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/NCT05984498</url>
    </required_header>
    <id_info>
      <org_study_id>2022 Aug 10959 Harrison</org_study_id>
      <secondary_id>NIHR300856</secondary_id>
      <nct_id>NCT05984498</nct_id>
    </id_info>
    <brief_title>Understanding Balance Impairment in COPD</brief_title>
    <official_title>An Investigation of the Physiological and Psychosocial Mechanisms Underpinning Balance Impairment in People With Chronic Obstructive Pulmonary Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Teesside University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Teesside University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study is an observational study investigating the mechanisms of balance problems in&#xD;
        people with COPD and how COPD impacts them living their daily lives.&#xD;
  &#xD;
        The main objectives of this study are:&#xD;
  &#xD;
          -  To quantify the relationship between balance and aspects of neuromuscular function in&#xD;
             individuals with COPD, and compared to age-matched healthy controls&#xD;
  &#xD;
          -  To understand the lived experience of people with COPD and their carers&#xD;
  &#xD;
        Participants will attend an appointment at the University rehab lab to:&#xD;
  &#xD;
          -  Complete a balance test&#xD;
  &#xD;
          -  Fill out some questionnaires on mood, health status and balance and falls&#xD;
  &#xD;
          -  Complete some walking tests&#xD;
  &#xD;
          -  Have their body composition measured&#xD;
  &#xD;
          -  Have the function and strength of their leg nerves and muscles tested Researchers will&#xD;
             compare people with COPD and healthy controls (older adults without COPD or other&#xD;
             conditions known to impact balance) to see if any of the things measured are impacting&#xD;
             the balance of people with COPD more than their peers without COPD.&#xD;
  &#xD;
          -  For 10 people with COPD only they will be visited at home to observe how they carry out&#xD;
             everyday tasks and 5 of those 10 will have a follow up interview.&#xD;
  &#xD;
        Researchers will take notes and record interviews and look for similarities and interesting&#xD;
        points in the notes and transcripts of the interviews to build a picture of what living with&#xD;
        COPD is like.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic obstructive pulmonary disease (COPD) is a progressive condition that affects around&#xD;
        1.2million people in the UK. Breathlessness is the main symptom but people with COPD are also&#xD;
        more likely to fall than healthy people of the same age. Falling has emotional consequences,&#xD;
        such as feelings of shame, embarrassment and fear of falling in public which leads to&#xD;
        avoidance of outdoor activities. Researchers do not know why people with COPD fall more but&#xD;
        they have poor balance which may, in part, be due to problems with sensory and muscle&#xD;
        responses that would usually maintain balance. Symptoms of breathlessness and pain, plus&#xD;
        inactivity, may further impact balance. Physical and social environments may also have a role&#xD;
        in falls risk, but this has yet to be investigated. Pulmonary Rehabilitation (PR) which&#xD;
        includes stamina and strength exercises, alongside education and emotional support is&#xD;
        standard treatment for COPD but it does not include any balance exercises, meaning people&#xD;
        with COPD who are at a greater risk of falling do not receive any routine treatment to&#xD;
        improve balance. This study aims to investigate the physical, psychological, social and&#xD;
        environmental factors impacting on balance in people with COPD by comparing them to older&#xD;
        adults without COPD. The study will recruit from local hospital services (people with COPD&#xD;
        and their carers without COPD) and within the community (healthy older adults). Balance,&#xD;
        muscle function (size, strength and speed of nerve conduction) and physical activity will be&#xD;
        measured, and the two groups compared. Researchers will also observe patients in their own&#xD;
        homes and do follow up interviews to understand what it is like to live with COPD and the&#xD;
        challenges people face. The information from this study will be used in conjunction with&#xD;
        stakeholders to co design an intervention to improve balance in people with COPD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Balance Evaluation Systems Test (BESTest)</measure>
      <time_frame>baseline only</time_frame>
      <description>27 functional tasks scored on a 0-3 scale to give an overall percentage out from a maximum of 108 points. Higher scores indicate better balance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Activities- Specific Balance Confidence Scale (ABC)</measure>
      <time_frame>baseline only</time_frame>
      <description>A questionnaire that assesses confidence for performing 16 activities without a loss of balance. Scores for each item range between 0 (not confident) and 100% (completely confident). The total score for each item is divided by the number of items (16).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Elderly Falls Screening Test</measure>
      <time_frame>baseline only</time_frame>
      <description>A questionnaire and test that involves three questions relating to falls history in the previous 12-months and a gait speed and pattern assessment over a 5-meter course to establish falls risk. Score out of 5 with higher scores indicating a greater risk of falls.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incremental Shuttle Walk Test</measure>
      <time_frame>baseline only</time_frame>
      <description>A walking test where participants walk between two cones that are 10 meters apart to a increasingly frequent paced beep to measure exercise capacity. The diatnace walked is reported to the nearest 10m.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COPD Assessment Test</measure>
      <time_frame>baseline only</time_frame>
      <description>A questionnaire measuring COPD health related quality of life. Scored between 0 and 40 with higher scores indicating the greatest impact of COPD on quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical Research Council Dyspnoea Scale</measure>
      <time_frame>baseline only</time_frame>
      <description>A one question scale (0-4) of the impact of breathlessness with higher scores indicating greater impact of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lung function testing (spirometry) Forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FEV1/FVC)</measure>
      <time_frame>baseline only</time_frame>
      <description>A measure of lung function used to define COPD. Participants blow into a handheld spirometry device. FEV1 and FEV1 / FVC will be recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire-9 (depression)</measure>
      <time_frame>baseline only</time_frame>
      <description>A one page questionnaire that measures symptoms of depression and low mood. Scored out of 27 with higher scores indicated greater symptoms of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalised Anxiety Disorder-7 Questionnaire (anxiety)</measure>
      <time_frame>baseline only</time_frame>
      <description>A one page questionnaire that measures symptoms of anxiety. Scored out of 21 with higher scores indicating worse symptoms of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Pain Inventory</measure>
      <time_frame>baseline only</time_frame>
      <description>A two page questionnaire that records pain, pain intensity, pain location and pain interference. It consists of 9 items which are rated 0-10 with higher scores indicating a greater severity of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Somatosensory accuracy</measure>
      <time_frame>baseline only</time_frame>
      <description>Vibration sensation perception will be measured with a neurothesiometer device on both big toes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximal Voluntary Contraction Strength</measure>
      <time_frame>baseline only</time_frame>
      <description>The maximal strength that participants can generate in their thigh and calf muscles will be measured with a biodex dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Voluntary Activation Test</measure>
      <time_frame>baseline only</time_frame>
      <description>The amount of muscle available on top of a voluntary contraction in the quadriceps muscle will be measured using the biodex dynamometer and an electrical stimulus over the thigh muscles (Interpolated Twitch Technique)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hoffman's Reflex</measure>
      <time_frame>baseline only</time_frame>
      <description>The speed and size of nerve response to a stimulus that mimics balance reactions will be measured in the tibial nerve by placing a small bar over the back of the knee that gives an electrical stimulus to the nerve.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum grip strength</measure>
      <time_frame>baseline only</time_frame>
      <description>Participants hold a handheld dynamometer in their hands and squeeze the device to measure grip strength.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Monitor</measure>
      <time_frame>baseline through to 7 days</time_frame>
      <description>Participants will be asked to wear a watch sized device (Actigraph Physical Activity Monitor) on their wrists for 7 days. The actigraph device measures levels of physical activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EuroQOL-5D-5Level</measure>
      <time_frame>baseline only</time_frame>
      <description>The EQ-5D-5L descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION) and each dimension has five response levels (no problems to unable/severe problems). Responses form a 5 digit code.&#xD;
  no problems, slight problems, moderate problems, severe problems, unable to /extreme problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bioelectrical impendence analysis to record whole body composition of muscle, bone and fat</measure>
      <time_frame>baseline only</time_frame>
      <description>A bioelectrical impedance device (Tanita BIA) will record measures of body composition</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>COPD group</arm_group_label>
      <description>People with a spirometry confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Controls</arm_group_label>
      <description>Older adults over the age of 55 who do not have COPD</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          People living with COPD and people without COPD living in community settings in the North&#xD;
          East of England, UK&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          COPD&#xD;
  &#xD;
            -  Have a spirometry confirmed diagnosis of COPD as per GOLD guidelines&#xD;
  &#xD;
            -  Stable COPD (six weeks clear of exacerbation)&#xD;
  &#xD;
            -  55 years or over at the point of recruitment&#xD;
  &#xD;
            -  Able to communicate with good verbal English or use adaptive equipment to communicate&#xD;
  &#xD;
            -  Male or female Controls&#xD;
  &#xD;
            -  Free from a diagnosis of COPD (confirmed by spirometry)&#xD;
  &#xD;
            -  55 years or over at the point of recruitment&#xD;
  &#xD;
            -  Able to communicate with good verbal English or use adaptive equipment to&#xD;
  &#xD;
            -  Communicate&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          COPD&#xD;
  &#xD;
            -  Recent exacerbation of COPD (within the last six weeks)&#xD;
  &#xD;
            -  Under 55 years of age at the point of recruitment&#xD;
  &#xD;
            -  Any neurological or musculoskeletal diagnoses (e.g., strokes, Parkinson's disease or&#xD;
               chronic pain that interferes with ability to safely complete the tests&#xD;
  &#xD;
            -  Unable to provide written informed consent&#xD;
  &#xD;
            -  Unable to speak English or no translation options available&#xD;
  &#xD;
            -  Diagnosed but not corrected visual, vestibular disturbance and peripheral neuropathy&#xD;
  &#xD;
            -  Vasovagal syncope&#xD;
  &#xD;
            -  Not independent living (e.g., living in a care home or prison) Controls&#xD;
  &#xD;
            -  Abnormal lung function (FEV1 and FVC equal to or greater than 80% and FEV1/FVC equal&#xD;
               to greater than 70%)&#xD;
  &#xD;
            -  Under 55 years of age at the point of recruitment&#xD;
  &#xD;
            -  Any neurological or musculoskeletal impairment that would significantly affect balance&#xD;
               impacting ability to safely complete the assessments&#xD;
  &#xD;
            -  Unable to provide written informed consent&#xD;
  &#xD;
            -  Unable to speak English or no translation options available&#xD;
  &#xD;
            -  Any uncorrected visual or somatosensory disturbance&#xD;
  &#xD;
            -  Vasovagal syncope&#xD;
  &#xD;
            -  Living in a care home or in prison&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Samantha L Harrison, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Teesside University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kirsti J Loughran, PhD</last_name>
      <phone>01642 342934</phone>
      <email>k.loughran@tees.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Samantha L Harrison, PhD</last_name>
      <phone>01642 738412</phone>
      <email>s.l.harrison@tees.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Teesside University</name>
        <address>
          <city>Middlesbrough</city>
          <zip>TS1 3BX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kirsti J Loughran, PhD</last_name>
        <phone>07385086743</phone>
        <email>k.loughran@tees.ac.uk</email>
      </contact>
      <contact_backup>
        <last_name>Samantha L Harrison, PhD</last_name>
        <email>k.loughran@tees.ac.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Caroline Fernandes-James, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Andrew Fisher, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Teesside University</investigator_affiliation>
      <investigator_full_name>Samantha Harrison</investigator_full_name>
      <investigator_title>Professor of Respiratory Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>Chronic, Obstructive Pulmonary Disease</keyword>
    <keyword>Balance</keyword>
    <keyword>Falls</keyword>
    <keyword>Nerve Function</keyword>
    <keyword>Muscle Function</keyword>
    <keyword>Lived Experience</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05984498
  org study id: 2022 Aug 10959 Harrison
  secondary id: NIHR300856
  nct id: NCT05984498
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is an observational study investigating the mechanisms of balance problems in
        people with COPD and how COPD impacts them living their daily lives.
  
        The main objectives of this study are:
  
          -  To quantify the relationship between balance and aspects of neuromuscular function in
             individuals with COPD, and compared to age-matched healthy controls
  
          -  To understand the lived experience of people with COPD and their carers
  
        Participants will attend an appointment at the University rehab lab to:
  
          -  Complete a balance test
  
          -  Fill out some questionnaires on mood, health status and balance and falls
  
          -  Complete some walking tests
  
          -  Have their body composition measured
  
          -  Have the function and strength of their leg nerves and muscles tested Researchers will
             compare people with COPD and healthy controls (older adults without COPD or other
             conditions known to impact balance) to see if any of the things measured are impacting
             the balance of people with COPD more than their peers without COPD.
  
          -  For 10 people with COPD only they will be visited at home to observe how they carry out
             everyday tasks and 5 of those 10 will have a follow up interview.
  
        Researchers will take notes and record interviews and look for similarities and interesting
        points in the notes and transcripts of the interviews to build a picture of what living with
        COPD is like.
  Chronic obstructive pulmonary disease (COPD) is a progressive condition that affects around
        1.2million people in the UK. Breathlessness is the main symptom but people with COPD are also
        more likely to fall than healthy people of the same age. Falling has emotional consequences,
        such as feelings of shame, embarrassment and fear of falling in public which leads to
        avoidance of outdoor activities. Researchers do not know why people with COPD fall more but
        they have poor balance which may, in part, be due to problems with sensory and muscle
        responses that would usually maintain balance. Symptoms of breathlessness and pain, plus
        inactivity, may further impact balance. Physical and social environments may also have a role
        in falls risk, but this has yet to be investigated. Pulmonary Rehabilitation (PR) which
        includes stamina and strength exercises, alongside education and emotional support is
        standard treatment for COPD but it does not include any balance exercises, meaning people
        with COPD who are at a greater risk of falling do not receive any routine treatment to
        improve balance. This study aims to investigate the physical, psychological, social and
        environmental factors impacting on balance in people with COPD by comparing them to older
        adults without COPD. The study will recruit from local hospital services (people with COPD
        and their carers without COPD) and within the community (healthy older adults). Balance,
        muscle function (size, strength and speed of nerve conduction) and physical activity will be
        measured, and the two groups compared. Researchers will also observe patients in their own
        homes and do follow up interviews to understand what it is like to live with COPD and the
        challenges people face. The information from this study will be used in conjunction with
        stakeholders to co design an intervention to improve balance in people with COPD.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Balance Evaluation Systems Test (BESTest)
  time frame: baseline only
  description: 27 functional tasks scored on a 0-3 scale to give an overall percentage out from a maximum of 108 points. Higher scores indicate better balance.
  measure: The Activities- Specific Balance Confidence Scale (ABC)
  time frame: baseline only
  description: A questionnaire that assesses confidence for performing 16 activities without a loss of balance. Scores for each item range between 0 (not confident) and 100% (completely confident). The total score for each item is divided by the number of items (16).
  measure: The Elderly Falls Screening Test
  time frame: baseline only
  description: A questionnaire and test that involves three questions relating to falls history in the previous 12-months and a gait speed and pattern assessment over a 5-meter course to establish falls risk. Score out of 5 with higher scores indicating a greater risk of falls.
  measure: Incremental Shuttle Walk Test
  time frame: baseline only
  description: A walking test where participants walk between two cones that are 10 meters apart to a increasingly frequent paced beep to measure exercise capacity. The diatnace walked is reported to the nearest 10m.
  measure: COPD Assessment Test
  time frame: baseline only
  description: A questionnaire measuring COPD health related quality of life. Scored between 0 and 40 with higher scores indicating the greatest impact of COPD on quality of life.
  measure: Medical Research Council Dyspnoea Scale
  time frame: baseline only
  description: A one question scale (0-4) of the impact of breathlessness with higher scores indicating greater impact of symptoms.
  measure: Lung function testing (spirometry) Forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FEV1/FVC)
  time frame: baseline only
  description: A measure of lung function used to define COPD. Participants blow into a handheld spirometry device. FEV1 and FEV1 / FVC will be recorded.
  measure: Patient Health Questionnaire-9 (depression)
  time frame: baseline only
  description: A one page questionnaire that measures symptoms of depression and low mood. Scored out of 27 with higher scores indicated greater symptoms of depression.
  measure: Generalised Anxiety Disorder-7 Questionnaire (anxiety)
  time frame: baseline only
  description: A one page questionnaire that measures symptoms of anxiety. Scored out of 21 with higher scores indicating worse symptoms of depression.
  measure: Brief Pain Inventory
  time frame: baseline only
  description: A two page questionnaire that records pain, pain intensity, pain location and pain interference. It consists of 9 items which are rated 0-10 with higher scores indicating a greater severity of pain.
  measure: Somatosensory accuracy
  time frame: baseline only
  description: Vibration sensation perception will be measured with a neurothesiometer device on both big toes.
  measure: Maximal Voluntary Contraction Strength
  time frame: baseline only
  description: The maximal strength that participants can generate in their thigh and calf muscles will be measured with a biodex dynamometer
  measure: Voluntary Activation Test
  time frame: baseline only
  description: The amount of muscle available on top of a voluntary contraction in the quadriceps muscle will be measured using the biodex dynamometer and an electrical stimulus over the thigh muscles (Interpolated Twitch Technique)
  measure: Hoffman's Reflex
  time frame: baseline only
  description: The speed and size of nerve response to a stimulus that mimics balance reactions will be measured in the tibial nerve by placing a small bar over the back of the knee that gives an electrical stimulus to the nerve.
  measure: Maximum grip strength
  time frame: baseline only
  description: Participants hold a handheld dynamometer in their hands and squeeze the device to measure grip strength.
  measure: Physical Activity Monitor
  time frame: baseline through to 7 days
  description: Participants will be asked to wear a watch sized device (Actigraph Physical Activity Monitor) on their wrists for 7 days. The actigraph device measures levels of physical activity
  measure: EuroQOL-5D-5Level
  time frame: baseline only
  description: The EQ-5D-5L descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION) and each dimension has five response levels (no problems to unable/severe problems). Responses form a 5 digit code.
  no problems, slight problems, moderate problems, severe problems, unable to /extreme problems.
  measure: Bioelectrical impendence analysis to record whole body composition of muscle, bone and fat
  time frame: baseline only
  description: A bioelectrical impedance device (Tanita BIA) will record measures of body composition
  arm group label: COPD group
  description: People with a spirometry confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  arm group label: Healthy Controls
  description: Older adults over the age of 55 who do not have COPD
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Samantha L Harrison, PhD
  role: Study Chair
  affiliation: Teesside University
  last name: Kirsti J Loughran, PhD
  phone: 01642 342934
  email: k.loughran@tees.ac.uk
  last name: Samantha L Harrison, PhD
  phone: 01642 738412
  email: s.l.harrison@tees.ac.uk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: Teesside University
  investigator full name: Samantha Harrison
  investigator title: Professor of Respiratory Rehabilitation
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  sharing ipd: Undecided