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

NCT06545383 | Not Yet Recruiting

• 1 other identifier: IUC-FTR-BC-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Lymphedema, Lower Limb

Keywords

Lower Extremity Lymphedema; Exercise

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Static Balance on the One-Leg Stance Test

  With this test, static balance is evaluated. It correlates well with other balance tests. It is time efficient and does not require the use of special equipment. The test is performed without shoes on a smooth and hard surface. It is measured how long the individual can stand on one leg without assistance, with the arms close to the body. The time is recorded with chronometer. The duration starts when the patient lifts his foot off the ground and ends when his foot touches the ground. The test ends when the foot is moved or the time reaches a maximum of 60 seconds. The average of 3 repetitions is taken. The time is recorded in seconds. Standing on one leg for longer periods of time indicates better balance. The test will be applied with eyes open and closed.

  Six week

• Change from Baseline in Dynamic Balance on the Y Balance Test

  The Y balance test evaluates the dynamic balance of the lower extremity. Three lines in the shape of a "Y" are drawn in the test area, with a 135-degree angle between the back strips and the front strip and a 45-degree angle between the back strips. The patient is asked to place his foot on the side to be tested at the intersection of the lines. The patient gently touches the anterior, posteriolateral, posteromedial directions with the other foot and brings it back to the fixed leg. During this time, care is taken not to lift the heel of the other foot. If the balance is disrupted, the test is canceled and repeated. The point where the foot touches is marked and the distance to the intersection point is recorded in centimeters. The test is repeated 3 times and the average is recorded.

  Six week

Secondary Outcomes (5)

• Change from Baseline in Proprioception on the Joint Position Sense Test

  Six week

• Change from Baseline in Functional Level on the 10 Meters Walking Test

  Six week

• Change from Baseline in Functional Level on the Lower Extremity Functional Scale

  Six week

• Change from Baseline in Edema on the Environmental Measurement Methods

  Six week

• Change from Baseline in Fear of Falling on the Falls Efficacy Scale International (FES-I)

  6 week

Study Arms (2)

Dynamic Neuromuscular Stabilization Exercises

EXPERIMENTAL

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.

Other: Dynamic Neuromuscular Stabilization Exercises

Exercise

ACTIVE COMPARATOR

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.

Other: Exercise

Interventions

Dynamic Neuromuscular Stabilization Exercises 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.

Dynamic Neuromuscular Stabilization Exercises

Exercise 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.

Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Bezmialem Vakif University: collaborator

Study Sites (2)

Istanbul University-Cerrahpasa

Istanbul, Büyükçekmece, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphedema; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Büşra Çiftçi, BSc

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Rüstem Mustafaoğlu, Assoc Prof D

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Teoman Aydın, Prof Dr

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Büşra Çiftçi

CONTACT

+90 543 628 61 76; busraciftci@ogr.iuc.edu.tr

Rüstem Mustafaoğlu

CONTACT

+90 (212) 404 03 00; rustem.mustafaoglu@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participant will not know which exercise group she/he is in
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Comparing two exercise groups

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)