search
Back to results

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
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipedema focused on measuring lipedema, postural stability, trunk stabilization exercises

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

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

    First Posted
    November 13, 2019
    Last Updated
    November 15, 2019
    Sponsor
    Bezmialem Vakif University
    search

    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

    Learn more about this trial

    Trunk Stabilization Exercises at Lipoedema Patients

    We'll reach out to this number within 24 hrs