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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04166084
Other study ID # bvuakos1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2019
Est. completion date February 28, 2020

Study information

Verified date November 2019
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lipedema is a chronic, progressive adipose tissue disorder that is mostly seen as a symmetrical growth of the hips and legs, affecting women. The aim of this study is to investigate the effect of trunk stabilization exercises in addition to active range of motion exercises on body composition, pain, edema, trunk endurance, functional capacity and postural stability.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date February 28, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Active ROM Exercises
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
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,

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Outcome

Type Measure Description Time frame Safety issue
Primary Extremity volume tape measurements Six weeks
Primary Body Composition fat mass; muscle mass Six weeks
Primary Extremity pain Visual Analog Scale Six weeks
Primary Endurance Abdominal endurance tests Six weeks
Primary Balance Change from baseline postural stability test score in BIODE Balance System at 6 weeks. Six weeks
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