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

NCT04421807 | Unknown

• 1 other identifier: 2020/05/29
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Exercise

Keywords

Lymphedema; decongestive therapy; exercise; posture; balance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Balance

  change from baseline , at 4 weeks and at 8 weeks

• Quality of life outcomes

  change from baseline , at 4 weeks and at 8 weeks

• The severity of the lymphoedema

  change from baseline , at 4 weeks and at 8 weeks

• Lymphedema symptoms

  change from baseline , at 4 weeks and at 8 weeks

• Range of motion of shoulder

  change from baseline , at 4 weeks and at 8 weeks

Study Arms (2)

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

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

Other: Complex decongestive therapy (CDT)

Interventions

Scapulatoracic stabilization exercises 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

Exercise+Complex decongestive therapy (CDT) group

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.

Exercise+Complex decongestive therapy (CDT) group; Only Complex decongestive therapy (CDT) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: women with lymphedema after mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, 06760, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lymphedema; Motor Activity

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavior

Study Officials

• Seyda TOPRAK CELENAY

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda TOPRAK CELENAY

CONTACT

+90-534-041-3986; sydtoprak@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 9, 2020
• Study Start: May 20, 2020
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)