- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04166084
Trunk Stabilization Exercises at Lipoedema Patients
The Effect of Trunk Stabilization Exercises on Postural Stability at Lipoedema Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thirty female patients with upper and lower leg lipedemia were included in the study.
Subjects were divided into two groups as experimental (n = 15) and control (n = 15).
The physiotherapy program of the control group will consist of active range of motion exercises and the physiotherapy program in the experimental group will include active range of motion exercises as well as trunk stabilization exercises. After recording demographic data of all subjects, limb volume (environmental measurement), body composition analysis, trunk endurance, pain (Visual Analogue Scale), postural stability (Biodex Balance System®) and functional capacities (6-Minute Walk Test) will be taken.
After the six-week treatment program, all evaluations will be repeated. SPSS (SPSS 21.0) program was used for statistical analysis of the data. Significance level in all analyzes will be accepted as p <0.05.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosed with lower or upper type lipedema
- to be able to understand Turkish
- being older than 18 years
Exclusion Criteria:
- diagnosed with vestibular disorders
- having orthopedic or neurologic co morbidities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Patients in this group will receive active ROM exercises, 10 repeats X 3 times a day, 5 days a week for 6 weeks.
All exercises will be performed at home .
|
Active ROM exercises programme will include hip flexion-extention, hip abduction-adduction, hip internal-external rotation, knee flexion-extention and ankle dorsi-plantar flextion exercises.
|
|
Experimental: Training group
I addition to active ROM exercises, patients in this group will also receive trunk stabilization exercises training for 45 minutes, 2 times a week for 6 weeks.
All exercises sessions will be supervised by a physiotherapist in a clinic per week.
|
Active ROM exercises programme will include hip flexion-extention, hip abduction-adduction, hip internal-external rotation, knee flexion-extention and ankle dorsi-plantar flextion exercises.
Trunk stabilization exercises training will be given under the supervision of a physiotherapist.
This training exercises will include diphragmatic exrecises, posterior pelvic tilt exercises, abdominal streghtening exercises,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Extremity volume
Time Frame: Six weeks
|
tape measurements
|
Six weeks
|
|
Body Composition
Time Frame: Six weeks
|
fat mass; muscle mass
|
Six weeks
|
|
Extremity pain
Time Frame: Six weeks
|
Visual Analog Scale
|
Six weeks
|
|
Endurance
Time Frame: Six weeks
|
Abdominal endurance tests
|
Six weeks
|
|
Balance
Time Frame: Six weeks
|
Change from baseline postural stability test score in BIODE Balance System at 6 weeks.
|
Six weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bvuakos1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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