LipedemaNCT04166084
Trunk Stabilization Exercises at Lipoedema Patients
A study testing Active ROM Exercises and Trunk Stabilization Exercises Training in people with Lipedema, run by Bezmialem Vakif University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Active ROM Exercises and Trunk Stabilization Exercises Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with lower or upper type lipedema
- to be able to understand Turkish
- being older than 18 years
Who cannot join
- diagnosed with vestibular disorders
- having orthopedic or neurologic co morbidities
About this study
Official title: 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.
Read the 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.
- Conditions
- Lipedema
- Being tested
- Active ROM Exercises, Trunk Stabilization Exercises Training
- Keywords
- lipedema, postural stability, trunk stabilization exercises
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ROM ExercisesOther
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 TrainingOther
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,
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Other: Active ROM Exercises; Other: Trunk Stabilization Exercises Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extremity volume
tape measurements
Measured: Six weeks
Body Composition
fat mass; muscle mass
Measured: Six weeks
Extremity pain
Visual Analog Scale
Measured: Six weeks
Endurance
Abdominal endurance tests
Measured: Six weeks
Balance
Change from baseline postural stability test score in BIODE Balance System at 6 weeks.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start15 Nov 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alis Kostanoğlu, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166084
- Sponsor's protocol ID
- bvuakos1
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trunk Stabilization Exercises on Postural Stability at Lipoedema Patients
- ClinicalTrials.gov ID
- NCT04166084
- Acronym / sponsor ID
- bvuakos1
- Conditions
- Lipedema
- Keywords
- lipedema, postural stability, trunk stabilization exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Active ROM ExercisesPatients 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 . |
| Training group | Experimental | Other: Active ROM Exercises, Other: Trunk Stabilization Exercises TrainingI 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with lower or upper type lipedema
- to be able to understand Turkish
- being older than 18 years
Key exclusion criteria (2 listed)
- diagnosed with vestibular disorders
- having orthopedic or neurologic co morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active ROM ExercisesActive 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 | Control Group, Training group |
| Trunk Stabilization Exercises TrainingTrunk 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, | Other | Training group |
Primary outcome
Extremity volume
Time frame: Six weeks
tape measurements
Body Composition
Time frame: Six weeks
fat mass; muscle mass
Extremity pain
Time frame: Six weeks
Visual Analog Scale
Endurance
Time frame: Six weeks
Abdominal endurance tests
Balance
Time frame: Six weeks
Change from baseline postural stability test score in BIODE Balance System at 6 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Active ROM Exercises and Trunk Stabilization Exercises Training in people with Lipedema, run by Bezmialem Vakif University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extremity volume (time frame: Six weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.