Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema

Telerehabilitation Clinical Trial

Official title:

Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06065423
• Other study ID #: 09.2021.131
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'Telerehabilitation'. The purpose of our study is to evaluate the treatment process and adherence of patients undergoing telerehabilitation.

Description:

Our study is a randomized single-blind prospective study. Patients aged 18 to 75 years with stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had undergone breast surgery at least 3 months prior, were included in the study. Group 1: Patients were given a brochure explaining the massage and exercises they should perform. They were periodically contacted by a physiotherapist and clinician to remind them of their tasks. Group 2: Patients underwent telerehabilitation exercises and massages three times a week guided by a physiotherapist and clinician, and on the remaining days, they continued their self-administered tasks. Patients were evaluated three times: before treatment, at weeks 5 and 8 after treatment. During each visit, patients' inter-limb volume difference, Quick DASH and Life Impact Scale scores, pain, tension, stiffness, and heaviness sensations were assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who had undergone breast surgery at least 3 months ago

• Had stage 1-2 lymphedema

• Had upper extremity lymphedema associated with breast cancer

Exclusion Criteria:

• Signs of infection such as lymphangitis, cellulitis, fungal infections

• Those with documented lymph node metastases

• Those with bilateral lymphedema

• Those with other diseases affecting upper extremity functions

• Those with a history of previous surgery related to the upper extremity

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• Lymphedema
• Telerehabilitation

Intervention

Other:
• Manuel Lymphatic Drainage(MLD), Exercises
MLD:It is a unique massage technique that uses specific hand movements to provide a gentle pumping effect on the skin. Massage movements follow the direction of lymph flow and produce rapid results. The aim of this method is to achieve maximum skin tightening effect with minimum pressure. Exercise, on the other hand, increases physical performance, improves body composition, and provides an increase in quality of life by providing acute and chronic reductions in fatigue. Both aerobic exercises and strengthening exercises have been found effective on physical performance. It shows that a mixed program consisting of components such as aerobics, strengthening, coordination and stretching can positively affect flexibility, pain and energy expenditure in breast cancer patients.

Locations

Country	Name	City	State
Turkey	Canan Sanal-Toprak	Istanbul
Turkey	Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume Measurements	Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3	Time Frame: Day 0
Primary	Volume Measurements	Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3	Time Frame: 5 weeks
Primary	Volume Measurements	Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3	Time Frame: 8 weeks
Primary	Symptom Severity	Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)	Time Frame: Day 0
Primary	Symptom Severity	Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)	Time Frame: 5 weeks
Primary	Symptom Severity	Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)	Time Frame: 8 weeks
Primary	Functionality	Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire	Time Frame: Day 0
Primary	Functionality	Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire	Time Frame: 5 weeks
Primary	Functionality	Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire	Time Frame: 8 weeks
Primary	Efficacity	Lymphedema Quality of Life Impact Scale	Time Frame: Day 0
Primary	Efficacity	Lymphedema Quality of Life Impact Scale	Time Frame: 5 weeks
Primary	Efficacity	Lymphedema Quality of Life Impact Scale	Time Frame: 8 weeks
Secondary	Patient satisfaction with the treatment	Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied	Time Frame: 5 weeks
Secondary	Patient satisfaction with the treatment	Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied	Time Frame: 8 weeks
Secondary	patients were asked to compare their hand functionality to before the injury	Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse	Time Frame: 5 weeks
Secondary	patients were asked to compare their hand functionality to before the injury	Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse	Time Frame: 8 weeks