Effects of Scapulathoracic Stabilization Exercises Plus Complex Decongestive Therapy in Women With Lymphedema
Primary Purpose
Lymphedema, Exercise
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Scapulatoracic stabilization exercises
Complex decongestive therapy (CDT)
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema focused on measuring Lymphedema, decongestive therapy, exercise, posture, balance
Eligibility Criteria
Inclusion Criteria:
- 18 to 65 years of age
- Agree to participate in the study,
- Undergoing unilateral mastectomy due to breast cancer treatment and additionally development of limb lymphedema,
- Lymphedema stage 2 and 3,
- Being a woman,
- Having spent at least 6 months after the operation
- With or without radiotherapy and / or chemotherapy.
Exclusion Criteria:
- Irregular participation to the treatment program,
- Severe heart failure and / or rhythm disturbance,
- Uncontrolled hypertension,
- Presence of metastasis,
- Infection in the affected arm,
- Any problems that may affect balance (rheumatological, vestibular, visual, neurological),
- Muscular and skeletal system problems (limb shortness, ankle sprain ...), which may affect the balance and posture negatively.
- Presence of spinal deformity,
- Those who have had spinal surgery in the last 6 months.
Sites / Locations
- Ankara Yildirim Beyazit UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise+Complex decongestive therapy (CDT) group
Only Complex decongestive therapy (CDT) group
Arm Description
The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study
The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study
Outcomes
Primary Outcome Measures
Thoracic khyphosis
Thoracic Kyphosis will be evaluated with digital inclinometer device (Baseline® Digital İnclinometer).
Posture angle
Posture angle will be evaluated with the PostureScreen Mobile (HuaweiTechnologies Co. Ltd, FIG-LX1, Android) application installed on a smartphone
General posture status
General posture status will be evaluated with the New York Posture Scale, postural changes that can occur in 13 different parts of the body are scored by observing the individual posteriorly and laterally. Each parameter is given 5 if smooth, 3 if moderately impaired, 1 if severely impaired. At the end of the scoring minimum 13, maximum 65 points can be obtained.
Secondary Outcome Measures
Balance
Balance will be evaluated with MINIBESTEST. It includes sub-parameters of Intuitive, Reactive Postural Control, Sensory Orientation, Dynamic Walk. Each parameter has its own scoring and the total score is obtained by adding all of them. In the test consisting of 14 items, each parameter is given a score between 0-2. 0 indicates the lowest function level, 2 indicates the highest function level. A maximum of 28 points is obtained at the end of the scoring.
Quality of life outcomes
It will be evaluated with Lymphedema Quality of Life Questionnaire. The survey consists of 21 questions. The first part of the 20 questions contains the questions of function, appearance, symptom and mood, and the last question evaluates the overall quality of life. The first 20 questions area scoring is not at all (1), a little (2), quite (3), many (4). The total score ranges from "1" to "4" and is obtained by dividing the sum of the question scores answered by the number of questions. A high score indicates that the quality of life is low. The last question that assesses the overall health status is between 0 (bad) and 10 (excellent).
The severity of the lymphoedema
For the evaluation of the severity of the lymphoedema, circumferential measurements in centimeters on bilateral upper extremities. at 5-cm intervals from wrist to axilla will be used
Lymphedema symptoms
Pain, numbness, tingling, fatigue, feeling of heaviness in lymphedema symptoms were evaluated individually with Visual Analogue Scale. This scale is a 10 cm line with no marks along them, anchored with thewords"no pain"on one hand, and"the most severe pain"on theother. Participants will be simply instructed to place a mark alongthe line at a level representing the intensity of their pain,Pain, numbness, tingling, fatigue, feeling of heaviness.
Range of motion of shoulder
Range of motion will be evaluated with Baseline Universal Goniometer
Scapulatoracic muscle strength
It was evaluated with digital hand-held dynamometer (Commander Echo Manual Muscle Testing Device by JTECH) for upper, middle and lower trapezius muscle.
Scapular dyskinesia
It will be evaluated with Lateral Scapular Slide Test, Wall Push Up Test and Scapular Isometrik Pinch Test.
Upper extremity functions
It will be evaluated using Arm Shoulder and Hand Problems Survey.This questionnaire consists of 30 questions. The first 20 questions question physical adequacy, the last 10 questions pain and the functional and environmental constraint associated with it. The total score takes between 0 and 100 points. Higher score means more disability.
Full Information
NCT ID
NCT04421807
First Posted
May 29, 2020
Last Updated
June 4, 2020
Sponsor
Ataturk Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04421807
Brief Title
Effects of Scapulathoracic Stabilization Exercises Plus Complex Decongestive Therapy in Women With Lymphedema
Official Title
Investigation of the Effects of Scapulathoracic Stabilization Exercises Additionally Applied to Complex Decongestive Therapy After Mastectomy on Posture, Balance and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the study is to investigate the effects of scapulathoracic stabilization exercises additionally applied to complex decongestive therapy after mastectomy on posture, balance and quality of life.
Detailed Description
Lymphedema is a chronic and progressive condition that occurs with the accumulation of protein-rich fluid in interstitial tissue spaces as a result of abnormal development or damage to the lymphatic system. Lymphedema is divided into 2 as primary and secondary. Secondary lymphedema is the most common form seen in upper extremity, usually after breast cancer treatment approaches. In lymphedema, not only upper limb affected, but also posture, balance, shoulder girdle, scapula and quality of life can be adversely affected. Complex decongestive therapy has been accepted as the gold standard treatment in lymphedema to reduce edema, however, there were insufficient studies investigating the effects on the posture and the balance in patients with lymphedema. Scapulatoracic stabilization exercises aim to increase muscle stability ability, kinesthetic awareness, ovarall stability and balance. However, when the literature is reviewed, no study is found investigating the effect of scapulatoracic stabilization exercises in individuals who developed lymphedema after mastectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Exercise
Keywords
Lymphedema, decongestive therapy, exercise, posture, balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise+Complex decongestive therapy (CDT) group
Arm Type
Experimental
Arm Description
The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study
Arm Title
Only Complex decongestive therapy (CDT) group
Arm Type
Active Comparator
Arm Description
The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study
Intervention Type
Other
Intervention Name(s)
Scapulatoracic stabilization exercises
Intervention Description
Scapulatoracic stabilization exercises consisted of 3 phases; the warming phase which consists of mobility and stretching; exercise phase consisting of static, dynamic and functional phase; the cooling phase consisting of mobility and stretching. Scapulatoracic stabilization exercises additionally applied to CDT were performed 3 days a week for 8 weeks. These exercises were specially planned for the patients and applied gradually
Intervention Type
Other
Intervention Name(s)
Complex decongestive therapy (CDT)
Intervention Description
In the treatment phase of CDT, manual lymph drainage, skin care, compression bandage, draining exercise were applied 5 days a week for 3 weeks. Compression socks, self-drainage, skin care and unloading exercises were applied for 5 weeks in the protection phase of CDT. Thus, patients were followed up with the CDT program for 8 weeks.
Primary Outcome Measure Information:
Title
Thoracic khyphosis
Description
Thoracic Kyphosis will be evaluated with digital inclinometer device (Baseline® Digital İnclinometer).
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Title
Posture angle
Description
Posture angle will be evaluated with the PostureScreen Mobile (HuaweiTechnologies Co. Ltd, FIG-LX1, Android) application installed on a smartphone
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Title
General posture status
Description
General posture status will be evaluated with the New York Posture Scale, postural changes that can occur in 13 different parts of the body are scored by observing the individual posteriorly and laterally. Each parameter is given 5 if smooth, 3 if moderately impaired, 1 if severely impaired. At the end of the scoring minimum 13, maximum 65 points can be obtained.
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Secondary Outcome Measure Information:
Title
Balance
Description
Balance will be evaluated with MINIBESTEST. It includes sub-parameters of Intuitive, Reactive Postural Control, Sensory Orientation, Dynamic Walk. Each parameter has its own scoring and the total score is obtained by adding all of them. In the test consisting of 14 items, each parameter is given a score between 0-2. 0 indicates the lowest function level, 2 indicates the highest function level. A maximum of 28 points is obtained at the end of the scoring.
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Title
Quality of life outcomes
Description
It will be evaluated with Lymphedema Quality of Life Questionnaire. The survey consists of 21 questions. The first part of the 20 questions contains the questions of function, appearance, symptom and mood, and the last question evaluates the overall quality of life. The first 20 questions area scoring is not at all (1), a little (2), quite (3), many (4). The total score ranges from "1" to "4" and is obtained by dividing the sum of the question scores answered by the number of questions. A high score indicates that the quality of life is low. The last question that assesses the overall health status is between 0 (bad) and 10 (excellent).
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Title
The severity of the lymphoedema
Description
For the evaluation of the severity of the lymphoedema, circumferential measurements in centimeters on bilateral upper extremities. at 5-cm intervals from wrist to axilla will be used
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Title
Lymphedema symptoms
Description
Pain, numbness, tingling, fatigue, feeling of heaviness in lymphedema symptoms were evaluated individually with Visual Analogue Scale. This scale is a 10 cm line with no marks along them, anchored with thewords"no pain"on one hand, and"the most severe pain"on theother. Participants will be simply instructed to place a mark alongthe line at a level representing the intensity of their pain,Pain, numbness, tingling, fatigue, feeling of heaviness.
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Title
Range of motion of shoulder
Description
Range of motion will be evaluated with Baseline Universal Goniometer
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Title
Scapulatoracic muscle strength
Description
It was evaluated with digital hand-held dynamometer (Commander Echo Manual Muscle Testing Device by JTECH) for upper, middle and lower trapezius muscle.
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Title
Scapular dyskinesia
Description
It will be evaluated with Lateral Scapular Slide Test, Wall Push Up Test and Scapular Isometrik Pinch Test.
Time Frame
change from baseline , at 4 weeks and at 8 weeks
Title
Upper extremity functions
Description
It will be evaluated using Arm Shoulder and Hand Problems Survey.This questionnaire consists of 30 questions. The first 20 questions question physical adequacy, the last 10 questions pain and the functional and environmental constraint associated with it. The total score takes between 0 and 100 points. Higher score means more disability.
Time Frame
change from baseline , at 4 weeks and at 8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with lymphedema after mastectomy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 65 years of age
Agree to participate in the study,
Undergoing unilateral mastectomy due to breast cancer treatment and additionally development of limb lymphedema,
Lymphedema stage 2 and 3,
Being a woman,
Having spent at least 6 months after the operation
With or without radiotherapy and / or chemotherapy.
Exclusion Criteria:
Irregular participation to the treatment program,
Severe heart failure and / or rhythm disturbance,
Uncontrolled hypertension,
Presence of metastasis,
Infection in the affected arm,
Any problems that may affect balance (rheumatological, vestibular, visual, neurological),
Muscular and skeletal system problems (limb shortness, ankle sprain ...), which may affect the balance and posture negatively.
Presence of spinal deformity,
Those who have had spinal surgery in the last 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda TOPRAK CELENAY
Phone
+90-534-041-3986
Email
sydtoprak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda TOPRAK CELENAY
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yildirim Beyazit University
City
Ankara
ZIP/Postal Code
06760
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Celenay
Email
sydtoprak@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Scapulathoracic Stabilization Exercises Plus Complex Decongestive Therapy in Women With Lymphedema
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