The Effect of Dynamic Neuromuscular Stabilization Exercises in Patients With Lower Extremity Lymphedema

NCT ID: NCT06545383

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-02-01

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.

Conditions

Lymphedema, Lower Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dynamic Neuromuscular Stabilization Exercises

Participants will be taught face-to-face the same home exercise program that was taught to the Exercise Group. In addition, Dynamic Neuromuscular Stabilization (DNS) exercises will be performed. Participants will be informed about DNS exercises and postures. Progress will be made in the exercises step by step. The exercises performed during the positions will be increased by performing 3 sets of 10 repetitions in the first 3 weeks and 3 sets of 15 repetitions in the last 3 weeks.

Group Type: EXPERIMENTAL

Dynamic Neuromuscular Stabilization Exercises

Intervention Type: OTHER

Exercises will last 45 minutes and will be 3 days a week for 6 weeks. Additionally DNS exercises will be performed in 40-minute sessions, 2 days a week for 6 weeks.

Exercise

Participants will be taught the home exercise program face to face. Exercises will start with diaphragmatic breathing. Breathing exercises will be done in 2 sets of 10 repetitions. Lower extremity joint range of motion exercises; It will consist of hip flexion in the supine position, hip abduction in the side lying position, hip extension and knee flexion in the prone position, knee extension and ankle dorsi-plantar flexion in the sitting position. Exercises will be increased to 3 sets of 10 repetitions for the first 3 weeks, and 3 sets of 15 repetitions after the 3rd week. After the exercises, they will be asked to walk for 20 minutes at moderate intensity on a flat surface. Additionally, the control group will be asked to walk at moderate intensity.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

Exercises will last 45 minutes and will be 3 days a week for 6 weeks. Additionally, the control group will be asked to walk at moderate intensity for 40 minutes, 2 days a week, for 6 weeks.

Interventions

Dynamic Neuromuscular Stabilization Exercises

Exercises will last 45 minutes and will be 3 days a week for 6 weeks. Additionally DNS exercises will be performed in 40-minute sessions, 2 days a week for 6 weeks.

Intervention Type: OTHER

Exercise

Exercises will last 45 minutes and will be 3 days a week for 6 weeks. Additionally, the control group will be asked to walk at moderate intensity for 40 minutes, 2 days a week, for 6 weeks.

Intervention Type: OTHER

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

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

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Büşra Çiftçi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Büşra Çiftçi, BSc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Rüstem Mustafaoğlu, Assoc Prof D

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Teoman Aydın, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Istanbul University-Cerrahpasa

Istanbul, Büyükçekmece, Turkey (Türkiye)

Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Büşra Çiftçi

Role: CONTACT

busraciftci@ogr.iuc.edu.tr

+90 543 628 61 76

Rüstem Mustafaoğlu

Role: CONTACT

rustem.mustafaoglu@iuc.edu.tr

+90 (212) 404 03 00 ext. 53101

Facility Contacts

Büşra Çiftçi, B.Sc

Role: primary

busraciftci@ogr.iuc.edu.tr

+90 543 628 61 76

Büşra Çiftçi, B.Sc.

Role: primary

busraciftci@ogr.iuc.edu.tr

+90 543 628 61 76

Other Identifiers

IUC-FTR-BC-01

Identifier Type: -

Identifier Source: org_study_id