Trunk Stabilization Exercises at Lipoedema Patients
Primary Purpose
Lipedema
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active ROM Exercises
Trunk Stabilization Exercises Training
Sponsored by
About this trial
This is an interventional treatment trial for Lipedema focused on measuring lipedema, postural stability, trunk stabilization exercises
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Training group
Arm Description
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 .
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.
Outcomes
Primary Outcome Measures
Extremity volume
tape measurements
Body Composition
fat mass; muscle mass
Extremity pain
Visual Analog Scale
Endurance
Abdominal endurance tests
Balance
Change from baseline postural stability test score in BIODE Balance System at 6 weeks.
Secondary Outcome Measures
Full Information
NCT ID
NCT04166084
First Posted
November 13, 2019
Last Updated
November 15, 2019
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04166084
Brief Title
Trunk Stabilization Exercises at Lipoedema Patients
Official Title
The Effect of Trunk Stabilization Exercises on Postural Stability at Lipoedema Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2019 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipedema
Keywords
lipedema, postural stability, trunk stabilization exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Training group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active ROM Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Trunk Stabilization Exercises Training
Intervention Description
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,
Primary Outcome Measure Information:
Title
Extremity volume
Description
tape measurements
Time Frame
Six weeks
Title
Body Composition
Description
fat mass; muscle mass
Time Frame
Six weeks
Title
Extremity pain
Description
Visual Analog Scale
Time Frame
Six weeks
Title
Endurance
Description
Abdominal endurance tests
Time Frame
Six weeks
Title
Balance
Description
Change from baseline postural stability test score in BIODE Balance System at 6 weeks.
Time Frame
Six weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
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Trunk Stabilization Exercises at Lipoedema Patients
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