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Clinical Trials/NCT06065423
NCT06065423
Completed
Not Applicable

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

Marmara University2 sites in 1 country40 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Related Lymphedema
Sponsor
Marmara University
Enrollment
40
Locations
2
Primary Endpoint
Symptom Severity
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
June 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Symptom Severity

Time Frame: Time Frame: 8 weeks

Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)

Functionality

Time Frame: Time Frame: 8 weeks

Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire

Efficacity

Time Frame: Time Frame: 8 weeks

Lymphedema Quality of Life Impact Scale

Volume Measurements

Time Frame: Time Frame: 8 weeks

Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3

Secondary Outcomes

  • Patient satisfaction with the treatment(Time Frame: 8 weeks)
  • patients were asked to compare their hand functionality to before the injury(Time Frame: 8 weeks)

Study Sites (2)

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