xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06004427</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar74</org_study_id>
      <nct_id>NCT06004427</nct_id>
    </id_info>
    <brief_title>Investigation of the Effectiveness of Resistance Exercise Program Given With Diet in Obese Individuals.</brief_title>
    <official_title>Investigation of the Effectiveness of Resistance Exercise Program Given With Diet in Obese Individuals.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to examine the effects of diet and combined resistance exercise&#xD;
        training on physical activity and sleep patterns compared to diet program alone.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was planned as a randomized controlled trial. The groups will be divided into two&#xD;
        as control group and exercise group by simple randomization method.While the normal diet&#xD;
        program will be applied to the obese individuals in the control group, the individuals in the&#xD;
        exercise group will be given resistance exercise training together with the diet&#xD;
        program.Before and after the treatment, fatigue severity scale pittsburgh sleep quality scale&#xD;
        international physical activity index questionnaires will be applied to the participants.In&#xD;
        addition, sociodemographic characteristics and waist circumference measurement will be&#xD;
        recorded. After the 12-week diet program, the data of the participants will be compared by&#xD;
        making statistical analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>resistance training (RT), (3 days/wk, 3 sets/day, 8-12 repetitions/set)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>13 weeks</time_frame>
      <description>The scale is a 19-item self-report scale that assesses sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates &quot;poor sleep quality&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue Severity Scale (FSS)</measure>
      <time_frame>13 weeks</time_frame>
      <description>There are 9 questions in the scale and each question consists of 7 points. The scale determines the fatigue status of individuals in the last 1 month. Questions are scored as Strongly disagree - Totally agree. The scale score is the average value of the questions. If the average score is 5 and above, it is considered as &quot;fatigue&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International Physical Activity Questionnaire - Short Form</measure>
      <time_frame>13 weeks</time_frame>
      <description>This questionnaire is a standardized tool for measuring physical activity, developed by researchers from various countries with the support of the World Health Organization (WHO) and Centers for Disease Control (CDC). Questionnaire, four areas of physical activity; It covers work, transportation, housework/gardening, and leisure activities, but also includes questions about time spent sitting as an indicator of inactivity. In each of the four areas, the energy expended in moderate and vigorous activities in the last 7 days, the number of days the activities were performed, and the number of activities performed during the day are recorded. The times are multiplied by the Metabolic Equivalent (MET) values per activity, and the results for all items are added to form the overall physical activity score. The question about sitting is not included in the physical activity score. Classification is made in three categories as physically inactive (3000 MET min/week).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>regular diet program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>resistance exercise program</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Diet program</intervention_name>
      <description>A diet program will be prepared with the help of a dietitian at the beginning of 12 weeks for all participants who agree to participate in the study, and this program will be controlled by a dietitian once a month and completed at the end of 12 weeks.</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>exercise group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise training protocols</intervention_name>
      <description>calisthenic exercises exercises with lower and upper extremity theraband exercises with light dumbbells</description>
      <arm_group_label>exercise group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  be 18 years or older.&#xD;
  &#xD;
            -  Having a Body Mass Index of 30 or higher.&#xD;
  &#xD;
            -  To have accepted the voluntary consent form that requires participation in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any neurological or psychological problems.&#xD;
  &#xD;
            -  Do not accept the voluntary consent form.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alara Livanur ÇELİK</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Üsküdar Unıversıty</name>
        <address>
          <city>Üsküdar</city>
          <state>İstanbul</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Waters DL, Aguirre L, Gurney B, Sinacore DR, Fowler K, Gregori G, Armamento-Villareal R, Qualls C, Villareal DT. Effect of Aerobic or Resistance Exercise, or Both, on Intermuscular and Visceral Fat and Physical and Metabolic Function in Older Adults With Obesity While Dieting. J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):131-139. doi: 10.1093/gerona/glab111.</citation>
      <PMID>33839788</PMID>
    </reference>
    <reference>
      <citation>Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Sweeney FC, Stewart C, Buchanan TA, Spicer D, Tripathy D, Bernstein L, Mortimer JE. Aerobic and resistance exercise improves physical fitness, bone health, and quality of life in overweight and obese breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2018 Oct 19;20(1):124. doi: 10.1186/s13058-018-1051-6.</citation>
      <PMID>30340503</PMID>
    </reference>
    <reference>
      <citation>Soriano-Maldonado A, Martinez-Forte S, Ferrer-Marquez M, Martinez-Rosales E, Hernandez-Martinez A, Carretero-Ruiz A, Villa-Gonzalez E, Barranco-Ruiz Y, Rodriguez-Perez MA, Torrente-Sanchez MJ, Carmona-Rodriguez L, Soriano-Maldonado P, Vargas-Hitos JA, Casimiro-Andujar AJ, Artero EG, Fernandez-Alonso AM. Physical Exercise following bariatric surgery in women with Morbid obesity: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Mar;99(12):e19427. doi: 10.1097/MD.0000000000019427.</citation>
      <PMID>32195937</PMID>
    </reference>
    <reference>
      <citation>Villareal DT, Aguirre L, Gurney AB, Waters DL, Sinacore DR, Colombo E, Armamento-Villareal R, Qualls C. Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults. N Engl J Med. 2017 May 18;376(20):1943-1955. doi: 10.1056/NEJMoa1616338.</citation>
      <PMID>28514618</PMID>
    </reference>
    <reference>
      <citation>Willis LH, Slentz CA, Bateman LA, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Effects of aerobic and/or resistance training on body mass and fat mass in overweight or obese adults. J Appl Physiol (1985). 2012 Dec 15;113(12):1831-7. doi: 10.1152/japplphysiol.01370.2011. Epub 2012 Sep 27.</citation>
      <PMID>23019316</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <keyword>resistant exercise</keyword>
    <keyword>diet</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06004427
  org study id: Uskudar74
  nct id: NCT06004427
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to examine the effects of diet and combined resistance exercise
        training on physical activity and sleep patterns compared to diet program alone.
  The study was planned as a randomized controlled trial. The groups will be divided into two
        as control group and exercise group by simple randomization method.While the normal diet
        program will be applied to the obese individuals in the control group, the individuals in the
        exercise group will be given resistance exercise training together with the diet
        program.Before and after the treatment, fatigue severity scale pittsburgh sleep quality scale
        international physical activity index questionnaires will be applied to the participants.In
        addition, sociodemographic characteristics and waist circumference measurement will be
        recorded. After the 12-week diet program, the data of the participants will be compared by
        making statistical analysis.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: resistance training (RT), (3 days/wk, 3 sets/day, 8-12 repetitions/set)
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The Pittsburgh Sleep Quality Index (PSQI)
  time frame: 13 weeks
  description: The scale is a 19-item self-report scale that assesses sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"
  measure: Fatigue Severity Scale (FSS)
  time frame: 13 weeks
  description: There are 9 questions in the scale and each question consists of 7 points. The scale determines the fatigue status of individuals in the last 1 month. Questions are scored as Strongly disagree - Totally agree. The scale score is the average value of the questions. If the average score is 5 and above, it is considered as "fatigue".
  measure: International Physical Activity Questionnaire - Short Form
  time frame: 13 weeks
  description: This questionnaire is a standardized tool for measuring physical activity, developed by researchers from various countries with the support of the World Health Organization (WHO) and Centers for Disease Control (CDC). Questionnaire, four areas of physical activity; It covers work, transportation, housework/gardening, and leisure activities, but also includes questions about time spent sitting as an indicator of inactivity. In each of the four areas, the energy expended in moderate and vigorous activities in the last 7 days, the number of days the activities were performed, and the number of activities performed during the day are recorded. The times are multiplied by the Metabolic Equivalent (MET) values per activity, and the results for all items are added to form the overall physical activity score. The question about sitting is not included in the physical activity score. Classification is made in three categories as physically inactive (3000 MET min/week).
  arm group label: control group
  arm group type: Active Comparator
  description: regular diet program
  arm group label: exercise group
  arm group type: Experimental
  description: resistance exercise program
  intervention type: Other
  intervention name: Diet program
  description: A diet program will be prepared with the help of a dietitian at the beginning of 12 weeks for all participants who agree to participate in the study, and this program will be controlled by a dietitian once a month and completed at the end of 12 weeks.
  arm group label: control group
  arm group label: exercise group
  intervention type: Other
  intervention name: Exercise training protocols
  description: calisthenic exercises exercises with lower and upper extremity theraband exercises with light dumbbells
  arm group label: exercise group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alara Livanur ÇELİK
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  country: Turkey
  citation: Waters DL, Aguirre L, Gurney B, Sinacore DR, Fowler K, Gregori G, Armamento-Villareal R, Qualls C, Villareal DT. Effect of Aerobic or Resistance Exercise, or Both, on Intermuscular and Visceral Fat and Physical and Metabolic Function in Older Adults With Obesity While Dieting. J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):131-139. doi: 10.1093/gerona/glab111.
  PMID: 33839788
  citation: Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Sweeney FC, Stewart C, Buchanan TA, Spicer D, Tripathy D, Bernstein L, Mortimer JE. Aerobic and resistance exercise improves physical fitness, bone health, and quality of life in overweight and obese breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2018 Oct 19;20(1):124. doi: 10.1186/s13058-018-1051-6.
  PMID: 30340503
  citation: Soriano-Maldonado A, Martinez-Forte S, Ferrer-Marquez M, Martinez-Rosales E, Hernandez-Martinez A, Carretero-Ruiz A, Villa-Gonzalez E, Barranco-Ruiz Y, Rodriguez-Perez MA, Torrente-Sanchez MJ, Carmona-Rodriguez L, Soriano-Maldonado P, Vargas-Hitos JA, Casimiro-Andujar AJ, Artero EG, Fernandez-Alonso AM. Physical Exercise following bariatric surgery in women with Morbid obesity: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Mar;99(12):e19427. doi: 10.1097/MD.0000000000019427.
  PMID: 32195937
  citation: Villareal DT, Aguirre L, Gurney AB, Waters DL, Sinacore DR, Colombo E, Armamento-Villareal R, Qualls C. Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults. N Engl J Med. 2017 May 18;376(20):1943-1955. doi: 10.1056/NEJMoa1616338.
  PMID: 28514618
  citation: Willis LH, Slentz CA, Bateman LA, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Effects of aerobic and/or resistance training on body mass and fat mass in overweight or obese adults. J Appl Physiol (1985). 2012 Dec 15;113(12):1831-7. doi: 10.1152/japplphysiol.01370.2011. Epub 2012 Sep 27.
  PMID: 23019316
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: assistant professor