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Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema
| Condition or disease | Intervention/treatment |
|---|---|
| Lymphedema Arm Lymphedema; Surgical | Other: Complete Decongestion Therapy |
| Study Type : | Observational |
| Actual Enrollment : | 74 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema |
| Actual Study Start Date : | April 4, 2017 |
| Actual Primary Completion Date : | April 24, 2018 |
| Actual Study Completion Date : | April 24, 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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.
|
Other: Complete Decongestion Therapy
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. |
- Hand grip strength [ Time Frame: 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 [ Time Frame: 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.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients between 18-70 years old with a history of mastectomy or breast conserving surgery and lymphedema
- Having a certain diagnosis of lymphedema
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
| Turkey | |
| Ege university school of medicine | |
| Izmir, Turkey, 35100 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 8, 2019 | ||||
| First Posted Date | May 10, 2019 | ||||
| Last Update Posted Date | May 10, 2019 | ||||
| Actual Study Start Date | April 4, 2017 | ||||
| Actual Primary Completion Date | April 24, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema | ||||
| Official Title | Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema | ||||
| 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 Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population |
Patients between 18-70 years old with a history of mastectomy or breast conserving surgery and lymphedema
|
||||
| Condition |
|
||||
| Intervention | Other: Complete Decongestion Therapy
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. |
||||
| Study Groups/Cohorts | 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.
Intervention: Other: Complete Decongestion Therapy
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
74 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | April 24, 2018 | ||||
| Actual Primary Completion Date | April 24, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03945838 | ||||
| Other Study ID Numbers | LymphHG | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Göksel Tanıgör M.D., Ege University | ||||
| Study Sponsor | Ege University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Ege University | ||||
| Verification Date | May 2019 | ||||
