Clinical trial NCT06545383: The Effect of Dynamic Neuromuscular Stabilization Exercises in Patients With Lower Extremity Lymphedema
Official title: The Effect of Dynamic Neuromuscular Stabilization Exercises on Balance, Proprioception and Functional Level in Patients With Lower Extremity Lymphedema
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lymphedema, Lower Limb
Keywords: Lower Extremity Lymphedema
Exercise
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2024-08-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing two exercise groups
Primary purpose: TREATMENT

Brief summary: After lower extremity lymphedema, individuals physical activity levels and functionality remain very low. This decrease can cause balance problems over time. Surgical and medical treatments reduce the nerve conduction efficiency of the nervous system and negatively affect proprioception, which is the perception of the joint's position in space during movement. Increasing errors in joint position sense reduce control of movement and restrict active movement, which lead to an assumption that balance could be affected. Joint position sense and balance may be negatively affected, causing injuries, and injuries may cause damage to ligaments and sensory nerve fibers. The main aim of the Dynamic Neuromuscular Stabilization (DNS) approach is to restore physiological movement patterns. By activating the deep stabilizer system with DNS exercises, joint movements could improved, and exercise positions will have positive effects on the quality of sensory perception. In addition, positive effects on balance are expected due to decrease in joint position sense errors. Therefore, the aim of the study is to investigate/understand the effect of DNS exercises on balance, proprioception and functional level in patients with lower extremity lymphedema. This study will provide information for researchers, therapists, and patients by determining the effectiveness of DNS exercises in patients with lower extremity lymphedema.

from Bezmiâlem Vakıf University Faculty of Medicine, Department of Physical Therapy and Rehabilitation, who have been diagnosed with lymphedema due to primary or secondary causes and have progressed to the Complex Decongestive Treatment Phase 2, will constitute the population of the study. The study will be carried out at Istanbul University-Cerrahpaşa Department of Physiotherapy and Rehabilitation.

The study will consist of two groups. Both groups will be included in an exercise program consisting of breathing exercises, active joint range of motion exercises and walking training. Exercises will be given as a home program for 6 weeks, 3 days a week, 45 minutes a day. Additionally, patients in the Control group will be asked to walk for 40 minutes 2 days a week for 6 weeks. In the intervention group, they will additionally be included in a program consisting of individualized DNS exercises for 40 minutes a day, 2 days a week for 6 weeks. All patients will be asked to wear compression garments during exercises.

Detailed description: The study will be carried out with 42 cases referred from Bezmialem Vakif University Faculty of Medicine Hospital Physical Therapy and Rehabilitation Clinic. It will be carried out at Istanbul University-Cerrahpasa Department of Physiotherapy and Rehabilitation. Patients will be randomly divided into Intervention and Control groups. Both groups will be included in an exercise program consisting of breathing exercises that stimulate the lymphatic system in the thoracic region, active joint range of motion exercises and walking training to increase muscle strength and endurance. Exercises will be given as a home program for 6 weeks, 3 days a week, 45 minutes a day. Additionally, patients in the Control Group will be asked to walk for 40 minutes 2 days a week for 6 weeks. In the Intervention Group, they will additionally be included in a program consisting of different postural positions and individualized Dynamic Neuromuscular Stabilization (DNS) exercises added while maintaining the position, 2 days a week, 40 minutes a day for 6 weeks. All patients will be asked to wear compression garments during exercises. Patients' demographic information (age, height, weight, dominant extremity, occupation and education level), duration (years) and stage of lymphedema complaints, and medical history (chemotherapy, radiotherapy and surgical treatment) will be questioned. Participants' lower extremity edema will be evaluated with a tape measure. Their static balance will be evaluated by the one-leg standing test, their dynamic balance by the Y balance test, and their proprioception sense by the joint position sense test. The functional levels of the patients will be evaluated using the 10-meter walk test and the 'Lower Extremity Functional Scale'. Additionally, individuals' fear of falling will be questioned with the 'International Fall Activity Scale'. All evaluations will be made before treatment and after the 6th week of treatment is completed. The sample size was calculated with the G\* Power 3.1 power analysis program. Considering the effect size of edema evaluation, which is one of the outcome measurements, as 0.90, the sample size required for a 95% study power was calculated with a 95% confidence interval. It was determined that the number of cases to be included in each group was at least 19. In order to preserve the 95% study power against the possibility of cases falling out of the study, 21 cases will be included by adding a 10% drop margin to each group. Statistical analysis of the data obtained from the study "Statistical Package for Social Sciences" (SPSS) Version 22.0 (SPSS inc., Chicago, USA) statistical program. Whether the data conforms to normal distribution will be determined by the " Shapiro-Wilk Test". According to the analysis results of this test, parametric tests will be applied in the analysis of data that conforms to normal distribution, and non -parametric tests will be applied in the analysis of data that does not comply with normal distribution. In the statistical analysis of the study, the variables evaluated will be defined with mean (Mean), standard deviation (SD) and percentage (%) values. For quantitative/numerical data comparing the demographic and clinical characteristics of the groups that make up the study, Independent Samples T-test and Chi-square test will be used for qualitative/non-numerical data. Results will be considered significant at the 95% confidence interval and significance level of p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* Being diagnosed with lymphedema due to primary or secondary causes in the lower extremity
* Having progressed to Complex Decongestive Treatment Phase 2
* Volunteering to participate in research

Exclusion Criteria:

* No mental or cognitive problems
* Not receiving any other concurrent conservative or surgical treatment during the study.
* Presence of metastatic cancer
* Having a neurological disorder that may affect balance or an orthopedic disorder that may prevent walking
* Presence of active infection in the affected limb
* Uncontrolled hypertension, presence of serious cardiovascular system disease
* There is a risk of deep vein thrombosis
* Presence of open skin wound
* Having a history of falling in the last 3 months

Primary outcomes:
measure: Change from Baseline in Static Balance on the One-Leg Stance Test
timeFrame: Six week
measure: Change from Baseline in Dynamic Balance on the Y Balance Test
timeFrame: Six week
Secondary outcomes:
measure: Change from Baseline in Proprioception on the Joint Position Sense Test
timeFrame: Six week
measure: Change from Baseline in Functional Level on the 10 Meters Walking Test
timeFrame: Six week
measure: Change from Baseline in Functional Level on the Lower Extremity Functional Scale
timeFrame: Six week
measure: Change from Baseline in Edema on the Environmental Measurement Methods
timeFrame: Six week
measure: Change from Baseline in Fear of Falling on the Falls Efficacy Scale International (FES-I)
timeFrame: 6 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Büyükçekmece
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Büşra Çiftçi, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Rüstem Mustafaoğlu, Assoc Prof D
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Teoman Aydın, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: