test (6MWT)"
Measured: 6 months
Pain Intensity
Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Prieto Gómez, University of Alcala
- Investigators
- Virginia Prieto Go´mez, PhD Student, Principal investigator, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828189
- Sponsor's protocol ID
- FPSM_UAH_VPG_2
- Status last verified
- Apr 2021
- First submitted
- 29 Jun 2016
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Therapeutic Exercise in Modulating Cancer-Related Fatigue in Women After Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT02828189
- Acronym / sponsor ID
- FPSM_UAH_VPG_2
- Conditions
- Fatigue, Breast Cancer
- Keywords
- Physical Therapy Modalities, Breast Cancer Treatment, Exercise Therapy, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise | Active comparator | Other: Physical Exercise, Behavioral: Therapeutic EducationThe protocol consists in: * Physical Exercise according to their preferences. * Therapeutic Education related to Health Habits and Physical Exercise. |
| Therapeutic Exercise-Physiotherapy | Experimental | Behavioral: Therapeutic Education, Other: Therapeutic exercise-PhysiotherapyThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExerciseAlso: ExerciseThe 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 | Physical Exercise |
| Therapeutic EducationAlso: Hygienic and behavioral advisesIndividual Therapeutic Education about healthy habits and exercise on breast cancer. | Behavioural | Physical Exercise, Therapeutic Exercise-Physiotherapy |
| Therapeutic exercise-PhysiotherapyAlso: Physiotherapy exercise1. 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 | Therapeutic Exercise-Physiotherapy |
Primary outcome
Subjective assessment of perception of fatigue.
Time frame: 6 months
FACIT-FatigueScale (total score)
3 secondary outcomes
Subjective assessment of perception of dyspnoea
Time frame: 6 months
Distance in meters
Time frame: 6 months
Pain Intensity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Individual participant dataSharing planned: No
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Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
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Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
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Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Prieto Go´mez, PhD Student principal investigator
University of Alcalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise, Therapeutic Education and Therapeutic exercise-Physiotherapy in people with Fatigue and Breast Cancer, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective assessment of perception of fatigue. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.