<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/NCT03000907</url>
  </required_header>
  <id_info>
    <org_study_id>60/16</org_study_id>
    <nct_id>NCT03000907</nct_id>
  </id_info>
  <brief_title>Efficacy of an Intervention to Prevent Frailty in Obese Elderly People (PRE-FROB)</brief_title>
  <acronym>PRE-FROB</acronym>
  <official_title>Efficacy of a Multimodal Intervention in the Prevention of Frailty in Obese Elderly People and Study of the Pathophysiological Mechanisms Involved</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Consorci Sanitari del Maresme</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Consorci Sanitari del Maresme</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>
      Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the&#xD;
      elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a&#xD;
      fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese&#xD;
      people usually perform less physical activity. All this favors the loss of mass and muscular&#xD;
      function (sarcopenia), a key component of the fragility and the functional deterioration.&#xD;
&#xD;
      Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the&#xD;
      prevention of frailty in obese elderly people, as well as to know the main mechanisms&#xD;
      involved in the frailty process.&#xD;
&#xD;
      Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel&#xD;
      intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of&#xD;
      age, obese (BMI ≥30), without criteria of fragility and living in the community. Study&#xD;
      intervention: multimodal and personalized intervention with the support of a &quot;personal&#xD;
      trainer&quot; that has two main axes of action: a) diet: assessment of nutritional status and&#xD;
      nutritional requirements and establishment of personalized nutritional plan with monthly&#xD;
      dietetic controls and b) physical exercise: a multi-component physical exercise program that&#xD;
      will include aerobic exercise and strengthening, balance and flexibility exercises as well as&#xD;
      a weekly group session of health education, during six months. Main outcome measures (to be&#xD;
      evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia&#xD;
      (according to the criteria of the European Working Group on Sarcopenia in Older People&#xD;
      -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip&#xD;
      strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance&#xD;
      (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in&#xD;
      body composition and distribution of body fat, c) glycemic control (HbA1) and insulin&#xD;
      resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according&#xD;
      to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute&#xD;
      Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis&#xD;
      Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">April 26, 2019</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frailty</measure>
    <time_frame>two years</time_frame>
    <description>Frailty by L Fried criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sarcopenia</measure>
    <time_frame>two years</time_frame>
    <description>Sarcopenia by European Working Group on Sarcopenia in Older People criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">319</enrollment>
  <condition>Fragility</condition>
  <condition>Sarcopenia</condition>
  <condition>Obese</condition>
  <condition>Elderly</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>diet: assessment of nutritional status and nutritional requirements and establishment of personalized nutritional plan with monthly dietetic controls.&#xD;
physical exercise: a multi-component physical exercise program that will include aerobic exercise and strengthening, balance and flexibility exercises as well as a weekly group session of health education, during six months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinical practise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Diet and physical exercises</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 30 and 39 kg / m2&#xD;
&#xD;
          -  Non Frail according to L. Fried criteria&#xD;
&#xD;
          -  At least one of the following diagnoses:&#xD;
&#xD;
               -  Oral glucose intolerance or type 2 diabetes without insulin therapy.&#xD;
&#xD;
               -  Dyslipidemia (cholesterolemia&gt; 200 mg / dl or triglyceridemia&gt; 150 mg / dl)&#xD;
&#xD;
               -  Arterial hypertension (AT&gt; 120/90 mm Hg)&#xD;
&#xD;
               -  Relevant physical limitations due to obesity&#xD;
&#xD;
               -  Sleep apnea-hypopnea syndrome (SAHS)&#xD;
&#xD;
          -  Give written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia or other neurodegenerative diseases (Parkinson's disease)&#xD;
&#xD;
          -  Neuromuscular diseases&#xD;
&#xD;
          -  Severe psychiatric illness that, at the discretion of the physician, prevents good&#xD;
             compliance with the study intervention&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Life expectancy less than 6 months&#xD;
&#xD;
          -  Hemiplegia secondary to stroke&#xD;
&#xD;
          -  Amputation of a member&#xD;
&#xD;
          -  Bariatric surgery tributary patient&#xD;
&#xD;
          -  Institutionalized patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Consorci Sanitari del Maresme</name>
      <address>
        <city>Mataró</city>
        <state>Barcelona</state>
        <zip>08304</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prevention</keyword>
  <keyword>frailty</keyword>
  <keyword>obese</keyword>
  <keyword>elderly</keyword>
  <keyword>physical exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03000907
org study id: 60/16
nct id: NCT03000907
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the
      elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a
      fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese
      people usually perform less physical activity. All this favors the loss of mass and muscular
      function (sarcopenia), a key component of the fragility and the functional deterioration.

      Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the
      prevention of frailty in obese elderly people, as well as to know the main mechanisms
      involved in the frailty process.

      Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel
      intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of
      age, obese (BMI ≥30), without criteria of fragility and living in the community. Study
      intervention: multimodal and personalized intervention with the support of a "personal
      trainer" that has two main axes of action: a) diet: assessment of nutritional status and
      nutritional requirements and establishment of personalized nutritional plan with monthly
      dietetic controls and b) physical exercise: a multi-component physical exercise program that
      will include aerobic exercise and strengthening, balance and flexibility exercises as well as
      a weekly group session of health education, during six months. Main outcome measures (to be
      evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia
      (according to the criteria of the European Working Group on Sarcopenia in Older People
      -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip
      strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance
      (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in
      body composition and distribution of body fat, c) glycemic control (HbA1) and insulin
      resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according
      to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute
      Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis
      Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Frailty
time frame: two years
description: Frailty by L Fried criteria
measure: Sarcopenia
time frame: two years
description: Sarcopenia by European Working Group on Sarcopenia in Older People criteria
arm group label: Intervention
arm group type: Experimental
description: diet: assessment of nutritional status and nutritional requirements and establishment of personalized nutritional plan with monthly dietetic controls.
physical exercise: a multi-component physical exercise program that will include aerobic exercise and strengthening, balance and flexibility exercises as well as a weekly group session of health education, during six months.
arm group label: Control
arm group type: No Intervention
description: Clinical practise
intervention type: Other
intervention name: Intervention
description: Diet and physical exercises
arm group label: Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Sarcopenia
mesh term: Frailty
sharing ipd: No