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

NCT ID: NCT06905639

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2025-01-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Aerobic and Strength Exercise

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerobic and Strength Exercise

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 Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leon

UNKNOWN

Sponsor Role: collaborator

Marta Arias Crespo

OTHER

Sponsor Role: lead

Responsible Party

Marta Arias Crespo

Graduate in nursing

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Universidad de León

Ponferrada, León, Spain

Countries

Spain

Other Identifiers

No aplicable

Identifier Type: OTHER

Identifier Source: secondary_id

ETICA-ULE-055-2024

Identifier Type: -

Identifier Source: org_study_id