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AzTrials

LordosisNCT02903459

Analyze the Relationship Between the Density of Fat Tissue and Cellulite With the Lumbar Lordosis Degree

An observational study of Lordosis, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is analyze the relationship between the density of visceral and subcutaneous fat and cellulite with the lumbar lordosis degree. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Lordosis
How many people
20 participants
Where
1 sitePortugal
Study dates
Jun 2016to Jul 2017
Phase
Observational
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: All the comunity of the School of Allied Health Technologies

Inclusion Criteria: All the community of the School of Allied Health Technologies; aged between 18-60

Exclusion Criteria: Pathologies (cardiovascular, metabolic, cancer, respiratory, muscular); pregnancy; abdominoplasty; collum and gluteal surgeries; deregulated menstrual cycle ; anatomical changes; anticelulitic treatments

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Andreia Noites

    Vila Nova de Gaia, Porto District, 4400-303

Other trials in Portugal

About this study

Official title: Analyze the Relationship Between the Density of Abdominal Visceral and Subcutaneous Fat and Cellulite With the Lumbar

The aim of this study is analyze the relationship between the density of visceral and subcutaneous fat and cellulite with the lumbar lordosis degree.

Read the detailed description

There are two types of abdominal fat: subcutaneous adipose tissue which is more superficial, lying above the abdominal muscle wall and visceral adipose tissue, corresponding to the intra-abdominal fat witch is more harmful to health.

The accumulation of fat tissue differs between genders and age. Men have a huge propensity for developing central fat and women accumulate more subcutaneous fat tissue on the gluteal-femoral region. Some authors suggest that the accumulation of fat tissue increases with age.

Several studies have concluded that there is a relationship between the abdominal fat storage and the degree of lumbar curvature.

In addition, some authors also suggest that there is a relationship between the degree of lumbar lordosis and cellulite, which is related to circulatory changes.

However these relationships are not yet clarified in the literature.

Conditions
Lordosis
Being tested
Transversal Study so there is no intervention
Keywords
Central Fat, Subcutaneous Fat, Lumbar Lordosis Degree, Cellulite
Medical subject headings
Lordosis, Cellulite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transversal Study so there is no interventionOther

Study groups in NCT02903459
Study groupRoleWhat they receive
MalesEvaluation of body mass index, determination of waist-to-hip ration and waist-to-height ration, using perimetry; evaluation of 7 skinfold according to the model 7-site-skinfold Equation, by Jackson and Pollock, and photogrammetry (to evaluate the lumbar lordosis degree) in males aged between 18 and 26.
Receives: Other: Transversal Study so there is no intervention
Young AdultsEvaluation of abdominal thickness, percentage of abdominal fat and photogrammetry (to evaluate the lumbar lordosis degree) in young adults females aged between 18-26.
Receives: Other: Transversal Study so there is no intervention
AdultsEvaluation of abdominal thickness, percentage of abdominal fat and photogrammetry (to evaluate the lumbar lordosis degree) in adult females aged between 40-60.
Receives: Other: Transversal Study so there is no intervention
FemalesEvaluation of body mass index, determination of waist-to-hip ration and waist-to-height ration using perimetry, evaluation of 7 skinfold according to the model 7-site-skinfold Equation, by Jackson and Pollock, and photogrammetry (to evaluate the lumbar lordosis degree) in females aged between 18 and 26.
Receives: Other: Transversal Study so there is no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Lumbar Lordosis by analysing photos of the lateral right side of the participants

    We used photogrammetry for this evaluation. We marked the anatomical points (T11, L1, S2 and Antero-superior Iliac Spine) with isopod balls. We took a picture of the right lateral view of the participant. Finally we used the SAPo software to measure free angles to determinate lumbar lordosis degree.

    Measured: Day 1

Secondary outcomes (7)

  1. Body Mass Index

    The height was measured by a tape-measure. We used the bioimpedance balance to determinate the body mass of the participants. BMI was calculated by using the body weight divided by height squared.

    Measured: Day 1

  2. Perimeters measurements using a tape-measure at waist level and at trochanters level at the end of expiration

    The perimeters measurements were done at the end of expiration, at waist level and at trochanters level. The waist-hip ratio was calculated by using the waist level perimeter divided by trochanters level perimeter and the waist-to-height ratio was calculated by using the waist level perimeter divided by height

    Measured: Day 1

  3. Skinfold measures

    Subscapular, tricipital, chest, axillar, suprailiac, abdominal, thick skinfolds were performed three times in right hemibody, by caliper according to the model 7-site-skinfold Equation, by Jackson and Pollock. Siri equation was used to determinate the percentage of total body fat.

    Measured: Day 1

  4. Bioimpedance Balance

    This instrument was used to determine the weight, the percentage of body and abdominal fat, the visceral index and the percentage of body and abdominal lean mass.

    Measured: Day 1

  5. Ecograph

    It was used for distinguishing of abdominal thickness fat (differentiate the fat in visceral and subcutaneous fat tissue) and in order to obtain the thickness of the subcutaneous adipose tissue at the points of maximum and minimum temperature on the gluteal region.

    Measured: Day 1

  6. Thermography

    Measurement of skin temperature in the gluteal region to obtain the average, the minimum and the maximum temperature on this area.

    Measured: Day 1

  7. Cellulite Grading Scale

    6 Photos were taken in the posterior and lateral (right and left) views, 3 in relaxation and 3 in gluteal isometric contraction.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionOct 2016
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02903459
Sponsor's protocol ID
AN-005
Other IDs
AR, MS, MC
Status last verified
Mar 2018
First submitted
1 Aug 2016
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Jackson AS, Pollock ML. Generalized equations for predicting body density of men. Br J Nutr. 1978 Nov;40(3):497-504. doi: 10.1079/bjn19780152.

    PubMed 718832

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

  • Siqueira, G. R., Alencar, G. G., Rocha, M. B. N., Silva, L. R., Moura, M. C. G. G., & Silva, G. A. P. (2015). Relação entre lordose lombar e depósito de gordura abdominal em adolescentes e adultos jovens. Revista Brasileira de Ciência e Movimento, 74-80.

  • Power ML, Schulkin J. Sex differences in fat storage, fat metabolism, and the health risks from obesity: possible evolutionary origins. Br J Nutr. 2008 May;99(5):931-40. doi: 10.1017/S0007114507853347. Epub 2007 Nov 1.

    PubMed 17977473

  • Lopes C, Aro A, Azevedo A, Ramos E, Barros H. Intake and adipose tissue composition of fatty acids and risk of myocardial infarction in a male Portuguese community sample. J Am Diet Assoc. 2007 Feb;107(2):276-86. doi: 10.1016/j.jada.2006.11.008.

    PubMed 17258965

  • Kuo YL, Tully EA, Galea MP. Video analysis of sagittal spinal posture in healthy young and older adults. J Manipulative Physiol Ther. 2009 Mar-Apr;32(3):210-5. doi: 10.1016/j.jmpt.2009.02.002.

    PubMed 19362231

  • Bazzocchi A, Filonzi G, Ponti F, Sassi C, Salizzoni E, Battista G, Canini R. Accuracy, reproducibility and repeatability of ultrasonography in the assessment of abdominal adiposity. Acad Radiol. 2011 Sep;18(9):1133-43. doi: 10.1016/j.acra.2011.04.014. Epub 2011 Jul 2.

    PubMed 21724427

  • Noites A, Nunes R, Gouveia AI, Mota A, Melo C, Viera A, Adubeiro N, Bastos JM. Effects of aerobic exercise associated with abdominal microcurrent: a preliminary study. J Altern Complement Med. 2015 Apr;21(4):229-36. doi: 10.1089/acm.2014.0114.

    PubMed 25875939

  • Nkengne A, Papillon A, Bertin C. Evaluation of the cellulite using a thermal infra-red camera. Skin Res Technol. 2013 Feb;19(1):e231-7. doi: 10.1111/j.1600-0846.2012.00633.x. Epub 2012 Jun 29.

    PubMed 22741614

  • Goldman, M., & Hexsel, D. (2006). Cellulite: Pathophysiology and Treatment (i. healthcare Ed. 2ª edição ed.).

  • FLIR. (2013). Flir E-Series.

  • COMED. (2013). Company Comed.

  • Corporation, T. (2006). Tanita: Monitoring Your Heath. Tanita Manual: InnerScan Body Composition Monitor

Questions about this trial

What is this clinical trial studying?

An observational study of Lordosis, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluation of Lumbar Lordosis by analysing photos of the lateral right side of the participants (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02903459, which also lists 13 linked publications.

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 7 Mar 2018.

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