<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/NCT03797352</url>
  </required_header>
  <id_info>
    <org_study_id>2108/11</org_study_id>
    <nct_id>NCT03797352</nct_id>
  </id_info>
  <brief_title>HOPE (Healthy Older People Everyday) To Age in Place</brief_title>
  <official_title>HOPE (Healthy Older People Everyday) To Age in Place: Design and Implementation of an Innovative and Cost Effective Electronic Rapid Geriatric Assessment Tool for the Screening and Management of Frailty in Community Dwelling Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Medical Research Council (NMRC), Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University Hospital, Singapore</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>
      Certain clinical syndromes eg frailty, sarcopenia, dementia, depression, cognitive&#xD;
      impairment, vision impairment, falls in older adults carry an increased risk for poor health&#xD;
      outcomes and if identified early, can be prevented, delayed or reversible. There is evidence&#xD;
      to suggest that exercise and dietary intervention can help delay or prevent sarcopenia,&#xD;
      frailty and dementia. Through early screening and detection of frailty and cognitive&#xD;
      impairment, the investigators will be able to identify participants at risk of future&#xD;
      physical or mental decline in primary care setting and ambulatory care clinics. Those&#xD;
      prefrail, frail but ambulant with / without cognitive impairment will be randomised to dual&#xD;
      task exercise with/without cognitive stimulation therapy and health education. The main&#xD;
      hypothesis is that the combination of multicomponent group exercise activities and dual task&#xD;
      exercise is effective in reversing frailty and improving cognition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Major challenges in the Singapore healthcare landscape include a rapidly aging population,&#xD;
      due to rising life expectancy at birth combined with declining total fertility, and an&#xD;
      epidemiological transition in the main source of disease burden from communicable and&#xD;
      infectious conditions to non-communicable, chronic conditions. While acute care will always&#xD;
      remain a crucial component of healthcare delivery systems, the increased healthcare burden&#xD;
      centered on chronic diseases and the concomitant aging population is putting increased strain&#xD;
      on healthcare resources. Frailty is reversible and progression to dementia can be delayed.&#xD;
      From most recent study, prevalence of pre-frailty is 37% and mild cognitive impairment about&#xD;
      15-20%. WHO's definition of healthy ageing is maintaining functional ability. Cognicise, a&#xD;
      dual task exercise has shown to delay decline in cognition and there are many studies which&#xD;
      shows aerobic exercise improves endurance. Patients seen in Geriatric, Medicine Clinic or&#xD;
      polyclinics who are prefrail, frail but ambulant with / without cognitive impairment will be&#xD;
      randomised to dual task exercise with/without cognitive stimulation therapy and health&#xD;
      education. In addition, high protein diet has been shown to improve muscle protein synthesis.&#xD;
      Therefore, the aims of the study are to assess: a) Assess the effectiveness of dual task&#xD;
      exercise with/without cognitive stimulation therapy b) Effect of health education alone for&#xD;
      delaying the progression to dementia and mobility decline c) Assess impact of exercise on&#xD;
      inflammatory and bone health biomarkers eg IL, TNF, Osteocalcin, sclerostin and C telopeptide&#xD;
      in a subgroup of older adults randomly selected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in frailty status</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail (3 or greater = frailty; 1 or 2 = prefrail)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional improvement</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in short physical performance battery (SPPB) summary score 3 subscales (range from 0 to 4 for balance, gait speed and chair stand) summed to give total score range from 0 to 12. The higher the value, the better the performance of lower extremity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Upper extremity strength</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in handgrip strength test performance (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of prevalence of depression</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in Geriatric Depression Scale (GDS) Scale range from 0 to 15, the higher the score, the greater the likelihood of depression. A score &gt; 5 points is suggestive of depression, a score ≥ 10 points is almost always indicative of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reduction in social isolation</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in Lubben Social Network Scale (LSNS-6). Scale range from 0 to 30, the lower the value, the more likelihood of social isolation, A score of 12 and lower delineates &quot;at-risk&quot; for social isolation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in EuroQoL-5D (EQ5D) score 5 subscales (1 to 5): Mobility, self-care, usual activities, pain/discomfort, anxiety/depressed Each subscale assessed individually.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved cognition</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in Montreal Cognitive Assessment (MoCA), the scoring range from 0 to 30, the lower the scoring, the more likelihood of cognitive impairment. A score of 26 and higher is generally considered normal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved cognition</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in Mini Mental State Examination (MMSE) score 5 subscales: Orientation (0 to 10), Registration (0 to 3), Attention and Calculation (0 to 5), Recall (0 to 3), Language and Praxis (0 to 9). Total scale range from 0 to 30, the higher the value, the less cognitive impairment. A score of 23 or lower is indicative of cognitive impairment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receive healthy ageing advice every 3 months for the duration of 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To participate in supervised Multicomponent exercise (combined exercise and cognitive activity) up to three times a week for 6 months and receive healthy ageing advice</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multicomponent exercise</intervention_name>
    <description>To identify frailty and other potential health issues, and determine if Multicomponent exercise helps at-risk elderly to have better health outcomes.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre frail or frail but ambulant (Frail scale score of at least 1)&#xD;
&#xD;
          -  Able to walk 400m aided or unaided (at least one bus stop away)&#xD;
&#xD;
          -  Has no significant heart or lung problems&#xD;
&#xD;
          -  Grip strength not more than 25kg for males and 18kg for females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to give consent personally&#xD;
&#xD;
          -  Wheelchair bound or at a very high falls risk&#xD;
&#xD;
          -  Unable to participate due to underlying health problems including severe weakness due&#xD;
             to stroke&#xD;
&#xD;
          -  Undergoing active cancer treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Associate Professor Reshma Merchant, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Hospital, Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Associate Professor Reshma Merchant, MD</last_name>
    <phone>67795555</phone>
    <email>reshmaa@nuhs.edu.sg</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 6, 2019</last_update_submitted>
  <last_update_submitted_qc>January 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University Hospital, Singapore</investigator_affiliation>
    <investigator_full_name>Medicine</investigator_full_name>
    <investigator_title>Head &amp; Senior Consultant, Division of Geriatric Medicine</investigator_title>
  </responsible_party>
  <keyword>Bone Health</keyword>
  <keyword>Cognitive Decline</keyword>
  <keyword>Health Education</keyword>
  <keyword>Mobility Decline</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03797352
org study id: 2108/11
nct id: NCT03797352
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Certain clinical syndromes eg frailty, sarcopenia, dementia, depression, cognitive
      impairment, vision impairment, falls in older adults carry an increased risk for poor health
      outcomes and if identified early, can be prevented, delayed or reversible. There is evidence
      to suggest that exercise and dietary intervention can help delay or prevent sarcopenia,
      frailty and dementia. Through early screening and detection of frailty and cognitive
      impairment, the investigators will be able to identify participants at risk of future
      physical or mental decline in primary care setting and ambulatory care clinics. Those
      prefrail, frail but ambulant with / without cognitive impairment will be randomised to dual
      task exercise with/without cognitive stimulation therapy and health education. The main
      hypothesis is that the combination of multicomponent group exercise activities and dual task
      exercise is effective in reversing frailty and improving cognition.
Major challenges in the Singapore healthcare landscape include a rapidly aging population,
      due to rising life expectancy at birth combined with declining total fertility, and an
      epidemiological transition in the main source of disease burden from communicable and
      infectious conditions to non-communicable, chronic conditions. While acute care will always
      remain a crucial component of healthcare delivery systems, the increased healthcare burden
      centered on chronic diseases and the concomitant aging population is putting increased strain
      on healthcare resources. Frailty is reversible and progression to dementia can be delayed.
      From most recent study, prevalence of pre-frailty is 37% and mild cognitive impairment about
      15-20%. WHO's definition of healthy ageing is maintaining functional ability. Cognicise, a
      dual task exercise has shown to delay decline in cognition and there are many studies which
      shows aerobic exercise improves endurance. Patients seen in Geriatric, Medicine Clinic or
      polyclinics who are prefrail, frail but ambulant with / without cognitive impairment will be
      randomised to dual task exercise with/without cognitive stimulation therapy and health
      education. In addition, high protein diet has been shown to improve muscle protein synthesis.
      Therefore, the aims of the study are to assess: a) Assess the effectiveness of dual task
      exercise with/without cognitive stimulation therapy b) Effect of health education alone for
      delaying the progression to dementia and mobility decline c) Assess impact of exercise on
      inflammatory and bone health biomarkers eg IL, TNF, Osteocalcin, sclerostin and C telopeptide
      in a subgroup of older adults randomly selected.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Changes in frailty status
time frame: 1 year
description: Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail (3 or greater = frailty; 1 or 2 = prefrail)
measure: Functional improvement
time frame: 1 year
description: Changes in short physical performance battery (SPPB) summary score 3 subscales (range from 0 to 4 for balance, gait speed and chair stand) summed to give total score range from 0 to 12. The higher the value, the better the performance of lower extremity.
measure: Upper extremity strength
time frame: 1 year
description: Changes in handgrip strength test performance (kg)
measure: Reduction of prevalence of depression
time frame: 1 year
description: Changes in Geriatric Depression Scale (GDS) Scale range from 0 to 15, the higher the score, the greater the likelihood of depression. A score > 5 points is suggestive of depression, a score ≥ 10 points is almost always indicative of depression
measure: reduction in social isolation
time frame: 1 year
description: Changes in Lubben Social Network Scale (LSNS-6). Scale range from 0 to 30, the lower the value, the more likelihood of social isolation, A score of 12 and lower delineates "at-risk" for social isolation
measure: Improved quality of life
time frame: 1 year
description: Changes in EuroQoL-5D (EQ5D) score 5 subscales (1 to 5): Mobility, self-care, usual activities, pain/discomfort, anxiety/depressed Each subscale assessed individually.
measure: Improved cognition
time frame: 1 year
description: Changes in Montreal Cognitive Assessment (MoCA), the scoring range from 0 to 30, the lower the scoring, the more likelihood of cognitive impairment. A score of 26 and higher is generally considered normal.
measure: Improved cognition
time frame: 1 year
description: Changes in Mini Mental State Examination (MMSE) score 5 subscales: Orientation (0 to 10), Registration (0 to 3), Attention and Calculation (0 to 5), Recall (0 to 3), Language and Praxis (0 to 9). Total scale range from 0 to 30, the higher the value, the less cognitive impairment. A score of 23 or lower is indicative of cognitive impairment.
arm group label: Control
arm group type: No Intervention
description: Receive healthy ageing advice every 3 months for the duration of 12 months
arm group label: Intervention
arm group type: Experimental
description: To participate in supervised Multicomponent exercise (combined exercise and cognitive activity) up to three times a week for 6 months and receive healthy ageing advice
intervention type: Other
intervention name: Multicomponent exercise
description: To identify frailty and other potential health issues, and determine if Multicomponent exercise helps at-risk elderly to have better health outcomes.
arm group label: Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Associate Professor Reshma Merchant, MD
role: Principal Investigator
affiliation: National University Hospital, Singapore
last name: Associate Professor Reshma Merchant, MD
phone: 67795555
email: reshmaa@nuhs.edu.sg
responsible party type: Principal Investigator
investigator affiliation: National University Hospital, Singapore
investigator full name: Medicine
investigator title: Head & Senior Consultant, Division of Geriatric Medicine
sharing ipd: Undecided