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/NCT06029920</url>
    </required_header>
    <id_info>
      <org_study_id>IKFR.2023.08.01</org_study_id>
      <nct_id>NCT06029920</nct_id>
    </id_info>
    <brief_title>Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment</brief_title>
    <official_title>The Effect of Overground Walking on the Increase of Brain-Derived Neurotrophic Factor Levels, IL-6, HS-CRP, Cognitive Function, and Quality of Life in the Elderly</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitas Padjadjaran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitas Padjadjaran</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>
        The purpose of this research is to investigate the impact of overground walking as a part of&#xD;
        a rehabilitation program on the increase in Brain-derived neurotrophic factor (BDNF) levels,&#xD;
        decrease in IL-6 levels, decrease in hs-CRP levels, improvement in cognitive function, and&#xD;
        enhancement of quality of life (QOL) in older people with mild cognitive impairment. These&#xD;
        findings are anticipated to contribute to the efforts to elevate BDNF levels, cognitive&#xD;
        function, and QOL while reducing IL-6 and hsCRP levels in the elderly with mild cognitive&#xD;
        impairment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research employs a quasi-experimental research design using a Pretest-Posttest Design&#xD;
        approach. The Pretest-Posttest method is executed by assessing before and after the&#xD;
        intervention within the same group.&#xD;
  &#xD;
        All research subjects receive the same treatment, which involves participating in an&#xD;
        overground walking program on a flat surface. The selected research subjects are provided&#xD;
        with an explanation of the research's objectives and benefits and the exercise and&#xD;
        examination procedures, then sign the informed consent.&#xD;
  &#xD;
        Research subjects are instructed to walk on a flat surface for a distance of 15 meters, with&#xD;
        a duration of 20 minutes, increasing by 5 minutes each week until the target heart rate is&#xD;
        achieved during the exercise. After an 8-week post-intervention period, research subjects&#xD;
        will undergo a follow-up examination.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <phase>N/A</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>BDNF</measure>
      <time_frame>8 weeks</time_frame>
      <description>Brain-derived neurotrophic factor level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IL6</measure>
      <time_frame>8 weeks</time_frame>
      <description>Interleukin-6 level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>hsCRP</measure>
      <time_frame>8 weeks</time_frame>
      <description>hs-CRP level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MoCAINA</measure>
      <time_frame>8 weeks</time_frame>
      <description>MONTREAL COGNITIVE ASSESSMENT INDONESIA</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ADQOL</measure>
      <time_frame>8 weeks</time_frame>
      <description>Alzheimer disease Quality of Life</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Cognitive Impairment</condition>
    <condition>Aging</condition>
    <arm_group>
      <arm_group_label>Subjects</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Overground Walking</intervention_name>
      <description>Walk on a flat surface for a distance of 15 meters, with a duration of 20 minutes, increasing by 5 minutes each week until the target heart rate is achieved during the exercise, for 8 weeks.</description>
      <arm_group_label>Subjects</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Mild cognitive impairment (MoCA INA Score 19-25 out of 30&#xD;
  &#xD;
            -  Barthel Index Score 20&#xD;
  &#xD;
            -  Geriatric Depression Scale Score ≤ 5&#xD;
  &#xD;
            -  Timed Up and Go Test &lt; 15 seconds)&#xD;
  &#xD;
            -  Capable of comprehending verbal and written instructions&#xD;
  &#xD;
            -  Capable of walking unassisted&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The presence of hearing impairment that could hinder the subject from receiving verbal&#xD;
               instructions,&#xD;
  &#xD;
            -  The presence of uncorrected visual impairment&#xD;
  &#xD;
            -  Having musculoskeletal disorders&#xD;
  &#xD;
            -  Receiving other rehabilitation programs,&#xD;
  &#xD;
            -  Presence of diseases causing cognitive impairment&#xD;
  &#xD;
            -  Severe joint diseases such as osteoarthritis and rheumatoid arthritis that may worsen&#xD;
               during exercise or could pose difficulties in carrying out the exercise program,&#xD;
  &#xD;
            -  Severe cardiovascular diseases as diagnosed by a Cardiologist&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Irma Ruslina Defi</last_name>
      <phone>081316908139</phone>
      <email>Irma.ruslina@unpad.ac.id</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nursing Home</name>
        <address>
          <city>Bandung</city>
          <state>Jawa Barat</state>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sunarti</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <reference>
      <citation>Amieva H, Letenneur L, Dartigues JF, Rouch-Leroyer I, Sourgen C, D'Alchee-Biree F, Dib M, Barberger-Gateau P, Orgogozo JM, Fabrigoule C. Annual rate and predictors of conversion to dementia in subjects presenting mild cognitive impairment criteria defined according to a population-based study. Dement Geriatr Cogn Disord. 2004;18(1):87-93. doi: 10.1159/000077815. Epub 2004 Apr 14.</citation>
      <PMID>15087583</PMID>
    </reference>
    <reference>
      <citation>Barrios H, Narciso S, Guerreiro M, Maroco J, Logsdon R, de Mendonca A. Quality of life in patients with mild cognitive impairment. Aging Ment Health. 2013;17(3):287-92. doi: 10.1080/13607863.2012.747083. Epub 2012 Dec 7.</citation>
      <PMID>23215827</PMID>
    </reference>
    <reference>
      <citation>Bavelier D, Neville HJ. Cross-modal plasticity: where and how? Nat Rev Neurosci. 2002 Jun;3(6):443-52. doi: 10.1038/nrn848.</citation>
      <PMID>12042879</PMID>
    </reference>
    <reference>
      <citation>Burkhalter TM, Hillman CH. A narrative review of physical activity, nutrition, and obesity to cognition and scholastic performance across the human lifespan. Adv Nutr. 2011 Mar;2(2):201S-6S. doi: 10.3945/an.111.000331. Epub 2011 Mar 10.</citation>
      <PMID>22332052</PMID>
    </reference>
    <reference>
      <citation>Chieffi S, Messina G, Villano I, Messina A, Valenzano A, Moscatelli F, Salerno M, Sullo A, Avola R, Monda V, Cibelli G, Monda M. Neuroprotective Effects of Physical Activity: Evidence from Human and Animal Studies. Front Neurol. 2017 May 22;8:188. doi: 10.3389/fneur.2017.00188. eCollection 2017.</citation>
      <PMID>28588546</PMID>
    </reference>
    <reference>
      <citation>Dik M, Deeg DJ, Visser M, Jonker C. Early life physical activity and cognition at old age. J Clin Exp Neuropsychol. 2003 Aug;25(5):643-53. doi: 10.1076/jcen.25.5.643.14583.</citation>
      <PMID>12815502</PMID>
    </reference>
    <reference>
      <citation>Espino DV, Lichtenstein MJ, Palmer RF, Hazuda HP. Ethnic differences in mini-mental state examination (MMSE) scores: where you live makes a difference. J Am Geriatr Soc. 2001 May;49(5):538-48. doi: 10.1046/j.1532-5415.2001.49111.x.</citation>
      <PMID>11380745</PMID>
    </reference>
    <reference>
      <citation>Harada CN, Natelson Love MC, Triebel KL. Normal cognitive aging. Clin Geriatr Med. 2013 Nov;29(4):737-52. doi: 10.1016/j.cger.2013.07.002.</citation>
      <PMID>24094294</PMID>
    </reference>
    <reference>
      <citation>Shams A, Nobari H, Afonso J, Abbasi H, Mainer-Pardos E, Perez-Gomez J, Bayati M, Bahrami A, Carneiro L. Effect of Aerobic-Based Exercise on Psychological Well-Being and Quality of Life Among Older People: A Middle East Study. Front Public Health. 2021 Dec 6;9:764044. doi: 10.3389/fpubh.2021.764044. eCollection 2021.</citation>
      <PMID>34938705</PMID>
    </reference>
    <reference>
      <citation>Xue J, Li J, Liang J, Chen S. The Prevalence of Mild Cognitive Impairment in China: A Systematic Review. Aging Dis. 2018 Aug 1;9(4):706-715. doi: 10.14336/AD.2017.0928. eCollection 2018 Aug.</citation>
      <PMID>30090658</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitas Padjadjaran</investigator_affiliation>
      <investigator_full_name>Irma Ruslina Defi</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Exercise</keyword>
    <keyword>Rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <!-- 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/NCT06029920
  org study id: IKFR.2023.08.01
  nct id: NCT06029920
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research is to investigate the impact of overground walking as a part of
        a rehabilitation program on the increase in Brain-derived neurotrophic factor (BDNF) levels,
        decrease in IL-6 levels, decrease in hs-CRP levels, improvement in cognitive function, and
        enhancement of quality of life (QOL) in older people with mild cognitive impairment. These
        findings are anticipated to contribute to the efforts to elevate BDNF levels, cognitive
        function, and QOL while reducing IL-6 and hsCRP levels in the elderly with mild cognitive
        impairment.
  This research employs a quasi-experimental research design using a Pretest-Posttest Design
        approach. The Pretest-Posttest method is executed by assessing before and after the
        intervention within the same group.
  
        All research subjects receive the same treatment, which involves participating in an
        overground walking program on a flat surface. The selected research subjects are provided
        with an explanation of the research's objectives and benefits and the exercise and
        examination procedures, then sign the informed consent.
  
        Research subjects are instructed to walk on a flat surface for a distance of 15 meters, with
        a duration of 20 minutes, increasing by 5 minutes each week until the target heart rate is
        achieved during the exercise. After an 8-week post-intervention period, research subjects
        will undergo a follow-up examination.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: BDNF
  time frame: 8 weeks
  description: Brain-derived neurotrophic factor level
  measure: IL6
  time frame: 8 weeks
  description: Interleukin-6 level
  measure: hsCRP
  time frame: 8 weeks
  description: hs-CRP level
  measure: MoCAINA
  time frame: 8 weeks
  description: MONTREAL COGNITIVE ASSESSMENT INDONESIA
  measure: ADQOL
  time frame: 8 weeks
  description: Alzheimer disease Quality of Life
  arm group label: Subjects
  arm group type: Experimental
  intervention type: Other
  intervention name: Overground Walking
  description: Walk on a flat surface for a distance of 15 meters, with a duration of 20 minutes, increasing by 5 minutes each week until the target heart rate is achieved during the exercise, for 8 weeks.
  arm group label: Subjects
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Irma Ruslina Defi
  phone: 081316908139
  email: Irma.ruslina@unpad.ac.id
  facility: 
  status: Recruiting
  contact: 
  country: Indonesia
  citation: Amieva H, Letenneur L, Dartigues JF, Rouch-Leroyer I, Sourgen C, D'Alchee-Biree F, Dib M, Barberger-Gateau P, Orgogozo JM, Fabrigoule C. Annual rate and predictors of conversion to dementia in subjects presenting mild cognitive impairment criteria defined according to a population-based study. Dement Geriatr Cogn Disord. 2004;18(1):87-93. doi: 10.1159/000077815. Epub 2004 Apr 14.
  PMID: 15087583
  citation: Barrios H, Narciso S, Guerreiro M, Maroco J, Logsdon R, de Mendonca A. Quality of life in patients with mild cognitive impairment. Aging Ment Health. 2013;17(3):287-92. doi: 10.1080/13607863.2012.747083. Epub 2012 Dec 7.
  PMID: 23215827
  citation: Bavelier D, Neville HJ. Cross-modal plasticity: where and how? Nat Rev Neurosci. 2002 Jun;3(6):443-52. doi: 10.1038/nrn848.
  PMID: 12042879
  citation: Burkhalter TM, Hillman CH. A narrative review of physical activity, nutrition, and obesity to cognition and scholastic performance across the human lifespan. Adv Nutr. 2011 Mar;2(2):201S-6S. doi: 10.3945/an.111.000331. Epub 2011 Mar 10.
  PMID: 22332052
  citation: Chieffi S, Messina G, Villano I, Messina A, Valenzano A, Moscatelli F, Salerno M, Sullo A, Avola R, Monda V, Cibelli G, Monda M. Neuroprotective Effects of Physical Activity: Evidence from Human and Animal Studies. Front Neurol. 2017 May 22;8:188. doi: 10.3389/fneur.2017.00188. eCollection 2017.
  PMID: 28588546
  citation: Dik M, Deeg DJ, Visser M, Jonker C. Early life physical activity and cognition at old age. J Clin Exp Neuropsychol. 2003 Aug;25(5):643-53. doi: 10.1076/jcen.25.5.643.14583.
  PMID: 12815502
  citation: Espino DV, Lichtenstein MJ, Palmer RF, Hazuda HP. Ethnic differences in mini-mental state examination (MMSE) scores: where you live makes a difference. J Am Geriatr Soc. 2001 May;49(5):538-48. doi: 10.1046/j.1532-5415.2001.49111.x.
  PMID: 11380745
  citation: Harada CN, Natelson Love MC, Triebel KL. Normal cognitive aging. Clin Geriatr Med. 2013 Nov;29(4):737-52. doi: 10.1016/j.cger.2013.07.002.
  PMID: 24094294
  citation: Shams A, Nobari H, Afonso J, Abbasi H, Mainer-Pardos E, Perez-Gomez J, Bayati M, Bahrami A, Carneiro L. Effect of Aerobic-Based Exercise on Psychological Well-Being and Quality of Life Among Older People: A Middle East Study. Front Public Health. 2021 Dec 6;9:764044. doi: 10.3389/fpubh.2021.764044. eCollection 2021.
  PMID: 34938705
  citation: Xue J, Li J, Liang J, Chen S. The Prevalence of Mild Cognitive Impairment in China: A Systematic Review. Aging Dis. 2018 Aug 1;9(4):706-715. doi: 10.14336/AD.2017.0928. eCollection 2018 Aug.
  PMID: 30090658
  responsible party type: Principal Investigator
  investigator affiliation: Universitas Padjadjaran
  investigator full name: Irma Ruslina Defi
  investigator title: Principal Investigator
  mesh term: Cognitive Dysfunction