Breast Cancer LymphedemaLinfoGYMNCT06113627
Lymphatic Response to Resistance Exercise in Breast Cancer Survivors
A study testing Resistance Therapeutic Exercise in people with Breast Cancer Lymphedema and Survivorship, run by University of Malaga at 1 site in Spain.
Trial summary
The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using variables related to the lymphatic response; 2) Study the possible relationship between… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Lymphedema, Survivorship, Lymphedema of Upper Limb
- What is being tested?
- Resistance Therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2024to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with breast cancer
- Being of legal age
- Histologically confirmed primary Breast Cancer (I-IIIA) (without the presence of metastasis) with a diagnosis in the last year
- Unilateral involvement
- Surgery for the tumor at least 6 weeks before the start of the intervention
- WHO performance status of 0 (asymptomatic, complete and ambulatory activity)
Show all 9Show fewer
- Correct understanding of Spanish
- Approval by signing the informed consent;
- Mus be considered at risk for developing LACM: 1) Have undergone surgery that includes axillary dissection; 2) Have received or are undergoing regional lymph node radiation; 3) BMI >30 kg/m2. . These patients are considered to have stage 0, subclinical or latent according to the International Society of Lymphology (ISL) , since they will not present signs or symptoms, but lymphatic transport will be altered by the treatments themselves
Who cannot join
- Women already diagnosed with LACM in stage I, II or III according to the ISL or if they present an L-Dex ratio > 10 or a difference in volume equal to or greater than 10% between both extremities
- Suffer from or have been diagnosed with any other lymphatic-venous disease in the upper extremity, such as venous insufficiency, thrombosis or lipedema;
- Suffer from conditions that prevent resistance exercise of the upper body
- Participation in regular (>1 time/week) and intense exercises involving the upper extremity during the last month
- Suffer from heart disease
- Inability to complete questionnaires;
Show all 9Show fewer
- A physical condition that prevents them from making hospital visits
- Taking any drug that may affect the lymphatic and circulatory system, such as diuretics or corticosteroids
- Women which presents some type of wound or infection on the skin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevention-Related Lymphatic Response to Resistance Exercise in Breast Cancer Survivors at Risk of Breast Cancer-Related Lymphedema
The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using variables related to the lymphatic response; 2) Study the possible relationship between changes in body composition at a local and regional level and volume changes produced by RTPE in patients at risk of suffering from BCRL.
Read the detailed description
Nowadays, research studies that confirm the safety and preventive effect of resistance or strength exercise in breast cancer-related lymphedema (BCRL) have been limited to the study of changes in variables related to the lymphatic response, such as bioimpedance spectroscopy , X-ray absorptiometry, perometry or water displacement after completion of a resistance exercise program (chronic effect).
To better understand the preventive effect of resistance exercise on the BCRL, in addition to studying the variables that are globally accepted and studied at a regional level such as the volume due to water displacement, variables that measure changes at a regional level related to body composition, such as such as echogenicity and ultrasound thickness, local tissue water and mechanical properties of tissues. Furthermore, this would allow us to detect possible changes in different body regions of the upper quadrant (upper extremity, but also breast or back), and not only taking global changes into account. On the other hand, the lymphatic response should be studied in the short term (acute effect), in the long term after an exercise program (chronic effect), as well as in the short term after the training period with possible adaptations to the lymphatic system that could explain the preventive effect.
Therefore, although there is a strong degree of scientific evidence to include therapeutic strength physical exercise as a preventive tool for LACM, the possible physiological mechanisms involved are unknown. The aim of the present project is to tudy the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using regional but also local variables related to the lymphatic response, as well as to study between changes in these variables, body composition at a local and regional level and volume changes produced by RTPE in breast cancer survivors at risk of suffering from BCRL
- Being tested
- Resistance Therapeutic Exercise
- Keywords
- Breast Cancer, Lymphedema, Early-Onset, Breast Cancer Lymphedema, Exercise Therapy, Exercise Training, Acute Exercise, Exercise Movement Techniques, Physiotherapy (Techniques)
- 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.
Resistance Therapeutic ExerciseOther
Strength exercises will be aimed at large muscle groups, such as the shoulder, chest, back and also muscle groups of the lower extremities. In the initial 2 weeks, intervention will start with low intensities of around 55-65% of 1RM, which allows to perform around 15-20 repetitions. The first week there will be performed 2 series, while in the second week it will be 3 series.
Moderate intensity in the 2nd week, corresponding to 65-75% of 1RM and allowing for around 8-12 repetitions. 3 series will be maintained throughout this period of time.In addition to the progressive change in intensity, throughout the intervention the load will be increased by 5-10% when the patient performs the exercise too easily or when they can perform more repetitions than estimated. Rest between sets will be 2-3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The intervention group will receive a total of 24 sessions of Therapeutic Resistance Exercise, distributed in 2 weekly sessions of 50 minutes during 3 months. Receives: Other: Resistance Therapeutic Exercise |
| Control group | No intervention | The control group will receive an educational booklet containing generalized mobility exercises such as frontal and lateral shoulder raises and rotations (hands to head, hands behind back). This is usually the usual treatment, since in most centers, patients are only referred for treatment of LACM when it is already established. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in volume difference between extremities (%)
The volume of both extremities will be measured to obtain the difference between both, which will be used as a relative criterion to determine the preventive effect of the intervention, determining the appearance of LACM as those cases in which the patient reaches a difference after one year of follow-up. volume equal to or greater than 10% between both extremities. It will be measured using water displacement volumetry, considered the gold standard for measuring the volume of the affected limb.
Measured: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Secondary outcomes (11)
Changes in extracelular fluid (ECF)
The EFC of the affected and contralateral side (liters, l) will be obtained. Which will allow establishing the ECF radius between the extremities. This ratios will be allowed to estimate L-Dex. The L-Dex ratio ranges between -10 and +10, taking into account the ratio between the dominant and non-dominant arms, which is equivalent to impedance ratios of 0.935 to 1.139 for the dominant arms at risk and from 0.862 to 1.066 for non-dominant arms at risk, respectively. It will be obtained through bioimpedance spectroscopy
Measured: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Changes in Percentage Water Content (PWC)
Local tissue water will be measured by bilateral tissue dielectric constant (TDC). values on the forearm and biceps using the MoistureMeterD Compact. PWC%= 100%x(TDC-1)/77.5. It will be measured on the anterior and posterior aspects of the arm and forearm, on the breast, on the lateral aspect of the shoulder and in the dorsal area.
Measured: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Changes in Thickness of the dermis and subdermis
It will be obtained through the analysis of ultrasound images. The thickness will be measured in millimeters (mm). It will be measured on the anterior and posterior aspects of the arm and forearm, on the breast, on the lateral aspect of the shoulder and in the dorsal area.
Measured: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Changes in echogenicity of the dermis and subdermis
It will be obtained through the analysis of ultrasound images. Echogenicity or echointensity refers to the average value obtained from a histogram generated from an 8-bit gray scale. This analysis does not have units of measurement, but provides a numerical value between 0 and 255. It will be measured on the anterior and posterior aspects of the arm and forearm, on the breast, on the lateral aspect of the shoulder and in the dorsal area.
Measured: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Changes in elastic properties of tissues.
It will be measured with a MyotonPRO portable device (Myoton AS, Estonia), whose probe will be placed on the surface of the skin and produce a mechanical stimulus that will provide five parameters: Tone (Hz), Dynamic stiffness (N/m), Elasticity (unit relative), Relaxation time (ms) and Fluency (relative unit). It will be measured on the anterior and posterior aspects of the arm and forearm, on the breast, on the lateral aspect of the shoulder and in the dorsal area.
Measured: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Quality of life (QoL)
it will be measured using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire (EORTC QLQ-BR23). This is an EORTC QLQ-C30 breast cancer module that contains 23 items that assess disease symptoms, treatment side effects, body image, sexual functioning, and future outlook. All items are rated on a 4-point scale (1, not at all to very much). Higher scores represent better functioning and higher symptom scores show greater problems. Cronbach's α ranged from 0.46 to 0.94, showing high reliability.
Measured: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Active Range of Movement (AROM, degrees)
Abduction and flexion of the shoulder joint complex will be measured. It will be measured in a sitting position, ensuring that there is no movement of the trunk, using a digital inclinometer.
Measured: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Grip strength (kg)
It will be measured using the Jamar Hydraulic Hand dynamometer. All participants will sit in a chair without armrests, with their feet on the floor and their back straight, holding the dynamometer with their dominant arm. The elbow was flexed at 90° and the wrist was in a neutral position (0°). Maximum isometric voluntary contractions will be performed for 5 seconds. The force will be expressed in kg. Of the 3 measurements carried out, the peak force will be recorded in units of Newtons (N) or in Kilograms (Kg), obtained from both extremities
Measured: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
Perceived shoulder function (%)
It will be measured using the Shoulder Pain and Disability Index (SPADI) questionnaire. SPADI consists of 13 items that are distributed in two different subscales: one related to pain, which contains 5 items, and another related to disability, which contains 8 items. Scoring of items in both subscales is on a scale ranging from 0 (indicating absence of pain or disability) to 10 (representing the worst pain imaginable or such significant difficulty in performing tasks that help is needed). The higher the score on each subscale, the greater the pain intensity and the greater the disability experienced by the individual evaluated.
Measured: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
Symptoms Related to Lymphedema
It will be measured using the Spanish version of the Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) questionnaire.This questionnaire consists of 2 parts: Part 1 is made up of 24 items and evaluates the symptoms of LACM using a Likert scale from 0 (absence of a certain symptom) to 4 (greater severity of a certain symptom); Part 2 is made up of 32 items that evaluate the symptom of discomfort, that is, the negative impact and suffering evoked by the experience of lymphedema. Each part is calculated with the sum of all the responses, and in turn they can be added together to obtain a total score
Measured: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
Fear-Avoidance
It will be measured using the Spanish version of Fear-Avoidance component scale (FACS). The FACS contains 20 separate items that are scored from 0 ("completely disagree") to 5 ("completely agree"), with a total possible score of 100. Five severity levels are available for clinical interpretation: subclinical (0-20), mild (21-40), moderate (41-60), severe (61-80), and ex- treme (81-100). This questionnaire has been validated in breast cancer population, showing good psychometric properties.
Measured: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study startAug 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Roldán-Jiménez, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113627
- Sponsor's protocol ID
- 10-2023
- Acronym
- LinfoGYM
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roldán-Jiménez C. What are the physiologic effects of Resistance Exercise behind breast cancer-related lymphedema prevention? Medical Hypotheses Volume 171, February 2023, 111022. https://doi.org/10.1016/j.mehy.2023.111022
Roldan-Jimenez C, Pajares B, Ruiz-Medina S, Trinidad-Fernandez M, Gonzalez-Sanchez M, Ribelles N, Garcia-Almeida JM, Rios-Lopez MJ, Alba E, Cuesta-Vargas AI. Design and implementation of a standard care programme of therapeutic exercise and education for breast cancer survivors. Support Care Cancer. 2022 Feb;30(2):1243-1251. doi: 10.1007/s00520-021-06470-9. Epub 2021 Aug 31.
PubMed 34463835Gutierrez-Sanchez D, Pajares-Hachero BI, Trinidad-Fernandez M, Escriche-Escuder A, Iglesias-Campos M, Bermejo-Perez MJ, Alba-Conejo E, Roldan-Jimenez C, Cuesta-Vargas A. The Benefits of a Therapeutic Exercise and Educational Intervention Program on Central Sensitization Symptoms and Pain-Related Fear Avoidance in Breast Cancer Survivors. Pain Manag Nurs. 2022 Aug;23(4):467-472. doi: 10.1016/j.pmn.2022.01.003. Epub 2022 Mar 9.
PubMed 35277360Roldan-Jimenez C, Martin-Martin J, Pajares B, Ribelles N, Alba E, Cuesta-Vargas AI. Factors associated with upper limb function in breast cancer survivors. PM R. 2023 Feb;15(2):151-156. doi: 10.1002/pmrj.12731. Epub 2021 Nov 23.
PubMed 34713595Escriche-Escuder A, Trinidad-Fernandez M, Pajares B, Iglesias-Campos M, Alba E, Cuesta-Vargas AI, Roldan-Jimenez C. Ultrasound use in metastatic breast cancer to measure body composition changes following an exercise intervention. Sci Rep. 2021 Apr 23;11(1):8858. doi: 10.1038/s41598-021-88375-5.
PubMed 33893370Davies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087.
PubMed 32589208Wang L, Shi YX, Wang TT, Chen KX, Shang SM. Breast cancer-related lymphoedema and resistance exercise: An evidence-based review of guidelines, consensus statements and systematic reviews. J Clin Nurs. 2023 May;32(9-10):2208-2227. doi: 10.1111/jocn.16437. Epub 2022 Jul 27.
PubMed 35894167
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention-Related Lymphatic Response to Resistance Exercise in Breast Cancer Survivors at Risk of Breast Cancer-Related Lymphedema
- ClinicalTrials.gov ID
- NCT06113627
- Acronym / sponsor ID
- LinfoGYM / 10-2023
- Keywords
- Breast Cancer, Lymphedema, Early-Onset, Breast Cancer Lymphedema, Exercise Therapy, Exercise Training, Acute Exercise, Exercise Movement Techniques, Physiotherapy (Techniques)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 2 Nov 2023 (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.
The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using variables related to the lymphatic response; 2) Study the possible relationship between changes in body composition at a local and regional level and volume changes produced by RTPE in patients at risk of suffering from BCRL.
Detailed description
Nowadays, research studies that confirm the safety and preventive effect of resistance or strength exercise in breast cancer-related lymphedema (BCRL) have been limited to the study of changes in variables related to the lymphatic response, such as bioimpedance spectroscopy , X-ray absorptiometry, perometry or water displacement after completion of a resistance exercise program (chronic effect).
To better understand the preventive effect of resistance exercise on the BCRL, in addition to studying the variables that are globally accepted and studied at a regional level such as the volume due to water displacement, variables that measure changes at a regional level related to body composition, such as such as echogenicity and ultrasound thickness, local tissue water and mechanical properties of tissues. Furthermore, this would allow us to detect possible changes in different body regions of the upper quadrant (upper extremity, but also breast or back), and not only taking global changes into account. On the other hand, the lymphatic response should be studied in the short term (acute effect), in the long term after an exercise program (chronic effect), as well as in the short term after the training period with possible adaptations to the lymphatic system that could explain the preventive effect.
Therefore, although there is a strong degree of scientific evidence to include therapeutic strength physical exercise as a preventive tool for LACM, the possible physiological mechanisms involved are unknown. The aim of the present project is to tudy the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using regional but also local variables related to the lymphatic response, as well as to study between changes in these variables, body composition at a local and regional level and volume changes produced by RTPE in breast cancer survivors at risk of suffering from BCRL
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Resistance Therapeutic ExerciseThe intervention group will receive a total of 24 sessions of Therapeutic Resistance Exercise, distributed in 2 weekly sessions of 50 minutes during 3 months. |
| Control group | No intervention | –The control group will receive an educational booklet containing generalized mobility exercises such as frontal and lateral shoulder raises and rotations (hands to head, hands behind back). This is usually the usual treatment, since in most centers, patients are only referred for treatment of LACM when it is already established. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women diagnosed with breast cancer
- Being of legal age
- Histologically confirmed primary Breast Cancer (I-IIIA) (without the presence of metastasis) with a diagnosis in the last year
- Unilateral involvement
- Surgery for the tumor at least 6 weeks before the start of the intervention
Key exclusion criteria (9 listed)
- Women already diagnosed with LACM in stage I, II or III according to the ISL or if they present an L-Dex ratio > 10 or a difference in volume equal to or greater than 10% between both extremities
- Suffer from or have been diagnosed with any other lymphatic-venous disease in the upper extremity, such as venous insufficiency, thrombosis or lipedema;
- Suffer from conditions that prevent resistance exercise of the upper body
- Participation in regular (>1 time/week) and intense exercises involving the upper extremity during the last month
- Suffer from heart disease
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 |
|---|---|---|
| Resistance Therapeutic ExerciseStrength exercises will be aimed at large muscle groups, such as the shoulder, chest, back and also muscle groups of the lower extremities. In the initial 2 weeks, intervention will start with low intensities of around 55-65% of 1RM, which allows to perform around 15-20 repetitions. The first week there will be performed 2 series, while in the second week it will be 3 series. Moderate intensity in the 2nd week, corresponding to 65-75% of 1RM and allowing for around 8-12 repetitions. 3 series will be maintained throughout this period of time.In addition to the progressive change in intensity, throughout the intervention the load will be increased by 5-10% when the patient performs the exercise too easily or when they can perform more repetitions than estimated. Rest between sets will be 2-3 minutes. | Other | Exercise group |
Primary outcome
Changes in volume difference between extremities (%)
Time frame: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
The volume of both extremities will be measured to obtain the difference between both, which will be used as a relative criterion to determine the preventive effect of the intervention, determining the appearance of LACM as those cases in which the patient reaches a difference after one year of follow-up. volume equal to or greater than 10% between both extremities. It will be measured using water displacement volumetry, considered the gold standard for measuring the volume of the affected limb.
11 secondary outcomes
Changes in extracelular fluid (ECF)
Time frame: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Changes in Percentage Water Content (PWC)
Time frame: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Changes in Thickness of the dermis and subdermis
Time frame: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Changes in echogenicity of the dermis and subdermis
Time frame: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Changes in elastic properties of tissues.
Time frame: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Quality of life (QoL)
Time frame: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Active Range of Movement (AROM, degrees)
Time frame: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Grip strength (kg)
Time frame: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
Perceived shoulder function (%)
Time frame: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
Symptoms Related to Lymphedema
Time frame: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
Fear-Avoidance
Time frame: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- BackgroundRoldán-Jiménez C. What are the physiologic effects of Resistance Exercise behind breast cancer-related lymphedema prevention? Medical Hypotheses Volume 171, February 2023, 111022. https://doi.org/10.1016/j.mehy.2023.111022
- Background: PubMed 34463835Roldan-Jimenez C, Pajares B, Ruiz-Medina S, Trinidad-Fernandez M, Gonzalez-Sanchez M, Ribelles N, Garcia-Almeida JM, Rios-Lopez MJ, Alba E, Cuesta-Vargas AI. Design and implementation of a standard care programme of therapeutic exercise and education for breast cancer survivors. Support Care Cancer. 2022 Feb;30(2):1243-1251. doi: 10.1007/s00520-021-06470-9. Epub 2021 Aug 31.
- Background: PubMed 35277360Gutierrez-Sanchez D, Pajares-Hachero BI, Trinidad-Fernandez M, Escriche-Escuder A, Iglesias-Campos M, Bermejo-Perez MJ, Alba-Conejo E, Roldan-Jimenez C, Cuesta-Vargas A. The Benefits of a Therapeutic Exercise and Educational Intervention Program on Central Sensitization Symptoms and Pain-Related Fear Avoidance in Breast Cancer Survivors. Pain Manag Nurs. 2022 Aug;23(4):467-472. doi: 10.1016/j.pmn.2022.01.003. Epub 2022 Mar 9.
- Background: PubMed 34713595Roldan-Jimenez C, Martin-Martin J, Pajares B, Ribelles N, Alba E, Cuesta-Vargas AI. Factors associated with upper limb function in breast cancer survivors. PM R. 2023 Feb;15(2):151-156. doi: 10.1002/pmrj.12731. Epub 2021 Nov 23.
- Background: PubMed 33893370Escriche-Escuder A, Trinidad-Fernandez M, Pajares B, Iglesias-Campos M, Alba E, Cuesta-Vargas AI, Roldan-Jimenez C. Ultrasound use in metastatic breast cancer to measure body composition changes following an exercise intervention. Sci Rep. 2021 Apr 23;11(1):8858. doi: 10.1038/s41598-021-88375-5.
- Background: PubMed 32589208Davies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087.
- Background: PubMed 35894167Wang L, Shi YX, Wang TT, Chen KX, Shang SM. Breast cancer-related lymphoedema and resistance exercise: An evidence-based review of guidelines, consensus statements and systematic reviews. J Clin Nurs. 2023 May;32(9-10):2208-2227. doi: 10.1111/jocn.16437. Epub 2022 Jul 27.
- 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.
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 Resistance Therapeutic Exercise in people with Breast Cancer Lymphedema and Survivorship, run by University of Malaga 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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Nov 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in volume difference between extremities (%) (time frame: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year). 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 NCT06113627, which also lists 7 linked publications.
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 2 Nov 2023.