Clinical trial NCT06905639: Impact of Physical Exercise on Lymphedema Related to Breast Cancer: Assessment Using Thermography
Official title: Impact of Physical Exercise on Lymphedema Related to Breast Cancer: Assessment Using Thermography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lymphedema
Thermography
Exercise
Keywords: Breast Neoplasms
Lymphedema
Exercise
Thermography
Lead sponsor: Universidad de León
Sponsor class: OTHER
Collaborators: name: University of Leon
First posted: 2025-04-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Perimeters
timeFrame: 10 weeks
measure: Thermography
timeFrame: 10 weeks
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
timeFrame: 10 weeks
Secondary outcomes:
measure: Bicipital and Tricipital Skinfolds
timeFrame: 10 weeks
measure: RS-14 Questionnaire (Resilience Scale for Adults)
timeFrame: 10 weeks
measure: Trait Meta-Mood Scale (TMMS-24)
timeFrame: 10 weeks
measure: MOS Social Support Survey (MOS-SSS)
timeFrame: 10 weeks
measure: Anthropometric measurements
timeFrame: 10 weeks
measure: Percentage of water
timeFrame: 10 weeks
measure: Percentage of fat
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Ponferrada
country: Spain
facility: Universidad de León
state: León
Study officials:
References: