Impact of Physical Exercise on Lymphedema Related to Breast Cancer: Assessment Using Thermography

NCT06905639 | Completed

• 2 other identifiers: ETICA-ULE-055-2024No aplicable
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Lymphedema; Thermography; Exercise

Keywords

Breast Neoplasms; Lymphedema; Exercise; Thermography

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  10 weeks

Secondary Outcomes (7)

• 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

Study Arms (2)

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

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

Interventions

Aerobic and Strength Exercise BEHAVIORAL

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

INTERVENTION GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marta Arias Crespo: lead
• University of Leon: collaborator

Study Sites (1)

Universidad de León

Ponferrada, León, 24400, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate in nursing

Model Details: 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

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 1, 2025
• Study Start: November 4, 2024
• Primary Completion: December 13, 2024
• Study Completion: January 13, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)