<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/NCT03798873</url>
  </required_header>
  <id_info>
    <org_study_id>FeelWell2018</org_study_id>
    <nct_id>NCT03798873</nct_id>
  </id_info>
  <brief_title>Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35</brief_title>
  <official_title>Examining the Impact of the Use of a Custom-fitted, FeelWell™ Compression Garment to Improve the Quality of Life of Individuals With a BMI ≥35</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Feelwell Compression</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Washington Center for Weight Management and Research, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Feelwell Compression</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the effect of wearing a custom-fitted, FDA-registered, Class I device, compression&#xD;
      garment (Obesinov, S.A.R.L.) by an individual with a BMI ≥ 35 on his/her day-to-day quality&#xD;
      of life over a period of one year. Various measures of quality of life will be taken,&#xD;
      including assessing an individual's level of pain, mood, self-stigma and comfort with the use&#xD;
      of a compression garment. Additionally, to assess the impact of the compression garment on&#xD;
      activity, strength, posture and movement of an individual with a BMI ≥35 over the period of&#xD;
      one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals suffering with obesity often experience daily pain and discomfort which limits&#xD;
      movement, a critical factor in managing weight, cardio-metabolic health, mood, sleep,&#xD;
      self-esteem and ultimately overall quality of life. Many individuals who experience weight&#xD;
      gain have an abdominal or central distribution of weight which affects body mechanics leading&#xD;
      to back pain, poor posture, difficulty walking with altered gait, knee, foot, ankle and leg&#xD;
      pain (IT band, meralgia paresthetica) and other non-specific chronic pain. Chronic pain&#xD;
      impedes mobility often incorporating depression and low motivation in an endless cycle.&#xD;
      Furthermore, as individuals are losing weight, they often suffer from excess skin which also&#xD;
      aggravates by chafing (arms, inner thighs), hanging down and interfering with gait.&#xD;
&#xD;
      The Investigators will examine the effect of wearing a custom-fitted, FDA-registered, Class I&#xD;
      device, compression garment (Obesinov, S.A.R.L.) by participants with a BMI ≥ 35 on&#xD;
      day-to-day quality of life over a period of one year. Various measures of quality of life&#xD;
      will be taken, including assessing the participant's level of pain, mood, self-stigma and&#xD;
      comfort with the use of a compression garment. Additional assessments include impact of the&#xD;
      compression garment on activity, strength, posture and movement as well as potential impact&#xD;
      of the use of this garment on weight loss and change in laboratory measures of metabolic&#xD;
      health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 13, 2019</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>Test group treated with the FeelWell™ Compression garment and control group without compression garment. All subjects will receive the same intervention working with exercise physiologist and physical therapist in order to improve mobility.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6- minute walk test- distance walked</measure>
    <time_frame>baseline, 1, 3, 6 and 12 months</time_frame>
    <description>6-min walk test is a sub-maximal exercise test measuring the total distance walked by a subject in a period of 6 minutes to assess functional capacity of a subject's cardio-respiratory systems and reflects their ability to perform Activities of Daily Living. Total distance walked will be measured and change recorded from baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>6- minute walk test- Perceived exertion</measure>
    <time_frame>baseline, 1, 3, 6 and 12 months</time_frame>
    <description>The Borg Rate of Perceived Exertion scale of 1-10 will be used for the subject to record their exertion level from 1 (no exertion)-10 (maximal exertion) and change will be noted from baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SF-36 physical component sub-score</measure>
    <time_frame>baseline, 3, 6 and 12 months</time_frame>
    <description>SF-36 consists of 8 sub-scales of health-related quality of life measuring various aspects of functioning. The summary score for physical component includes physical functioning, physical role, bodily pain and general health scores. This sub-score is reported on a scale from 0-100 with higher numbers indicating better physical functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30 Second Chair Stand</measure>
    <time_frame>baseline, 1, 3, 6 and 12 months</time_frame>
    <description>A test of leg strength and endurance. The number of times a patient stands from a sitting position in 30 seconds is recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Pain Inventory-Interference sub-score</measure>
    <time_frame>baseline, 1, 3, 6 and 12 months</time_frame>
    <description>A measure of pain and the interference of such pain on daily function. A sub-score on a scale of 0 (no interference)- 10 (maximal interference) will be recorded. The mean score of the 7 items will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Steps per day measured by accelerometer</measure>
    <time_frame>baseline, 6 months and 1 year</time_frame>
    <description>The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight Self Stigma questionnaire</measure>
    <time_frame>baseline, 1, 3, 6 and 12 months</time_frame>
    <description>A questionnaire designed to explore both internalized self stigma (internalized self-devaluation) and enacted stigma (directly experienced stigma) on function will be administered. The scale is comprised of 12 questions, and the subject responds on a scale from 1-5 with a greater score indicating greater experienced stigma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lean body mass</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Using DXA (Dual-energy X-ray Absorptiometry), lean body mass (LBM) or fat-free mass will be measured at baseline and at end of study. Percent change will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study. Percent change will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone density</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study. Percent change will be reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Obesity</condition>
  <condition>Obesity, Abdominal</condition>
  <condition>Mobility Limitation</condition>
  <condition>Quality of Life</condition>
  <condition>Back Pain</condition>
  <condition>Pain, Chronic</condition>
  <condition>Weight Change, Body</condition>
  <condition>Inactivity</condition>
  <condition>Exercise</condition>
  <condition>Body Composition</condition>
  <condition>Redundant Skin</condition>
  <arm_group>
    <arm_group_label>FeelWell™ Compression garment use with increase mobility</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are randomized to wear custom-fitted FeelWell™ Compression garment daily during regular and exercise activities.&#xD;
Subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Increase mobility</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For the control group, subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity. The control group will not be assigned a compression garment during the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FeelWell™ Compression garment</intervention_name>
    <description>Registered FDA class I device:&#xD;
The FeelWell™ Compression garment is a custom-made orthopedic abdominal binder with full or half-body support. The garments are made of 70% polyamide and 30% elastane and OEKO-TEX certified confirming human-ecological safety of textiles. The company uses a wrap knitting to ensure an optimal compression and durability. The garment has two 360 degrees whalebones in the front and two in the back to provide support for the posture, reinforcing compression on the abdomen and lower-back.</description>
    <arm_group_label>FeelWell™ Compression garment use with increase mobility</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Increase Mobility</intervention_name>
    <description>Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity</description>
    <arm_group_label>FeelWell™ Compression garment use with increase mobility</arm_group_label>
    <arm_group_label>Increase mobility</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, over 18 years old.&#xD;
&#xD;
          -  Subjects with a BMI of ≥ 35.&#xD;
&#xD;
          -  Subjects in any stage of weight loss or maintenance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to put on or have help in putting on garment.&#xD;
&#xD;
          -  Inability to participate in movement and exercise intervention.&#xD;
&#xD;
          -  Panniculus grade &gt;3 at baseline or other body habitus that limits mobility.&#xD;
&#xD;
          -  Duke Activity Status Index (DASI) score &lt; 3.62&#xD;
&#xD;
          -  Medical condition limiting participation in trial or basic mobility.&#xD;
&#xD;
          -  Current participation in a physical therapy program.&#xD;
&#xD;
          -  Unwillingness to participate fully in trial.&#xD;
&#xD;
          -  Participation in another trial at the same time.&#xD;
&#xD;
          -  Patient Health Questionnaire (PHQ)-9≥15.&#xD;
&#xD;
          -  Current or expected pregnancy&#xD;
&#xD;
          -  Investigator's discretion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Domenica Rubino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington Center for Weight Management and Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Domenica Rubino, MD</last_name>
    <phone>17038070037</phone>
    <email>mvaughan@wtmgmt.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rachel Trope, MS</last_name>
    <phone>7038070037</phone>
    <email>rtrope@wtmgmt.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Washington Center for Weight Management and Research, Inc.</name>
      <address>
        <city>Shirlington</city>
        <state>Virginia</state>
        <zip>22206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michelle Vaughan, MBA</last_name>
      <phone>703-807-0037</phone>
      <email>mvaughan@wtmgmt.com</email>
    </contact>
    <contact_backup>
      <last_name>Rachel Trope, MS</last_name>
      <phone>7038070037</phone>
      <email>rtrope@wtmgmt.com</email>
    </contact_backup>
    <investigator>
      <last_name>Domenica Rubino, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rachel Trope, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mike Reing, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.</citation>
    <PMID>12091180</PMID>
  </reference>
  <reference>
    <citation>Camarri B, Eastwood PR, Cecins NM, Thompson PJ, Jenkins S. Six minute walk distance in healthy subjects aged 55-75 years. Respir Med. 2006 Apr;100(4):658-65. doi: 10.1016/j.rmed.2005.08.003. Epub 2005 Oct 17.</citation>
    <PMID>16229997</PMID>
  </reference>
  <reference>
    <citation>Grodin JL, Hammadah M, Fan Y, Hazen SL, Tang WH. Prognostic value of estimating functional capacity with the use of the duke activity status index in stable patients with chronic heart failure. J Card Fail. 2015 Jan;21(1):44-50. doi: 10.1016/j.cardfail.2014.08.013. Epub 2014 Aug 28.</citation>
    <PMID>25175697</PMID>
  </reference>
  <reference>
    <citation>Jakicic JM, Rogers RJ, Davis KK, Collins KA. Role of Physical Activity and Exercise in Treating Patients with Overweight and Obesity. Clin Chem. 2018 Jan;64(1):99-107. doi: 10.1373/clinchem.2017.272443. Epub 2017 Nov 20.</citation>
    <PMID>29158251</PMID>
  </reference>
  <reference>
    <citation>Hebert-Losier K, Wessman C, Alricsson M, Svantesson U. Updated reliability and normative values for the standing heel-rise test in healthy adults. Physiotherapy. 2017 Dec;103(4):446-452. doi: 10.1016/j.physio.2017.03.002. Epub 2017 Mar 21.</citation>
    <PMID>28886865</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Compression garment</keyword>
  <keyword>Physical therapy</keyword>
  <keyword>Obesity</keyword>
  <keyword>Movement</keyword>
  <keyword>Abdominal binder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Abdominal</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Body Weight Changes</mesh_term>
    <mesh_term>Mobility Limitation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Once study is completed, data analyzed and published, data will be made available to any investigator who is interested upon written request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of publication.</ipd_time_frame>
    <ipd_access_criteria>Researchers must provide evidence that the data are being requested for analysis in a scientific study.</ipd_access_criteria>
  </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/NCT03798873
org study id: FeelWell2018
nct id: NCT03798873
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To assess the effect of wearing a custom-fitted, FDA-registered, Class I device, compression
      garment (Obesinov, S.A.R.L.) by an individual with a BMI ≥ 35 on his/her day-to-day quality
      of life over a period of one year. Various measures of quality of life will be taken,
      including assessing an individual's level of pain, mood, self-stigma and comfort with the use
      of a compression garment. Additionally, to assess the impact of the compression garment on
      activity, strength, posture and movement of an individual with a BMI ≥35 over the period of
      one year.
Individuals suffering with obesity often experience daily pain and discomfort which limits
      movement, a critical factor in managing weight, cardio-metabolic health, mood, sleep,
      self-esteem and ultimately overall quality of life. Many individuals who experience weight
      gain have an abdominal or central distribution of weight which affects body mechanics leading
      to back pain, poor posture, difficulty walking with altered gait, knee, foot, ankle and leg
      pain (IT band, meralgia paresthetica) and other non-specific chronic pain. Chronic pain
      impedes mobility often incorporating depression and low motivation in an endless cycle.
      Furthermore, as individuals are losing weight, they often suffer from excess skin which also
      aggravates by chafing (arms, inner thighs), hanging down and interfering with gait.

      The Investigators will examine the effect of wearing a custom-fitted, FDA-registered, Class I
      device, compression garment (Obesinov, S.A.R.L.) by participants with a BMI ≥ 35 on
      day-to-day quality of life over a period of one year. Various measures of quality of life
      will be taken, including assessing the participant's level of pain, mood, self-stigma and
      comfort with the use of a compression garment. Additional assessments include impact of the
      compression garment on activity, strength, posture and movement as well as potential impact
      of the use of this garment on weight loss and change in laboratory measures of metabolic
      health.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Test group treated with the FeelWell™ Compression garment and control group without compression garment. All subjects will receive the same intervention working with exercise physiologist and physical therapist in order to improve mobility.
primary purpose: Treatment
masking: None (Open Label)
measure: 6- minute walk test- distance walked
time frame: baseline, 1, 3, 6 and 12 months
description: 6-min walk test is a sub-maximal exercise test measuring the total distance walked by a subject in a period of 6 minutes to assess functional capacity of a subject's cardio-respiratory systems and reflects their ability to perform Activities of Daily Living. Total distance walked will be measured and change recorded from baseline.
measure: 6- minute walk test- Perceived exertion
time frame: baseline, 1, 3, 6 and 12 months
description: The Borg Rate of Perceived Exertion scale of 1-10 will be used for the subject to record their exertion level from 1 (no exertion)-10 (maximal exertion) and change will be noted from baseline.
measure: SF-36 physical component sub-score
time frame: baseline, 3, 6 and 12 months
description: SF-36 consists of 8 sub-scales of health-related quality of life measuring various aspects of functioning. The summary score for physical component includes physical functioning, physical role, bodily pain and general health scores. This sub-score is reported on a scale from 0-100 with higher numbers indicating better physical functioning.
measure: 30 Second Chair Stand
time frame: baseline, 1, 3, 6 and 12 months
description: A test of leg strength and endurance. The number of times a patient stands from a sitting position in 30 seconds is recorded.
measure: Brief Pain Inventory-Interference sub-score
time frame: baseline, 1, 3, 6 and 12 months
description: A measure of pain and the interference of such pain on daily function. A sub-score on a scale of 0 (no interference)- 10 (maximal interference) will be recorded. The mean score of the 7 items will be recorded.
measure: Steps per day measured by accelerometer
time frame: baseline, 6 months and 1 year
description: The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial.
measure: Weight Self Stigma questionnaire
time frame: baseline, 1, 3, 6 and 12 months
description: A questionnaire designed to explore both internalized self stigma (internalized self-devaluation) and enacted stigma (directly experienced stigma) on function will be administered. The scale is comprised of 12 questions, and the subject responds on a scale from 1-5 with a greater score indicating greater experienced stigma.
measure: Lean body mass
time frame: baseline, 12 months
description: Using DXA (Dual-energy X-ray Absorptiometry), lean body mass (LBM) or fat-free mass will be measured at baseline and at end of study. Percent change will be reported.
measure: Fat mass
time frame: baseline, 12 months
description: Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study. Percent change will be reported.
measure: Bone density
time frame: baseline, 12 months
description: Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study. Percent change will be reported.
arm group label: FeelWell™ Compression garment use with increase mobility
arm group type: Experimental
description: Subjects are randomized to wear custom-fitted FeelWell™ Compression garment daily during regular and exercise activities.
Subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity.
arm group label: Increase mobility
arm group type: Other
description: For the control group, subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity. The control group will not be assigned a compression garment during the trial.
intervention type: Device
intervention name: FeelWell™ Compression garment
description: Registered FDA class I device:
The FeelWell™ Compression garment is a custom-made orthopedic abdominal binder with full or half-body support. The garments are made of 70% polyamide and 30% elastane and OEKO-TEX certified confirming human-ecological safety of textiles. The company uses a wrap knitting to ensure an optimal compression and durability. The garment has two 360 degrees whalebones in the front and two in the back to provide support for the posture, reinforcing compression on the abdomen and lower-back.
arm group label: FeelWell™ Compression garment use with increase mobility
intervention type: Behavioral
intervention name: Increase Mobility
description: Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
arm group label: FeelWell™ Compression garment use with increase mobility
arm group label: Increase mobility
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Domenica Rubino, MD
role: Principal Investigator
affiliation: Washington Center for Weight Management and Research
last name: Domenica Rubino, MD
phone: 17038070037
email: mvaughan@wtmgmt.com
last name: Rachel Trope, MS
phone: 7038070037
email: rtrope@wtmgmt.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
PMID: 12091180
citation: Camarri B, Eastwood PR, Cecins NM, Thompson PJ, Jenkins S. Six minute walk distance in healthy subjects aged 55-75 years. Respir Med. 2006 Apr;100(4):658-65. doi: 10.1016/j.rmed.2005.08.003. Epub 2005 Oct 17.
PMID: 16229997
citation: Grodin JL, Hammadah M, Fan Y, Hazen SL, Tang WH. Prognostic value of estimating functional capacity with the use of the duke activity status index in stable patients with chronic heart failure. J Card Fail. 2015 Jan;21(1):44-50. doi: 10.1016/j.cardfail.2014.08.013. Epub 2014 Aug 28.
PMID: 25175697
citation: Jakicic JM, Rogers RJ, Davis KK, Collins KA. Role of Physical Activity and Exercise in Treating Patients with Overweight and Obesity. Clin Chem. 2018 Jan;64(1):99-107. doi: 10.1373/clinchem.2017.272443. Epub 2017 Nov 20.
PMID: 29158251
citation: Hebert-Losier K, Wessman C, Alricsson M, Svantesson U. Updated reliability and normative values for the standing heel-rise test in healthy adults. Physiotherapy. 2017 Dec;103(4):446-452. doi: 10.1016/j.physio.2017.03.002. Epub 2017 Mar 21.
PMID: 28886865
responsible party type: Sponsor
mesh term: Obesity
mesh term: Obesity, Abdominal
mesh term: Chronic Pain
mesh term: Body Weight Changes
mesh term: Mobility Limitation
sharing ipd: Yes
ipd description: Once study is completed, data analyzed and published, data will be made available to any investigator who is interested upon written request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available within 6 months of publication.
ipd access criteria: Researchers must provide evidence that the data are being requested for analysis in a scientific study.