Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Izmir, Turkey, 35100
- Ege University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients between 18-70 years old with a history of mastectomy or breast conserving surgery and lymphedema
- Having a certain diagnosis of lymphedema
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Breast cancer related lymphedema
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.
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It is given in two phases. First phase includes intensive therapy which aims to reduce the volume of the extremity. Second phase aims to preserve these reductions of volume. All patients were prescribed lymphedema specific exercises and were advised to walk (for 30 minutes everyday) daywhile taking complete decongestive therapy. They were specifically informed that exercise does not aggravate the severity of their lymphedema. Short stretch bandages were applied to the patients with self manual lymphatic drainage. Intensive phase was given 5 days a week, and short stretch bandages applied for 23 hours a day with 1 hour interval. To increase the local pressure on the areas required, foams were added. Patients were screened with arm circumferential measurements once a week. After gaining a plateau in the volumes, patients were prescribed compression garments. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hand grip strength
Time Frame: 3 weeks
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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.
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3 weeks
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Extremity volume
Time Frame: 3 weeks
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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. |
3 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LymphHG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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