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

NCT ID: NCT04421807

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2021-06-30

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.

Conditions

Lymphedema; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Scapulatoracic stabilization exercises

Intervention Type: OTHER

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)

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Complex decongestive therapy (CDT)

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ataturk Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seyda TOPRAK CELENAY

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seyda TOPRAK CELENAY

Role: PRINCIPAL_INVESTIGATOR

Ankara Yildirim Beyazıt University

Locations

Ankara Yildirim Beyazit University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Seyda TOPRAK CELENAY

Role: CONTACT

sydtoprak@hotmail.com

+90-534-041-3986

Facility Contacts

Seyda Toprak Celenay

Role: primary

sydtoprak@hotmail.com

Other Identifiers

2020/05/29

Identifier Type: -

Identifier Source: org_study_id