Breast Cancer Related LymphedemaNCT06491654
Physiotherapy Program Impact on Breast Cancer-Related Lymphedema
A study testing 12-week supervised exercise in people with Breast Cancer Related Lymphedema, run by European University Miguel de Cervantes at 1 site in Spain.
Trial summary
Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection and regional lymph node radiation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Related Lymphedema
- What is being tested?
- 12-week supervised exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 11 Mar 2024to 10 Oct 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Breast cancer survivors who have completed treatment (chemotherapy, surgery, and/or radiotherapy) at least 6 months prior to randomization for the trial.
- Patients diagnosed with unilateral stage I or II BCRL as established by the International Society of Lymphology Congress Working Group in 2020, or patients at risk of developing unilateral BCRL (who have received radiotherapy in the axillary region/radical mastectomy/modified radical mastectomy and lymph node dissection/breast surgery and sentinel lymph node biopsy).
- Age between 18 and 65 years.
- Voluntary participation in the study and informed consent.
Who cannot join
- Recent surgery (<3 months) or planned surgery during the study period.
- Patients with cognitive impairment.
- Patients with bilateral lymphedema.
- Health problems or illnesses that prevent them from participating in the intervention.
- Other serious conditions that may affect their HRQOL (Health-Related Quality of Life).
Trial locations and contacts
1 site in 1 country.
Spain1 site
European University Miguel of Cervantes
Valladolid, Castille and León, 47012
About this study
Official title: Effect of a Physiotherapy Program Based on Concurrent Strength and Moderate-to-high Intensity Aerobic Exercise Training, Along With Cohesive Bandaging, in Women With Breast Cancer-related Lymphedema.
Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection and regional lymph node radiation. The main objective of the present clinical trial is to determine the effectiveness of moderate-high intensity strength training in combination with an aerobic exercise protocol and the application of cohesive compression bandaging in subjects with or at risk for BCRL and to analyze the acute responses of the molecular, functional and clinical profile of patients with BCRL or at risk after two sessions of intervention. To compare proteomic analysis of patients or at risk with healthy controls and to assess the adaptations produced after 12 weeks of exercise intervention and over a 12-week post-intervention period in patients with BCRL or at risk.
Read the detailed description
Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection andregional lymph node radiation. Clinically, it can cause pain, swelling and a decrease in the functionality of those patients who suffer from it. Moderate-high intensity strength exercise, in combination with aerobic exercise and a cohesive compressive bandage, could minimize the associated symptomatology and clinical symptoms, as well as improve various biological parameters related to tumor progression and increase the functionality of patients. Likewise, the study of the long-term effects of the treatment will make it possible to determine the chronic adaptations generated by exercise.
The intervention will consist of concurrent training (strength and aerobic exercise) for all patients, whether they have BCRL or are at risk. Also, patients with BCRL will have cohesive bandaging applied at the end of the exercise session. The main objective of this study is to determine the benefits that moderate-high intensity strength training, in combination with an aerobic exercise protocol and, together with the application of a compressive bandage, generates on patients suffering from BCRL or at risk of suffering it. Through this investigation, we seek to analyze the impact of the intervention on various clinical, functional, and molecular factors. Likewise, healthy controls participants will participate in two exercise interventions and functional and molecular adaptations will be analyzed.
- Conditions
- Breast Cancer Related Lymphedema
- Being tested
- 12-week supervised exercise
- Keywords
- High-intensity functional training, Breast cancer, Lymphedema, Compression bandage, Strength exercise, Quality of life
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week supervised exerciseOther
During the study period (1 week for acute effects, 12 weeks for chronic effects), there will be 8 sessions per month, lasting 40-60 minutes each, with 2 sessions per week on alternate days, totaling 24 sessions. Each session includes: (1) warm-up (mobility exercises); (2) training: 5-min warm-up, followed by 15-min moderate-to-high intensity circuit of 7 functional global exercises with 10 reps each at a perceived exertion effort (RPE) of 5-7 on a scale of 1 to 10; (3) Aerobic exercise: starting at 15 mins, increasing by 5 mins biweekly to 30 mins by week 7; (4) Cool-down (general mobility); (5) Application of cohesive compressive bandage on the affected upper limb, worn for 2 hours post-session, removed at home. Participants may add a cotton bandage and finger bandage if needed.
| Study group | Role | What they receive |
|---|---|---|
| Lymphedema experimental | Experimental | Subjects belonging to this group perform a 12-week supervised exercise. The patients will follow a moderate-to-high intensity strength exercise protocol, along with the application of a cohesive bandage (bandage will only be applied in subjects with Breast Cancer-Related Lymphedema, BCRL, and not in patients at risk). Receives: Other: 12-week supervised exercise |
| Healthy control | No intervention | Subjects belonging to this group perform a 1-week supervised exercise, following the same training protocol as experimental group (arm 1). This group will not receive cohesive compressive bandage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular variables: proteome.
Venous blood samples are collected from the antecubital vein and kept at 4°C until preparation to avoid clotting and minimise protein degradation. Samples are centrifuged at 1500 g for 10 minutes at 4°C. Subsequently, the plasma is centrifuged at 2500g for 15 minutes at 4°C.
Samples shall are stored at -80°C for subsequent analysis and only one freeze-thaw cycle shall be allowed. All samples shall are prepared within 1 hour of sample collection and show no signs of haemolysis.
Likewise, a tear sample (5-15 µl) is taken from each eye, using a microcapillary for each eye. The sample is taken non-traumatically from the outer third of the tear meniscus. Samples are split and used both for cytokine analysis using a Luminex and frozen at -80°C for analysis.
The protein concentration will be analyzed.
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: total session workload and total workload.
The magnitude of the load is adjusted every 3 weeks to increase the intensity and volume of exercise.
The number of repetition maxes and the peak force of these repetitions are recorded. Depending on the results obtained, the load is adjusted to 80% of the number of maximum repetitions or the intensity of the assigned rubber will be increased (when the number of repetitions is close to 20).
The volume of aerobic exercise increases by 5 minutes every 2 weeks up to a maximum of 30 minutes.
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: physical activity levels
Physical activity levels are recorded using an International Physical Activity Questionnaire (IPAQ). The results of the IPAQ indicate the METs/week of physical activity to classify the physical activity levels of each participant. The weighted MET-minutes per week (MET·min·wk-1) are calculated as duration × frequency per week × MET intensity, which are summed across activity domains to produce a weighted estimate of total physical activity from all reported activities per week (MET·min·wk-1).
The items are structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity.
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: upper limb strength.
To assess strength, a unilateral isometric test (chest press) is performed with a force sensor and 3 repetitions are performed with two minutes rest between repetitions for each upper limb. The peak force (N) of each isometric contraction is recorded.
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: lower limb strength.
To assess strength, an isometric test (squat) is performed with a force sensor and 3 repetitions are performed with two minutes rest between repetitions. The peak force (N) of each isometric contraction is recorded.
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: manual grip strength.
To assess strength, a manual grip strength test is performed with a hand-held dynamometer and 3 repetitions with three minutes rest between repetitions are performed for each upper limb. The peak force (kg) of each isometric contraction is recorded.
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: endurance and effort intensity
Changes in measurements by a cycloergometer. Endurance and effort intensity is meadured in watts by a cycloergometer.
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: blood pressure
Changes in systolic pressure and diastolic pressure in mm Hg.
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: gas consumption analysis
Changes in oxygen consumption (VO2) and carbon dioxide production (CO2).
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: endurance and effort intensity.
Changes in endurance and effort intensity in watts (W) measurements by a cycloergometer.
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: Heart rate.
Changes in heart rate. Polar H10 Heart Rate Monitor with Chest Strap
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: Rate of perceived exertion (RPE)
Changes in rate of perceived exertion (RPE). Using a numeric rating scale (NRS) of perceived exertion from 0 to 10 (known as the RPE CR-10 scale).
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: Electrical activity released by muscles by electromyography with surface electrodes to analyze muscle response.
Changes in microvolts (µV).
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Functional variables: Electrical activity released by muscles by electromyography with surface electrodes to analyze electrical activity.
Changes in EMG frequency (Hz).
Measured: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Health-related quality of life by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B and FACT-b+4).
The total FACT-G score consists of the sum of the four subdomains, ranging from 0 to 108. A higher score indicates a better Health-related quality of life (HRQoL).
Measured: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
Health-related quality of life by Upper Limb Lymphedema (ULL)-27 Questionnaire.
Upper Limb Lymphedema (ULL)-27:
It is a scale that can describe all symptoms in one form, can provide a holistic approach, is easy to use, and can evaluate their ability to perform common functional activities in patients with Breast Cancer Related Lymphedema.
The scale consists of 27 questions with physical, psychological, and social dimensions. 5-point Likert scoring scale (1 = strongly disagree, 5 = strongly agree) is used. The first 15 questions are on the physical dimension (min 15 and max 75 points), the questions between 16 and 22 on social dimension (min 7 and max 35 points), and the questions between 23 and 27 evaluate the social dimension (min 5 and max 25 points) of the individual. The total score of 27 questions is calculated for the global score. The lowest score is 27 and the highest score is 135 points. The high score of the scale shows that it affects the quality of life of the individual badly.
Measured: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire.
Changes in total punctuation of questionnaire. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The items ask about the degree of difficulty in performing different physical activities because of the arm, shoulder, or hand problem (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (5 items), as well as the problem's impact on social activities, work, sleep, and self-image (4 items). Each item has five response options. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability). The score for the disability/symptom scale is called the DASH score.
Measured: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
Numeric Rating Scale (NRS).
Numeric Rating Scale (NRS) typically consists of a series of numbers with verbal anchors representing the entire possible range of pain intensity. Generally, patients rate their pain from 0 to 10, from 0 to 20, or from 0 to 100. Zero represents "no pain," whereas 10, 20, or 100 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain").
Measured: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
Clinical variables: Blood pressure.
Changes in mean arterial pressure, systolic and diastolic pressure.
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Arm-ankle index
Changes in the measurements.
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Flow-mediated dilation of the brachial artery.
Changes in the measurements.
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Ankle-brachial index.
Changes in the measurements.
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Arm volume.
Changes in the measurements. Arm volume is calculated by making circumferences along the arm and converting them into volume (ml) using a truncated cone formula.
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Range of joint motion.
Changes in measurements (mean). The range of joint movement is calculated using a goniometer and the degrees of mobility are analysed.
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Heart rate variability.
Changes in heart rate monitoring. Heart rate variability is assessed by using a pulsometer and changes in variability are measured in the time interval between heartbeats.
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Ultrasound assessment of lymphedema.
Ultrasound assessment determines the thickness of subcutaneous and muscle tissue at different points of the upper limb: changes in thickness (in cm) will be assessed 10 cm distal and proximal to the elbow at the anterior, medial, posterior and lateral levels.
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Echocardiographic measurement.
Changes in functional cardiac modifications (left ventricular ejection fraction).
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Bone mineral density.
Changes in measurements by DXA (Dual-energy X-ray Absorptiometry).
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Clinical variables: Body composition.
Changes in measurements by BMI (Body Mass Index) in kg/m^2.
Measured: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start11 Mar 2024
- Primary completion20 Sep 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Why it stopped: The study was discontinued because the estimated sample size necessary to obtain adequate statistical power was not reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Related LymphedemaStudies 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
- Prospective single-center randomized clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Miguel de Cervantes
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid
- Responsible party
- Sponsor
- Investigators
- Alejandro Santos Lozano, PhD, Principal investigator, Universidad Europea Miguel de Cervantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491654
- Sponsor's protocol ID
- PI-DOC005-BCRL
- Status last verified
- Jun 2025
- First submitted
- 22 Feb 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Executive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020;53(1):3-19.
PubMed 32521126
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Physiotherapy Program Based on Concurrent Strength and Moderate-to-high Intensity Aerobic Exercise Training, Along With Cohesive Bandaging, in Women With Breast Cancer-related Lymphedema.
- ClinicalTrials.gov ID
- NCT06491654
- Acronym / sponsor ID
- PI-DOC005-BCRL
- Conditions
- Breast Cancer Related Lymphedema
- Keywords
- High-intensity functional training, Breast cancer, Lymphedema, Compression bandage, Strength exercise, Quality of life
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study was discontinued because the estimated sample size necessary to obtain adequate statistical power was not reached.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- European University Miguel de CervantesUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection and regional lymph node radiation. The main objective of the present clinical trial is to determine the effectiveness of moderate-high intensity strength training in combination with an aerobic exercise protocol and the application of cohesive compression bandaging in subjects with or at risk for BCRL and to analyze the acute responses of the molecular, functional and clinical profile of patients with BCRL or at risk after two sessions of intervention. To compare proteomic analysis of patients or at risk with healthy controls and to assess the adaptations produced after 12 weeks of exercise intervention and over a 12-week post-intervention period in patients with BCRL or at risk.
Detailed description
Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection andregional lymph node radiation. Clinically, it can cause pain, swelling and a decrease in the functionality of those patients who suffer from it. Moderate-high intensity strength exercise, in combination with aerobic exercise and a cohesive compressive bandage, could minimize the associated symptomatology and clinical symptoms, as well as improve various biological parameters related to tumor progression and increase the functionality of patients. Likewise, the study of the long-term effects of the treatment will make it possible to determine the chronic adaptations generated by exercise.
The intervention will consist of concurrent training (strength and aerobic exercise) for all patients, whether they have BCRL or are at risk. Also, patients with BCRL will have cohesive bandaging applied at the end of the exercise session. The main objective of this study is to determine the benefits that moderate-high intensity strength training, in combination with an aerobic exercise protocol and, together with the application of a compressive bandage, generates on patients suffering from BCRL or at risk of suffering it. Through this investigation, we seek to analyze the impact of the intervention on various clinical, functional, and molecular factors. Likewise, healthy controls participants will participate in two exercise interventions and functional and molecular adaptations will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective single-center randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Lymphedema experimental | Experimental | Other: 12-week supervised exerciseSubjects belonging to this group perform a 12-week supervised exercise. The patients will follow a moderate-to-high intensity strength exercise protocol, along with the application of a cohesive bandage (bandage will only be applied in subjects with Breast Cancer-Related Lymphedema, BCRL, and not in patients at risk). |
| Healthy control | No intervention | –Subjects belonging to this group perform a 1-week supervised exercise, following the same training protocol as experimental group (arm 1). This group will not receive cohesive compressive bandage. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer survivors who have completed treatment (chemotherapy, surgery, and/or radiotherapy) at least 6 months prior to randomization for the trial.
- Patients diagnosed with unilateral stage I or II BCRL as established by the International Society of Lymphology Congress Working Group in 2020, or patients at risk of developing unilateral BCRL (who have received radiotherapy in the axillary region/radical mastectomy/modified radical mastectomy and lymph node dissection/breast surgery and sentinel lymph node biopsy).
- Age between 18 and 65 years.
- Voluntary participation in the study and informed consent.
Key exclusion criteria (5 listed)
- Recent surgery (<3 months) or planned surgery during the study period.
- Patients with cognitive impairment.
- Patients with bilateral lymphedema.
- Health problems or illnesses that prevent them from participating in the intervention.
- Other serious conditions that may affect their HRQOL (Health-Related Quality of Life).
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 |
|---|---|---|
| 12-week supervised exerciseDuring the study period (1 week for acute effects, 12 weeks for chronic effects), there will be 8 sessions per month, lasting 40-60 minutes each, with 2 sessions per week on alternate days, totaling 24 sessions. Each session includes: (1) warm-up (mobility exercises); (2) training: 5-min warm-up, followed by 15-min moderate-to-high intensity circuit of 7 functional global exercises with 10 reps each at a perceived exertion effort (RPE) of 5-7 on a scale of 1 to 10; (3) Aerobic exercise: starting at 15 mins, increasing by 5 mins biweekly to 30 mins by week 7; (4) Cool-down (general mobility); (5) Application of cohesive compressive bandage on the affected upper limb, worn for 2 hours post-session, removed at home. Participants may add a cotton bandage and finger bandage if needed. | Other | Lymphedema experimental |
Primary outcome
Molecular variables: proteome.
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Venous blood samples are collected from the antecubital vein and kept at 4°C until preparation to avoid clotting and minimise protein degradation. Samples are centrifuged at 1500 g for 10 minutes at 4°C. Subsequently, the plasma is centrifuged at 2500g for 15 minutes at 4°C. Samples shall are stored at -80°C for subsequent analysis and only one freeze-thaw cycle shall be allowed. All samples shall are prepared within 1 hour of sample collection and show no signs of haemolysis. Likewise, a tear sample (5-15 µl) is taken from each eye, using a microcapillary for each eye. The sample is taken non-traumatically from the outer third of the tear meniscus. Samples are split and used both for cytokine analysis using a Luminex and frozen at -80°C for analysis. The protein concentration will be analyzed.
Functional variables: total session workload and total workload.
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
The magnitude of the load is adjusted every 3 weeks to increase the intensity and volume of exercise. The number of repetition maxes and the peak force of these repetitions are recorded. Depending on the results obtained, the load is adjusted to 80% of the number of maximum repetitions or the intensity of the assigned rubber will be increased (when the number of repetitions is close to 20). The volume of aerobic exercise increases by 5 minutes every 2 weeks up to a maximum of 30 minutes.
Functional variables: physical activity levels
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Physical activity levels are recorded using an International Physical Activity Questionnaire (IPAQ). The results of the IPAQ indicate the METs/week of physical activity to classify the physical activity levels of each participant. The weighted MET-minutes per week (MET·min·wk-1) are calculated as duration × frequency per week × MET intensity, which are summed across activity domains to produce a weighted estimate of total physical activity from all reported activities per week (MET·min·wk-1). The items are structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity.
Functional variables: upper limb strength.
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
To assess strength, a unilateral isometric test (chest press) is performed with a force sensor and 3 repetitions are performed with two minutes rest between repetitions for each upper limb. The peak force (N) of each isometric contraction is recorded.
Functional variables: lower limb strength.
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
To assess strength, an isometric test (squat) is performed with a force sensor and 3 repetitions are performed with two minutes rest between repetitions. The peak force (N) of each isometric contraction is recorded.
Functional variables: manual grip strength.
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
To assess strength, a manual grip strength test is performed with a hand-held dynamometer and 3 repetitions with three minutes rest between repetitions are performed for each upper limb. The peak force (kg) of each isometric contraction is recorded.
Functional variables: endurance and effort intensity
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Changes in measurements by a cycloergometer. Endurance and effort intensity is meadured in watts by a cycloergometer.
Functional variables: blood pressure
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Changes in systolic pressure and diastolic pressure in mm Hg.
Functional variables: gas consumption analysis
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Changes in oxygen consumption (VO2) and carbon dioxide production (CO2).
Functional variables: endurance and effort intensity.
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Changes in endurance and effort intensity in watts (W) measurements by a cycloergometer.
Functional variables: Heart rate.
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Changes in heart rate. Polar H10 Heart Rate Monitor with Chest Strap
Functional variables: Rate of perceived exertion (RPE)
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Changes in rate of perceived exertion (RPE). Using a numeric rating scale (NRS) of perceived exertion from 0 to 10 (known as the RPE CR-10 scale).
Functional variables: Electrical activity released by muscles by electromyography with surface electrodes to analyze muscle response.
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Changes in microvolts (µV).
Functional variables: Electrical activity released by muscles by electromyography with surface electrodes to analyze electrical activity.
Time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
Changes in EMG frequency (Hz).
Health-related quality of life by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B and FACT-b+4).
Time frame: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
The total FACT-G score consists of the sum of the four subdomains, ranging from 0 to 108. A higher score indicates a better Health-related quality of life (HRQoL).
Health-related quality of life by Upper Limb Lymphedema (ULL)-27 Questionnaire.
Time frame: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
Upper Limb Lymphedema (ULL)-27: It is a scale that can describe all symptoms in one form, can provide a holistic approach, is easy to use, and can evaluate their ability to perform common functional activities in patients with Breast Cancer Related Lymphedema. The scale consists of 27 questions with physical, psychological, and social dimensions. 5-point Likert scoring scale (1 = strongly disagree, 5 = strongly agree) is used. The first 15 questions are on the physical dimension (min 15 and max 75 points), the questions between 16 and 22 on social dimension (min 7 and max 35 points), and the questions between 23 and 27 evaluate the social dimension (min 5 and max 25 points) of the individual. The total score of 27 questions is calculated for the global score. The lowest score is 27 and the highest score is 135 points. The high score of the scale shows that it affects the quality of life of the individual badly.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire.
Time frame: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
Changes in total punctuation of questionnaire. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The items ask about the degree of difficulty in performing different physical activities because of the arm, shoulder, or hand problem (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (5 items), as well as the problem's impact on social activities, work, sleep, and self-image (4 items). Each item has five response options. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability). The score for the disability/symptom scale is called the DASH score.
Numeric Rating Scale (NRS).
Time frame: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
Numeric Rating Scale (NRS) typically consists of a series of numbers with verbal anchors representing the entire possible range of pain intensity. Generally, patients rate their pain from 0 to 10, from 0 to 20, or from 0 to 100. Zero represents "no pain," whereas 10, 20, or 100 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain").
Clinical variables: Blood pressure.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in mean arterial pressure, systolic and diastolic pressure.
Clinical variables: Arm-ankle index
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in the measurements.
Clinical variables: Flow-mediated dilation of the brachial artery.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in the measurements.
Clinical variables: Ankle-brachial index.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in the measurements.
Clinical variables: Arm volume.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in the measurements. Arm volume is calculated by making circumferences along the arm and converting them into volume (ml) using a truncated cone formula.
Clinical variables: Range of joint motion.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in measurements (mean). The range of joint movement is calculated using a goniometer and the degrees of mobility are analysed.
Clinical variables: Heart rate variability.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in heart rate monitoring. Heart rate variability is assessed by using a pulsometer and changes in variability are measured in the time interval between heartbeats.
Clinical variables: Ultrasound assessment of lymphedema.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Ultrasound assessment determines the thickness of subcutaneous and muscle tissue at different points of the upper limb: changes in thickness (in cm) will be assessed 10 cm distal and proximal to the elbow at the anterior, medial, posterior and lateral levels.
Clinical variables: Echocardiographic measurement.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in functional cardiac modifications (left ventricular ejection fraction).
Clinical variables: Bone mineral density.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in measurements by DXA (Dual-energy X-ray Absorptiometry).
Clinical variables: Body composition.
Time frame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Changes in measurements by BMI (Body Mass Index) in kg/m^2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 32521126Executive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020;53(1):3-19.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Related Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Lymphedema, Breast Cancer
Recruiting
EFFECT OF ESWT ON BREAST-CANCER RELATED LYMPHEDEMA
Breast Cancer Related Lymphedema
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.
Alejandro Santos Lozano, PhD principal investigator
Universidad Europea Miguel de Cervantes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week supervised exercise in people with Breast Cancer Related Lymphedema, run by European University Miguel de Cervantes 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 4 inclusion and 5 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: paused, as of the sponsor's last update on 11 Jun 2025. 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?
Results are not available in the source record.
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?
Molecular variables: proteome. (time frame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06491654, which also lists 1 linked publication.
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 11 Jun 2025.