Effects of Scapulathoracic Stabilization Exercises Plus Complex Decongestive Therapy in Women With Lymphedema

Investigation of the Effects of Scapulathoracic Stabilization Exercises Additionally Applied to Complex Decongestive Therapy After Mastectomy on Posture, Balance and Quality of Life

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.

Study Overview

• Status: Unknown
• Conditions: Lymphedema; Exercise
• Intervention / Treatment: Other: Scapulatoracic stabilization exercises; Other: Complex decongestive therapy (CDT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06760
    • Recruiting
    • Ankara Yildirim Beyazit University
    • Contact: Seyda Toprak Celenay; Email: sydtoprak@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise+Complex decongestive therapy (CDT) group; The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study	Other: Scapulatoracic stabilization exercises; 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; Other: Complex decongestive therapy (CDT); 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.
ACTIVE_COMPARATOR: Only Complex decongestive therapy (CDT) group; The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study	Other: Complex decongestive therapy (CDT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thoracic khyphosis	Thoracic Kyphosis will be evaluated with digital inclinometer device (Baseline® Digital İnclinometer).	change from baseline , at 4 weeks and at 8 weeks
Posture angle	Posture angle will be evaluated with the PostureScreen Mobile (HuaweiTechnologies Co. Ltd, FIG-LX1, Android) application installed on a smartphone	change from baseline , at 4 weeks and at 8 weeks
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.	change from baseline , at 4 weeks and at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline , at 4 weeks and at 8 weeks
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).	change from baseline , at 4 weeks and at 8 weeks
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	change from baseline , at 4 weeks and at 8 weeks
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.	change from baseline , at 4 weeks and at 8 weeks
Range of motion of shoulder	Range of motion will be evaluated with Baseline Universal Goniometer	change from baseline , at 4 weeks and at 8 weeks
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.	change from baseline , at 4 weeks and at 8 weeks
Scapular dyskinesia	It will be evaluated with Lateral Scapular Slide Test, Wall Push Up Test and Scapular Isometrik Pinch Test.	change from baseline , at 4 weeks and at 8 weeks
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.	change from baseline , at 4 weeks and at 8 weeks

Collaborators and Investigators

• Sponsor: Ataturk Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2020
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Lymphedema; exercise; balance; posture; decongestive therapy
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 2020/05/29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No