Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema

Completed

• Conditions: Lymphedema Arm; Lymphedema; Surgical
• Interventions: Other: Complete Decongestion Therapy

• Registration Number: NCT03945838
• Lead Sponsor: Ege University

Brief Summary

This study aims to find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Patients were taken their demographic and clinical history and were evaluated with measurements of extremity volumes and hand grip strengths using a hand dynamometer before and after the complete decongestive therapy. Data were then assessed using relevant statistical methods.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-04
• Primary Completion: 2018-04-24
• Study Completion: 2018-04-24
• Status Verified: 2019-05
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-09
• Last Update Submitted: 2019-05-09
• Study First Posted: 2019-05-10
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

• Having had mastectomy or breast conserving surgery
• Having a certain diagnosis of lymphedema with a difference in arm circumferences more than 1 cm

Exclusion Criteria

• The subjects with active infection or cancer with metastases, the ones who didn't accept the complete decongestive therapy, patients with vascular disease, rheumatic disease, upper limb deformity, any upper limb surgery history, bilateral lymphedema or a history of transplantation were excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer related lymphedema	Complete Decongestion Therapy	All patients were included in the complete decongestive therapy programme. This therapy includes patient education, skin care, exercises, manual lymphatic drainage (self), and compression bandage therapy.

Primary Outcome Measures

Name	Time	Method
Hand grip strength	3 weeks	Hand grip strength: Hand grip strength was measured using JAMAR® hand dynamometer. It has been used to assess hand grip strength in many studies over half a century. Patients were asked to sit down with shoulder adducted, elbow flexed (90°) and forearm in the neutral position. Mean of the 3 measurements taken with 1 minute apart from each other was recorded. Patients' measurements were taken for both affected and unaffected arm, and recorded as kgf.
Extremity volume	3 weeks	Volume measurements were taken using ulnar styloid process as a index point, and circumferential measurements were taken with 5 cm spaces from distal to the proximal. Using a computer programme (Limb Volumes Professional version 5.0), the total volume of the arm was calculated and recorded before and after the treatment for both arms.; All patients' measurements were taken by the same researcher.

Trial Locations

Locations (1)

Ege university school of medicine; 🇹🇷 Izmir, Turkey