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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05974514
Other study ID # 29.12.2022/141
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 10, 2023
Est. completion date September 10, 2023

Study information

Verified date March 2024
Source Fenerbahce University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to examine the level of body awareness in individuals with obesity and investigate the parameters associated with body awareness. In addition, compare these parameters with healthy subjects with normal weight. The main questions it aims to answer are: - How is body awareness affected compared to healthy individuals? - Is physical activity level, dynamic balance, proprioception, and reaction time related to body awareness in individuals with obesity? - Is there any difference between obese and normal-weight individuals in terms of physical activity level, dynamic balance, proprioception, and reaction time?


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 10, 2023
Est. primary completion date September 8, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Adults with obesity ((BMI) = 30 kg/m2) aged 18-65 years, who did not receive obesity-related treatment 6 months before the study - Healthy adults with normal weight (BMI: 18.5-24.9 kg/m2). Exclusion Criteria: - Musculoskeletal, neurological, and rheumatological disorders (fractures, sprains or strains, spine surgery, advanced respiratory or orthopaedic problems), - Malignancy and pregnancy within the last 12 months, which might interfere with evaluations

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Marmara University Maltepe

Sponsors (1)

Lead Sponsor Collaborator
Fenerbahce University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Baert IAC, Lluch E, Struyf T, Peeters G, Van Oosterwijck S, Tuynman J, Rufai S, Struyf F. Inter- and intrarater reliability of two proprioception tests using clinical applicable measurement tools in subjects with and without knee osteoarthritis. Musculoskelet Sci Pract. 2018 Jun;35:105-109. doi: 10.1016/j.msksp.2017.11.011. Epub 2017 Nov 21. Erratum In: Musculoskelet Sci Pract. 2023 Feb;63:102683. — View Citation

Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192. — View Citation

Healey EL, Allen KD, Bennell K, Bowden JL, Quicke JG, Smith R. Self-Report Measures of Physical Activity. Arthritis Care Res (Hoboken). 2020 Oct;72 Suppl 10(Suppl 10):717-730. doi: 10.1002/acr.24211. No abstract available. — View Citation

Jung K, Kim Y, Chung Y, Hwang S. Weight-shift training improves trunk control, proprioception, and balance in patients with chronic hemiparetic stroke. Tohoku J Exp Med. 2014 Mar;232(3):195-9. doi: 10.1620/tjem.232.195. — View Citation

Karaca S, Bayar B. Turkish version of body awareness questionnaire: validity and reliability study. Türk Fizyoterapi ve Rehabilitasyon Dergisi. 2021;32(1):44-50.

Romero-Franco N, Montano-Munuera JA, Fernandez-Dominguez JC, Jimenez-Reyes P. Validity and Reliability of a Digital Inclinometer to Assess Knee Joint Position Sense in an Open Kinetic Chain. J Sport Rehabil. 2019 May 1;28(4):332-338. doi: 10.1123/jsr.2017-0221. Epub 2018 Dec 12. — View Citation

Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284. — View Citation

Tamer K. Sporda fizyolojik fiziksel performansin ölçülmesi ve degerlendirilmesi. Ankara: Bagirgan Yayimevi; 2000

Outcome

Type Measure Description Time frame Safety issue
Primary Body Awareness The Body Awareness Questionnaire will be used to assess body awareness. This questionnaire includes physical, emotional, and social aspects of a person's susceptibility to normal or abnormal bodily conditions and processes, questioning susceptibility to physical reactions. There are 18 statements in the questionnaire, each scored between 1 and 7 points (1=Not at all suitable for me, 7=Completely suitable for me). The total score is 126 and higher indicates a better body awareness level. Baseline (Only 1 time)
Secondary Physical activity level To evaluate self-reported physical activity level, International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used. The IPAQ-SF (7 questions) provides information about time spent on walking, moderate-intensity, and vigorous-intensity activities, as well as time spent sitting. The energy MET-minute score for these activities is calculated using standard MET values, which are as follows: Sitting: 1.5 MET, walking: 3.3 MET, moderate-intensity physical activity: 4.0 MET, vigorous-intensity physical activity: 8.0 MET.
The total MET minutes per week are determined by taking the provided MET value and multiplying it by the total minutes spent engaging in the activity each day. Then, the MET minutes for all the days that the particular activity was performed are added up. Finally, the MET minutes from different activities are added up to get the total MET minutes per week. Physical activity level is categorized as low, moderate, and high.
Baseline (Only 1 time)
Secondary Dynamic balance Dynamic balance will be evaluated with the functional reach test. In this test, when standing upright, the distance covered by an extended arm during a complete forward reach, while ensuring a fixed supporting stance is measured. Baseline (Only 1 time)
Secondary Proprioception The joint position sense assessment will be conducted using a Baseline bubble inclinometer to evaluate proprioception. Baseline (Only 1 time)
Secondary Reaction time The Nelson Foot Reaction Test will be used to evaluate individuals' reaction speed. Baseline (Only 1 time)
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