Trunk Stabilization Exercises at Lipoedema Patients

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04166084

Collaborator

(none)

Enrollment

Arms

3.4

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lipedema	Other: Active ROM Exercises Other: Trunk Stabilization Exercises Training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 15, 2019

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Feb 28, 2020

Arms and Interventions

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 .	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.
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.	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. Other: 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,

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 .

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.

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.

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.

Other: 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,

Outcome Measures

Primary Outcome Measures

Extremity volume [Six weeks]
tape measurements
Body Composition [Six weeks]
fat mass; muscle mass
Extremity pain [Six weeks]
Visual Analog Scale
Endurance [Six weeks]
Abdominal endurance tests
Balance [Six weeks]
Change from baseline postural stability test score in BIODE Balance System at 6 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alis Kostanoğlu, Assist. Prof., Bezmialem Vakif University

ClinicalTrials.gov Identifier:

NCT04166084

Other Study ID Numbers:

bvuakos1

First Posted:

Nov 18, 2019

Last Update Posted:

Nov 18, 2019

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alis Kostanoğlu, Assist. Prof., Bezmialem Vakif University

lipedema

postural stability

trunk stabilization exercises

Additional relevant MeSH terms:

Lipedema

Study Results

No Results Posted as of Nov 18, 2019