NCT04166084

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

November 13, 2019

Last Update Submit

November 15, 2019

Conditions

Keywords

lipedemapostural stabilitytrunk stabilization exercises

Outcome Measures

Primary Outcomes (5)

  • Extremity volume

    tape measurements

    Six weeks

  • Body Composition

    fat mass; muscle mass

    Six weeks

  • Extremity pain

    Visual Analog Scale

    Six weeks

  • Endurance

    Abdominal endurance tests

    Six weeks

  • Balance

    Change from baseline postural stability test score in BIODE Balance System at 6 weeks.

    Six weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Training group

EXPERIMENTAL

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 ExercisesOther: Trunk Stabilization Exercises Training

Interventions

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.

Control GroupTraining group

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,

Training group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with lower or upper type lipedema
  • to be able to understand Turkish
  • being older than 18 years

You may not qualify if:

  • diagnosed with vestibular disorders
  • having orthopedic or neurologic co morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 18, 2019

Study Start

November 15, 2019

Primary Completion

February 1, 2020

Study Completion

February 28, 2020

Last Updated

November 18, 2019

Record last verified: 2019-11