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Trial record 61 of 93 for:    high | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

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

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ClinicalTrials.gov Identifier: NCT03338868
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Metabolic Syndrome Other: Body composition Other: Physical activity level Other: Musculoskeletal pain intensity Other: Quality of life Other: Psychological Well-Being Diagnostic Test: Blood tests

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Comparison of Serum Concentrations, Physical and Psychological Well-being in Patients Having Chronic Musculoskeletal Pain With and Without Metabolic Syndrome
Actual Study Start Date : August 1, 2015
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Body composition
evaluated by Bodystat®1500 Bio-impedance Analyzer

Other: Physical activity level
assessed by the International Physical Activity Questionnaire-7

Other: Musculoskeletal pain intensity
evaluated with Visual Analog Scale

Other: Quality of life
assessed by the Nottingham Health Profile

Other: Psychological Well-Being
assessed by the Hospital Anxiety and Depression Scale

Diagnostic Test: 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.

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.
Other: Body composition
evaluated by Bodystat®1500 Bio-impedance Analyzer

Other: Physical activity level
assessed by the International Physical Activity Questionnaire-7

Other: Musculoskeletal pain intensity
evaluated with Visual Analog Scale

Other: Quality of life
assessed by the Nottingham Health Profile

Other: Psychological Well-Being
assessed by the Hospital Anxiety and Depression Scale

Diagnostic Test: 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.




Primary Outcome Measures :
  1. Blood tests [ Time Frame: 2 years ]
    for uric acid levels.


Secondary Outcome Measures :
  1. Body composition [ Time Frame: 2 years ]
    evaluated by Bodystat®1500 Bio-impedance Analyzer

  2. Physical activity level [ Time Frame: 2 years ]
    assessed by the International Physical Activity Questionnaire-7. The intensity of self-reported physical activity, lasting at ten minutes per bout, was used to assess metabolic equivalent (MET). The MET is defined as the ratio of a working metabolic rate to a standard resting metabolic rate.MET-minutes/week was computed by multiplying the MET score of an activity (3.3 for walking, 4.0 for moderate-intensity, and 8.0 for vigorous-intensity) by the minutes and days performed. The summation of walking, moderate, and vigorous METs-minutes/week enabled the computation of the total physical activity performed by an individual.

  3. The musculoskeletal pain intensity [ Time Frame: 2 years ]
    evaluated with 0 to 10 cm Visual Analog Scale. "0" indicated "no pain" and the "10" indicated "the worst imaginable pain".

  4. Quality of life [ Time Frame: 2 years ]
    evaluated with the Nottingham Health Profile (NHP). It contains 38 items divided into 6 dimensions: NHP-energy, NHP-pain, NHP-emotional reactions, NHP sleep, NHP-social isolation, and NHP-physical mobility. All the parameters are summed as NHP-total. The respondent answers "yes" if the statement adequately reflected the current status or feeling, or "no" otherwise. Dimension scores ranged from 0 (no problems) to 100 (maximum problems).

  5. Psychological Well-Being (Anxiety and Deppression condition) [ Time Frame: 2 years ]
    evaluated with the Hospital Anxiety and Depression Scale (HADS). Each question was scored on a 4-point Likert scale, ranging from 0 to 3, where a higher score represented more severe anxiety or depression.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients having chronic musculoskeletal pain with and without metabolic syndrome
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338868


Contacts
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Contact: Seyda Toprak Celenay, Asist Prof +90 530 041 3986 sydtoprak@hotmail.com

Locations
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Turkey
Ataturk Training and Research Hospital Active, not recruiting
Ankara, Cankaya, Turkey, 06800
Ataturk Training and Research Hospital Recruiting
Ankara, Cankaya, Turkey, 06800
Contact: Seyda Toprak Celenay, Assist Prof    +90 530 041 39 86    sydtoprak@hotmail.com   
Sponsors and Collaborators
Ataturk Training and Research Hospital
Investigators
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Study Director: Seyda Toprak Celenay, Assist prof Ankara Yildirim Beyazit University Ataturk Training and Research Hospital

Additional Information:

Publications of Results:
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Responsible Party: Seyda TOPRAK CELENAY, Assistant Professor, PT, PhD, Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03338868     History of Changes
Other Study ID Numbers: 2015-13/32
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital:
physical activity
pain
uric acid

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases