Trunk Stabilization Exercises at Lipoedema Patients

November 15, 2019 updated by: Alis Kostanoğlu, Bezmialem Vakif University

The Effect of Trunk Stabilization Exercises on Postural Stability at Lipoedema Patients

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

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

No

Studies a U.S. FDA-regulated device product

No

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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