Serum Concentrations, Physical and Psychological Well-being in Metabolic Syndrome

NCT ID: NCT03338868

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-12-30

Brief Summary

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The purpose of this study was to investigate the serum concentrations, physical and psychological well-being characteristics in patients having chronic musculoskeletal pain with metabolic syndrome, and to compare patients without metabolic syndrome.

Detailed Description

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Metabolic syndrome (MetS) is a combination of metabolic risk factors such as impaired glucose level, dyslipidemia, hypertension, and central obesity. MetS has become a large public health issue with common interrelation to different accompanying disorders. Moreover, the link between MetS and musculoskeletal disorders has previously been demonstrated.

Presence and prevalence of MetS in patients having musculoskeletal pain seems common and interrelated.However, to our knowledge, manifestations with clinical symptoms of MetS, some inflammatory markers via serum concentrations and physical and psychological health profiles of patients with seeking treatment from outpatient physical therapy for musculoskeletal pain conditions have not been researched up to now.

Conditions

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Metabolic Syndrome

Keywords

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physical activity pain uric acid

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with MetS

To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months.

Body composition

Intervention Type OTHER

evaluated by Bodystat®1500 Bio-impedance Analyzer

Physical activity level

Intervention Type OTHER

assessed by the International Physical Activity Questionnaire-7

Musculoskeletal pain intensity

Intervention Type OTHER

evaluated with Visual Analog Scale

Quality of life

Intervention Type OTHER

assessed by the Nottingham Health Profile

Psychological Well-Being

Intervention Type OTHER

assessed by the Hospital Anxiety and Depression Scale

Blood tests

Intervention Type DIAGNOSTIC_TEST

Blood tests included serum glucose, triglyceride, high-density lipoprotein cholesterol (HDL-C), and uric acid levels. Blood samples were collected from the patients after one night of fasting.

Patients without MetS

To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months.

Body composition

Intervention Type OTHER

evaluated by Bodystat®1500 Bio-impedance Analyzer

Physical activity level

Intervention Type OTHER

assessed by the International Physical Activity Questionnaire-7

Musculoskeletal pain intensity

Intervention Type OTHER

evaluated with Visual Analog Scale

Quality of life

Intervention Type OTHER

assessed by the Nottingham Health Profile

Psychological Well-Being

Intervention Type OTHER

assessed by the Hospital Anxiety and Depression Scale

Blood tests

Intervention Type DIAGNOSTIC_TEST

Blood tests included serum glucose, triglyceride, high-density lipoprotein cholesterol (HDL-C), and uric acid levels. Blood samples were collected from the patients after one night of fasting.

Interventions

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Body composition

evaluated by Bodystat®1500 Bio-impedance Analyzer

Intervention Type OTHER

Physical activity level

assessed by the International Physical Activity Questionnaire-7

Intervention Type OTHER

Musculoskeletal pain intensity

evaluated with Visual Analog Scale

Intervention Type OTHER

Quality of life

assessed by the Nottingham Health Profile

Intervention Type OTHER

Psychological Well-Being

assessed by the Hospital Anxiety and Depression Scale

Intervention Type OTHER

Blood tests

Blood tests included serum glucose, triglyceride, high-density lipoprotein cholesterol (HDL-C), and uric acid levels. Blood samples were collected from the patients after one night of fasting.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months.

Exclusion Criteria

the presence of severe physical disability, psychiatric disorder, malignant tumors, pregnancy, chronic alcohol consumption, gout, heart failure, liver and renal dysfunction.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seyda TOPRAK CELENAY

Assistant Professor, PT, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyda Toprak Celenay, Assist prof

Role: STUDY_DIRECTOR

Ankara Yildirim Beyazit University Ataturk Training and Research Hospital

Locations

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Ataturk Training and Research Hospital

Ankara, Cankaya, Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Ataturk Training and Research Hospital

Ankara, Cankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Seyda Toprak Celenay, Asist Prof

Role: CONTACT

Phone: +90 530 041 3986

Email: [email protected]

Facility Contacts

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Seyda Toprak Celenay, Assist Prof

Role: primary

References

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Afzal N, Mahmud TE, Jahan SS, Kundi S. Uric acid profile in patients with chronic nonspecific musculoskeletal pain. J Ayub Med Coll Abbottabad. 2003 Oct-Dec;15(4):5-9.

Reference Type RESULT
PMID: 15067822 (View on PubMed)

Fu YQ, Yang H, Zheng JS, Zeng XY, Zeng W, Fan ZF, Chen M, Wang L, Li D. Positive association between metabolic syndrome and serum uric acid in Wuhan. Asia Pac J Clin Nutr. 2017 Mar;26(2):343-350. doi: 10.6133/apjcn.012016.06.

Reference Type RESULT
PMID: 28244715 (View on PubMed)

Chu AH, Moy FM. Association between physical activity and metabolic syndrome among Malay adults in a developing country, Malaysia. J Sci Med Sport. 2014 Mar;17(2):195-200. doi: 10.1016/j.jsams.2013.04.003. Epub 2013 May 9.

Reference Type RESULT
PMID: 23665093 (View on PubMed)

Saboya PP, Bodanese LC, Zimmermann PR, Gustavo AD, Assumpcao CM, Londero F. Metabolic syndrome and quality of life: a systematic review. Rev Lat Am Enfermagem. 2016 Nov 28;24:e2848. doi: 10.1590/1518-8345.1573.2848.

Reference Type RESULT
PMID: 27901223 (View on PubMed)

Takeuchi T, Nakao M, Nomura K, Inoue M, Tsurugano S, Shinozaki Y, Yano E. Association of the metabolic syndrome with depression and anxiety in Japanese men: a 1-year cohort study. Diabetes Metab Res Rev. 2009 Nov;25(8):762-7. doi: 10.1002/dmrr.1041.

Reference Type RESULT
PMID: 19839027 (View on PubMed)

Other Identifiers

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2015-13/32

Identifier Type: -

Identifier Source: org_study_id