<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/NCT02218905</url>
  </required_header>
  <id_info>
    <org_study_id>13/311</org_study_id>
    <nct_id>NCT02218905</nct_id>
  </id_info>
  <brief_title>Normative Values and Forming Regression Equations for One Minute Sit to Stand Test in Healthy Normal Indian Population</brief_title>
  <acronym>1minSTS</acronym>
  <official_title>Phase 0 Study of Reference Values for One Minute Sit to Stand Test in Healthy Indian Population - a Cross Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskaran Chandrasekaran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PSG Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PSG Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to find relation between number of repetitions the volunteer able to sit and&#xD;
      stand in an armless chair and their age, height, weight and gender. The investigators&#xD;
      hypothesis there is a moderate relation between anthropometric characteristics and number of&#xD;
      situps. This may partially define the ability of functional capacity and quadriceps ability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sit to stand is gaining importance as a functional capacity measurement tool in modern&#xD;
      chronic diseases arena. Bu the reference values for normative population is not available.&#xD;
      Hence the present study aimed at finding relation between the anthropometric variables (age,&#xD;
      height, weight) and number of sit to stand repetitions. The volunteers will be asked to sit&#xD;
      to stand in an arm less chair of 40 inches height. The number of repetition will be&#xD;
      correlated and regression equations will be sought out relating number of repetitions and&#xD;
      anthropometric variables through best fit regression equations&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of repetitions of sit ups within 60 seconds</measure>
    <time_frame>baseline, 1.5 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate recovery (in seconds)</measure>
    <time_frame>1 minute</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure (mmHg)</measure>
    <time_frame>baseline, 1 minute</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>saturation (%)</measure>
    <time_frame>baseline, 0.5 minute, 1 minute</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate (beats/ min)</measure>
    <time_frame>baseline, 0.5 minute, 1 minute</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Anthropometric variables</measure>
    <time_frame>Baseline</time_frame>
    <description>Age, height, weight of the volunteers</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">196</enrollment>
  <condition>Human Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Sit to stand test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One minute sit to stand in 40 inches armless chair. Fatigue, breathlessness and failure to maintain tempo will lead to decease the test</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sit to stand test</intervention_name>
    <description>Subjects will be asked to sit to stand in 40 inches chair for 60 seconds.</description>
    <arm_group_label>Sit to stand test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  30 - 80 years old&#xD;
&#xD;
          -  Hospital staffs, relatives of patients volunteering the test&#xD;
&#xD;
          -  Willing to give consent for the test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic cardiovascular and pulmonary diseases&#xD;
&#xD;
          -  On anticoagulants&#xD;
&#xD;
          -  Cancer undergoing chemo, radiotherapy&#xD;
&#xD;
          -  recent orthopaedic ailments (Osteoarthritis, Rheumatoid arthritis, surgeries less than&#xD;
             3 months)&#xD;
&#xD;
          -  Balance impairments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RM PL Ramanathan, MD DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>PSG Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PSG Hospitals</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamilnadu</state>
        <zip>641004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 29, 2014</last_update_submitted>
  <last_update_submitted_qc>August 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>PSG Hospitals</investigator_affiliation>
    <investigator_full_name>Baskaran Chandrasekaran</investigator_full_name>
    <investigator_title>Senior Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Correlation</keyword>
  <keyword>Sit to stand repetitions</keyword>
  <keyword>Anthropometric variables</keyword>
  <keyword>Age</keyword>
  <keyword>Height</keyword>
  <keyword>weight</keyword>
  <keyword>Gender</keyword>
  <keyword>Regression</keyword>
  <!-- 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/NCT02218905
org study id: 13/311
nct id: NCT02218905
lead sponsor: 
collaborator: 
has dmc: Yes
This study is to find relation between number of repetitions the volunteer able to sit and
      stand in an armless chair and their age, height, weight and gender. The investigators
      hypothesis there is a moderate relation between anthropometric characteristics and number of
      situps. This may partially define the ability of functional capacity and quadriceps ability.
Sit to stand is gaining importance as a functional capacity measurement tool in modern
      chronic diseases arena. Bu the reference values for normative population is not available.
      Hence the present study aimed at finding relation between the anthropometric variables (age,
      height, weight) and number of sit to stand repetitions. The volunteers will be asked to sit
      to stand in an arm less chair of 40 inches height. The number of repetition will be
      correlated and regression equations will be sought out relating number of repetitions and
      anthropometric variables through best fit regression equations
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of repetitions of sit ups within 60 seconds
time frame: baseline, 1.5 minutes
measure: heart rate recovery (in seconds)
time frame: 1 minute
measure: blood pressure (mmHg)
time frame: baseline, 1 minute
measure: saturation (%)
time frame: baseline, 0.5 minute, 1 minute
measure: Heart rate (beats/ min)
time frame: baseline, 0.5 minute, 1 minute
measure: Anthropometric variables
time frame: Baseline
description: Age, height, weight of the volunteers
arm group label: Sit to stand test
arm group type: Experimental
description: One minute sit to stand in 40 inches armless chair. Fatigue, breathlessness and failure to maintain tempo will lead to decease the test
intervention type: Behavioral
intervention name: Sit to stand test
description: Subjects will be asked to sit to stand in 40 inches chair for 60 seconds.
arm group label: Sit to stand test
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: RM PL Ramanathan, MD DM
role: Principal Investigator
affiliation: PSG Hospitals
facility: 
country: India
responsible party type: Sponsor-Investigator
investigator affiliation: PSG Hospitals
investigator full name: Baskaran Chandrasekaran
investigator title: Senior Physiotherapist