LymphedemaNCT04421807
Effects of Scapulathoracic Stabilization Exercises Plus Complex Decongestive Therapy in Women With Lymphedema
A study testing Scapulatoracic stabilization exercises and Complex decongestive therapy (CDT) in people with Lymphedema and Exercise, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lymphedema, Exercise
- What is being tested?
- Scapulatoracic stabilization exercises and Complex decongestive therapy (CDT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yildirim Beyazit University
Ankara, 06760
Seyda Toprak Celenay, sydtoprak@hotmail.com
About this study
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
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.
Read the 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.
- Conditions
- Lymphedema, Exercise
- Being tested
- Scapulatoracic stabilization exercises, Complex decongestive therapy (CDT)
- Keywords
- Lymphedema, decongestive therapy, exercise, posture, balance
- Medical subject headings
- Lymphedema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapulatoracic stabilization exercisesOther
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
Complex decongestive therapy (CDT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise+Complex decongestive therapy (CDT) group | Experimental | The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study Receives: Other: Scapulatoracic stabilization exercises; Other: Complex decongestive therapy (CDT) |
| Only Complex decongestive therapy (CDT) group | Active comparator | The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study Receives: Other: Complex decongestive therapy (CDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic khyphosis
Thoracic Kyphosis will be evaluated with digital inclinometer device (Baseline® Digital İnclinometer).
Measured: 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
Measured: 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.
Measured: change from baseline , at 4 weeks and at 8 weeks
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline , at 4 weeks and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start20 May 2020
- Primary completionJan 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda TOPRAK CELENAY, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421807
- Sponsor's protocol ID
- 2020/05/29
- Status last verified
- Jun 2020
- First submitted
- 29 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04421807
- Acronym / sponsor ID
- 2020/05/29
- Conditions
- Lymphedema, Exercise
- Keywords
- Lymphedema, decongestive therapy, exercise, posture, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise+Complex decongestive therapy (CDT) group | Experimental | Other: Scapulatoracic stabilization exercises, Other: Complex decongestive therapy (CDT)The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study |
| Only Complex decongestive therapy (CDT) group | Active comparator | Other: Complex decongestive therapy (CDT)The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (9 listed)
- Irregular participation to the treatment program,
- Severe heart failure and / or rhythm disturbance,
- Uncontrolled hypertension,
- Presence of metastasis,
- Infection in the affected arm,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scapulatoracic stabilization exercisesScapulatoracic 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 | Exercise+Complex decongestive therapy (CDT) group |
| 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. | Other | Exercise+Complex decongestive therapy (CDT) group, Only Complex decongestive therapy (CDT) group |
Primary outcome
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).
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
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.
8 secondary outcomes
Balance
Time frame: 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
The severity of the lymphoedema
Time frame: change from baseline , at 4 weeks and at 8 weeks
Lymphedema symptoms
Time frame: 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
Scapulatoracic muscle strength
Time frame: change from baseline , at 4 weeks and at 8 weeks
Scapular dyskinesia
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda TOPRAK CELENAY principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapulatoracic stabilization exercises and Complex decongestive therapy (CDT) in people with Lymphedema and Exercise, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda TOPRAK CELENAY (+90-534-041-3986, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic khyphosis (time frame: change from baseline , at 4 weeks and at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.