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

June 4, 2020 updated by: Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06760
        • Recruiting
        • Ankara Yildirim Beyazit University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thoracic khyphosis
Time Frame: change from baseline , at 4 weeks and at 8 weeks
Thoracic Kyphosis will be evaluated with digital inclinometer device (Baseline® Digital İnclinometer).
change from baseline , at 4 weeks and at 8 weeks
Posture angle
Time Frame: change from baseline , at 4 weeks and at 8 weeks
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
Time Frame: change from baseline , at 4 weeks and at 8 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: change from baseline , at 4 weeks and at 8 weeks
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
Time Frame: change from baseline , at 4 weeks and at 8 weeks
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
Time Frame: change from baseline , at 4 weeks and at 8 weeks
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
Time Frame: change from baseline , at 4 weeks and at 8 weeks
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
Time Frame: change from baseline , at 4 weeks and at 8 weeks
Range of motion will be evaluated with Baseline Universal Goniometer
change from baseline , at 4 weeks and at 8 weeks
Scapulatoracic muscle strength
Time Frame: change from baseline , at 4 weeks and at 8 weeks
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
Time Frame: change from baseline , at 4 weeks and at 8 weeks
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
Time Frame: change from baseline , at 4 weeks and at 8 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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