Breast NeoplasmsNCT06905639
Impact of Physical Exercise on Lymphedema Related to Breast Cancer: Assessment Using Thermography
A study testing Aerobic and Strength Exercise in people with Breast Neoplasms and Lymphedema, run by Marta Arias Crespo at 1 site in Spain.
Trial summary
Study Type: Clinical Trial Primary Purpose: To determine whether physical exercise improves or prevents lymphedema in breast cancer patients. Description of the Participant Population/Main Condition: The study is aimed at women who have been diagnosed with breast cancer and have experienced post-treatment lymphedema… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Lymphedema, Thermography
- What is being tested?
- Aerobic and Strength Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2025to 30 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18 years old diagnosed with breast cancer.
- Residing in the province of León.
- Not currently undergoing any physical exercise intervention at the time of the study.
- Not participating in lifestyle modification programs at the time of the study.
- Not presenting any relative or absolute sequelae from chemotherapy treatment that would pose a relative or absolute contraindication to their participation in this intervention (e.g., cardiological sequelae).
- Having signed the informed consent to participate in the study.
Who cannot join
- Presenting physical and/or psychological limitations that would hinder understanding or the ability to carry out the established intervention program.
- Presenting an infection in the upper limbs or lymphangitis.
- Fluid accumulation in the breast area requiring drainage at the time of the intervention.
- Not having signed the informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Study Type: Clinical Trial
Primary Purpose: To determine whether physical exercise improves or prevents lymphedema in breast cancer patients.
Read more
Description of the Participant Population/Main Condition: The study is aimed at women who have been diagnosed with breast cancer and have experienced post-treatment lymphedema or are at risk of developing it. The target population includes adults aged 18 to 70 who have been diagnosed with this condition following their breast cancer treatment.
Main Research Questions:
Does physical exercise improve or prevent lymphedema in women with breast cancer? What are the effects of physical exercise on the reduction of arm volume affected by lymphedema? What are the effects of physical exercise on the reduction of perceived disability in the arm affected by lymphedema?
Hypothesis:
Physical exercise intervention significantly reduces lymphedema symptoms, such as arm volume. Physical exercise prevents the progression of lymphedema in women with breast cancer.
Comparison Group: Researchers will compare results between the experimental group (which will undergo physical exercise) and the control group (which will receive no intervention) to determine if physical exercise has a significant impact on the improvement or prevention of lymphedema.
Participant Tasks:
The experimental group will follow a supervised physical exercise program for a specific period. The control group will receive no intervention and will be monitored with standard follow-up care without exercise. Participants will be evaluated before and after the study period to measure the progression of lymphedema, including arm volume measurement and surface skin temperature using thermography.
- Conditions
- Breast Neoplasms, Lymphedema, Thermography, Exercise
- Being tested
- Aerobic and Strength Exercise
- Keywords
- Breast Neoplasms, Lymphedema, Exercise, Thermography
- Medical subject headings
- Breast Neoplasms, Lymphedema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and Strength ExerciseBehavioural
A supervised physical exercise intervention was carried out, specifically designed to improve post-breast cancer lymphedema. The program will include a combination of strength exercises and aerobic exercises, with the aim of improving mobility, reducing inflammation, and increasing muscle strength in the arm affected by lymphedema
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION GROUP | Experimental | This arm of the study consists of participants who will receive a supervised physical exercise intervention specifically designed to improve post-breast cancer lymphedema. The program includes a combination of strength exercises and aerobic exercises, aimed at improving mobility, reducing injury, and increasing muscle strength in the arm affected by lymphedema Receives: Behavioral: Aerobic and Strength Exercise |
| CONTROL GROUP | No intervention | This arm of the study includes participants who will not receive any exercise intervention. They will continue with their usual daily routine and will be monitored throughout the study to compare changes in lymphedema between the intervention group and the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perimeters
The perimeter of the arm affected by lymphedema will be measured to assess the reduction in lymphedema volume in the participants. This measurement will be taken before and after the intervention to compare changes and determine the impact of physical exercise on inflammation and the size of the affected arm
Measured: 10 weeks
Thermography
Thermography will be used to assess the temperature distribution in the arm affected by lymphedema. A thermal image will be taken before and after the intervention to observe changes in inflammation and circulation in the affected area, allowing the evaluation of whether physical exercise has an effect on the reduction of temperature associated with lymphedema
Measured: 10 weeks
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
The Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire will be used to assess the functionality of the arm in the participants. This questionnaire measures limitations in daily activities related to the arm affected by lymphedema. It will be administered before and after the intervention to assess changes in mobility and functional capacity following physical exercise. In the DASH questionnaire, higher scores indicate greater disability, while lower scores indicate less disability
Measured: 10 weeks
Secondary outcomes (7)
Bicipital and Tricipital Skinfolds
Bicipital and tricipital skinfold measurements will be taken to assess the body composition and body fat percentage of the participants. These measurements will help analyze the impact of physical exercise on the reduction of body fat and potential improvements in muscle mass, especially in the area affected by lymphedema. The skinfolds will be measured in millimeters (mm), and body fat percentage will be measured in percentage (%).
Measured: 10 weeks
RS-14 Questionnaire (Resilience Scale for Adults)
The RS-14 Questionnaire (Resilience Scale for Adults) will be used to assess resilience in the participants. This questionnaire will allow us to observe whether the physical exercise intervention has an effect on the participants. In the RS-14 questionnaire, higher scores indicate greater resilience, while lower scores indicate lower resilience.
Maximum and Minimum Scores: The questionnaire consists of 14 items, each rated on a Likert scale from 1 to 7, where:
1 means "strongly disagree" 7 means "strongly agree"
The scores are summed to obtain a total score, with a scoring range of 14 to 98:
Minimum score: 14 (low resilience) Maximum score: 98 (high resilience)
Measured: 10 weeks
Trait Meta-Mood Scale (TMMS-24)
The Trait Meta-Mood Scale (TMMS-24) questionnaire will measure the level of emotional intelligence in the participants, including the perception, understanding, and regulation of emotions. It will be administered before and after the intervention to evaluate whether physical exercise influences the improvement of emotional intelligence in patients with lymphedema.
Scores: The TMMS-24 questionnaire consists of 24 items, distributed across three dimensions:
Emotional Perception Emotional Understanding Emotional Regulation
Each item is rated on a Likert scale from 1 to 5, where:
1 means "strongly disagree" 5 means "strongly agree"
Scores are summed within each dimension, and a total emotional intelligence score is obtained, with score ranges indicating different levels of emotional ability:
Low score: Indicates lower capacity in emotional perception, understanding, and regulation.
High score: Indicates greater capacity in these areas.
Measured: 10 weeks
MOS Social Support Survey (MOS-SSS)
The MOS Social Support Survey (MOS-SSS) questionnaire will be used to measure the level of social support received by the participants. This questionnaire will help identify how social support may influence the response to physical exercise.
Scores: The MOS-SSS questionnaire consists of several questions related to different dimensions of social support, such as emotional, instrumental, and relational support. Responses are rated on a Likert scale from 1 to 5, where:
1 means "None" (indicating a very low level of social support) 5 means "A lot" (indicating a very high level of social support) Scores are summed to obtain a total score, and in this case, higher scores indicate a higher level of social support, while lower scores indicate a lower level of social support.
Measured: 10 weeks
Anthropometric measurements
Changes in the participants' weight will be evaluated throughout the study. Weight will be measured in kilograms (kg), and these measurements will allow us to observe whether the physical exercise intervention has an effect on weight loss or gain in the participants. Additionally, the Body Mass Index (BMI) will be calculated for each participant, which is obtained by dividing weight (in kilograms) by height squared (in meters). The height of the participants will also be measured in meters (m) to assess changes in their overall body composition.
Measured: 10 weeks
Percentage of water
Body water percentages will be measured for each participant using validated measuring devices, such as a Tanita. This will provide a more complete picture of changes in body composition, as body water is a key indicator of hydration and overall body balance. With these measurements, it will be possible to identify variations in the distribution of fluids and other important components of the body over time.
Measured: 10 weeks
Percentage of fat
Body fat percentages will be measured for each participant using validated measuring devices, such as a Tanita. This will provide a more complete picture of changes in body composition, as body water is a key indicator of hydration and overall body balance. With these measurements, it will be possible to identify variations in the distribution of fluids and other important components of the body over time.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025
- Primary completion10 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Model description
- This is a parallel-design interventional clinical study, in which participants will be randomly assigned to two groups. The first group will receive the intervention, which consists of a supervised physical exercise program, while the second group (control group) will continue with their usual routine of daily activities without additional intervention. Both groups will be evaluated throughout the study to compare the effects of physical exercise on the improvement or prevention of post-breast cancer lymphedema
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marta Arias Crespo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de León
- Responsible party
- Sponsor-investigator, Marta Arias Crespo, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905639
- Sponsor's protocol ID
- ETICA-ULE-055-2024
- Other IDs
- No aplicable
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Exercise on Lymphedema Related to Breast Cancer: Assessment Using Thermography
- ClinicalTrials.gov ID
- NCT06905639
- Acronym / sponsor ID
- ETICA-ULE-055-2024
- Conditions
- Breast Neoplasms, Lymphedema, Thermography, Exercise
- Keywords
- Breast Neoplasms, Lymphedema, Exercise, Thermography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Marta Arias CrespoUniversity, hospital or other
- Collaborators
- Universidad de León
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 1 Apr 2025 (actual)
- 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.
Study Type: Clinical Trial
Primary Purpose: To determine whether physical exercise improves or prevents lymphedema in breast cancer patients.
Description of the Participant Population/Main Condition: The study is aimed at women who have been diagnosed with breast cancer and have experienced post-treatment lymphedema or are at risk of developing it. The target population includes adults aged 18 to 70 who have been diagnosed with this condition following their breast cancer treatment.
Main Research Questions:
Does physical exercise improve or prevent lymphedema in women with breast cancer? What are the effects of physical exercise on the reduction of arm volume affected by lymphedema? What are the effects of physical exercise on the reduction of perceived disability in the arm affected by lymphedema?
Hypothesis:
Physical exercise intervention significantly reduces lymphedema symptoms, such as arm volume. Physical exercise prevents the progression of lymphedema in women with breast cancer.
Comparison Group: Researchers will compare results between the experimental group (which will undergo physical exercise) and the control group (which will receive no intervention) to determine if physical exercise has a significant impact on the improvement or prevention of lymphedema.
Participant Tasks:
The experimental group will follow a supervised physical exercise program for a specific period. The control group will receive no intervention and will be monitored with standard follow-up care without exercise. Participants will be evaluated before and after the study period to measure the progression of lymphedema, including arm volume measurement and surface skin temperature using thermography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel-design interventional clinical study, in which participants will be randomly assigned to two groups. The first group will receive the intervention, which consists of a supervised physical exercise program, while the second group (control group) will continue with their usual routine of daily activities without additional intervention. Both groups will be evaluated throughout the study to compare the effects of physical exercise on the improvement or prevention of post-breast cancer lymphedema
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Experimental | Behavioral: Aerobic and Strength ExerciseThis arm of the study consists of participants who will receive a supervised physical exercise intervention specifically designed to improve post-breast cancer lymphedema. The program includes a combination of strength exercises and aerobic exercises, aimed at improving mobility, reducing injury, and increasing muscle strength in the arm affected by lymphedema |
| CONTROL GROUP | No intervention | –This arm of the study includes participants who will not receive any exercise intervention. They will continue with their usual daily routine and will be monitored throughout the study to compare changes in lymphedema between the intervention group and the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women over 18 years old diagnosed with breast cancer.
- Residing in the province of León.
- Not currently undergoing any physical exercise intervention at the time of the study.
- Not participating in lifestyle modification programs at the time of the study.
- Not presenting any relative or absolute sequelae from chemotherapy treatment that would pose a relative or absolute contraindication to their participation in this intervention (e.g., cardiological sequelae).
Key exclusion criteria (4 listed)
- Presenting physical and/or psychological limitations that would hinder understanding or the ability to carry out the established intervention program.
- Presenting an infection in the upper limbs or lymphangitis.
- Fluid accumulation in the breast area requiring drainage at the time of the intervention.
- Not having signed the informed consent to participate 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 |
|---|---|---|
| Aerobic and Strength ExerciseA supervised physical exercise intervention was carried out, specifically designed to improve post-breast cancer lymphedema. The program will include a combination of strength exercises and aerobic exercises, with the aim of improving mobility, reducing inflammation, and increasing muscle strength in the arm affected by lymphedema | Behavioural | INTERVENTION GROUP |
Primary outcome
Perimeters
Time frame: 10 weeks
The perimeter of the arm affected by lymphedema will be measured to assess the reduction in lymphedema volume in the participants. This measurement will be taken before and after the intervention to compare changes and determine the impact of physical exercise on inflammation and the size of the affected arm
Thermography
Time frame: 10 weeks
Thermography will be used to assess the temperature distribution in the arm affected by lymphedema. A thermal image will be taken before and after the intervention to observe changes in inflammation and circulation in the affected area, allowing the evaluation of whether physical exercise has an effect on the reduction of temperature associated with lymphedema
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time frame: 10 weeks
The Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire will be used to assess the functionality of the arm in the participants. This questionnaire measures limitations in daily activities related to the arm affected by lymphedema. It will be administered before and after the intervention to assess changes in mobility and functional capacity following physical exercise. In the DASH questionnaire, higher scores indicate greater disability, while lower scores indicate less disability
7 secondary outcomes
Bicipital and Tricipital Skinfolds
Time frame: 10 weeks
RS-14 Questionnaire (Resilience Scale for Adults)
Time frame: 10 weeks
Trait Meta-Mood Scale (TMMS-24)
Time frame: 10 weeks
MOS Social Support Survey (MOS-SSS)
Time frame: 10 weeks
Anthropometric measurements
Time frame: 10 weeks
Percentage of water
Time frame: 10 weeks
Percentage of fat
Time frame: 10 weeks
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 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and Strength Exercise in people with Breast Neoplasms and Lymphedema, run by Marta Arias Crespo 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 6 inclusion and 4 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 9 Jul 2026. 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?
Perimeters (time frame: 10 weeks). The study lists 3 primary outcomes in all. 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 9 Jul 2026.