Impact of Physical Exercise on Lymphedema Related to Breast Cancer: Assessment Using Thermography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Perimeters
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CONTROL GROUP
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
INTERVENTION GROUP
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
Intervention: Aerobic and Strength Exercise (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Percentage of fat(10 weeks)
- Bicipital and Tricipital Skinfolds(10 weeks)
- RS-14 Questionnaire (Resilience Scale for Adults)(10 weeks)
- Trait Meta-Mood Scale (TMMS-24)(10 weeks)
- MOS Social Support Survey (MOS-SSS)(10 weeks)
- Anthropometric measurements(10 weeks)
- Percentage of water(10 weeks)
Investigators
Marta Arias Crespo
Graduate in nursing
Universidad de León