Clinical trial NCT04421807: Effects of Scapulathoracic Stabilization Exercises Plus Complex Decongestive Therapy in Women With Lymphedema
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema
Exercise
Keywords: Lymphedema
decongestive therapy
exercise
posture
balance
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Thoracic khyphosis
timeFrame: change from baseline , at 4 weeks and at 8 weeks
measure: Posture angle
timeFrame: change from baseline , at 4 weeks and at 8 weeks
measure: General posture status
timeFrame: change from baseline , at 4 weeks and at 8 weeks
Secondary outcomes:
measure: Balance
timeFrame: change from baseline , at 4 weeks and at 8 weeks
measure: Quality of life outcomes
timeFrame: change from baseline , at 4 weeks and at 8 weeks
measure: The severity of the lymphoedema
timeFrame: change from baseline , at 4 weeks and at 8 weeks
measure: Lymphedema symptoms
timeFrame: change from baseline , at 4 weeks and at 8 weeks
measure: Range of motion of shoulder
timeFrame: change from baseline , at 4 weeks and at 8 weeks
measure: Scapulatoracic muscle strength
timeFrame: change from baseline , at 4 weeks and at 8 weeks
measure: Scapular dyskinesia
timeFrame: change from baseline , at 4 weeks and at 8 weeks
measure: Upper extremity functions
timeFrame: change from baseline , at 4 weeks and at 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda TOPRAK CELENAY
role: PRINCIPAL_INVESTIGATOR
References: