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/NCT05963425</url>
    </required_header>
    <id_info>
      <org_study_id>PARKEX1</org_study_id>
      <nct_id>NCT05963425</nct_id>
    </id_info>
    <brief_title>The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients With Parkinson's Disease.</brief_title>
    <acronym>PARKEX</acronym>
    <official_title>The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients With Parkinson's Disease: a Study Protocol.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Ramon Llull</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Coimbra</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Vall d'Hebron</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Ramon Llull</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 aim of this study is to investigate the effect of physical activity on mitochondrial&#xD;
        function in skin fibroblasts in patients with Parkinson's disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized double-blind clinical trial will be conducted to study the effects of physical&#xD;
        activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease.&#xD;
        It is an intervention study, and twenty-four patients will be needed. Once the subjects have&#xD;
        been selected, they will be randomly assigned into three groups (eight patients in each&#xD;
        group). The first group will perform basic physical training (BPT) based on strength and&#xD;
        resistance, the second group will perform BPT combined with functional exercises (BPTFE) with&#xD;
        cognitive and motor training, and the third group will not carry out any activity program,&#xD;
        serving as control. The interventions will last 60 minutes, with a frequency of 3 times a&#xD;
        week, during 16 weeks. The control group will receive 4 months of PA from the program that&#xD;
        has obtained the best results,in terms of symptoms and quality of life, after the last&#xD;
        evaluation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in oxygen consumption rate</measure>
      <time_frame>Beginning of the study and after 4 months</time_frame>
      <description>Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in ATPmax levels</measure>
      <time_frame>Beginning of the study and after 4 months</time_frame>
      <description>Maximal mitochondrial ATP production rates measured by Seahorse XFe96</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Non-motor and motor function</measure>
      <time_frame>Beginning of the study, first visit</time_frame>
      <description>non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleepness</measure>
      <time_frame>Beginning of the study, first visit</time_frame>
      <description>Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mobility</measure>
      <time_frame>Beginning of the study, first visit</time_frame>
      <description>clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive aspects</measure>
      <time_frame>Beginning of the study, first visit</time_frame>
      <description>Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood</measure>
      <time_frame>Beginning of the study, first visit</time_frame>
      <description>Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-motor and motor function</measure>
      <time_frame>End of the study (4 Months)</time_frame>
      <description>non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleepness</measure>
      <time_frame>End of the study (4 Months)</time_frame>
      <description>Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mobility</measure>
      <time_frame>End of the study (4 Months)</time_frame>
      <description>clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive aspects</measure>
      <time_frame>End of the study (4 Months)</time_frame>
      <description>Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood</measure>
      <time_frame>End of the study (4 Months)</time_frame>
      <description>Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Parkinson's Disease</condition>
    <arm_group>
      <arm_group_label>Physical activity: basic physical training (BPT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exercises will target the large muscle groups, with a component/emphasis on the eccentric phase of concentration. The kBox4 Platform (Exxentric AB), a device designed to maximize performance and training outcomes, will be used to enhance the eccentric phase of the exercises.&#xD;
  kBox4 is controlled by a specific program, Kmeter, which records and stores all the information (duration, intensity, repetitions, etc.) of each movement. Exxentric kBox4 will be adapted with special harnesses, insurances on the wall and in front of support bars, according to the needs of the patients. In addition to the major muscle groups, specific attention will be given to the key muscles involved in the gait cycle, such as the tibialis anterior, medial gastrocnemius, rectus femoris, and hamstrings, from a biomechanical perspective.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Physical activity: BPT combined with functional exercises</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the BPT program (which includes the transverse focus on strength and resistance exercises), this intervention group will incorporate functional exercises that involve dual task training. The dual task training can encompass both motor-motor and motor-cognitive activities. This means that coordinated exercises will be performed, with cognitive activities introduced at the extremes of the movement. This approach ensures engagement of both physical and cognitive abilities during the PA sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in the control group will maintain their regular daily routines throughout the study period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical activity</intervention_name>
      <description>This physical activity program will be based only on the work of basic physical traininig, in which specifically and mainly the strength and resistance will be worked, but also flexibility</description>
      <arm_group_label>Physical activity: BPT combined with functional exercises</arm_group_label>
      <arm_group_label>Physical activity: basic physical training (BPT)</arm_group_label>
      <other_name>Exercise</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>usual clinical practice</intervention_name>
      <description>usual clinical practice</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with a medical diagnosis of idiopathic PD, Hoehn and Yahr scale stages of&#xD;
               I-III.&#xD;
  &#xD;
            -  Patients who score ≥26 on the Montreal Cognitive Assessment (MoCA).&#xD;
  &#xD;
            -  Patients who have signed the IC.&#xD;
  &#xD;
            -  Patients with stable medication.&#xD;
  &#xD;
            -  Age between 50 and 70 years, and able to walk independently for 6 minutes.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a pathology other than idiopathic PD.&#xD;
  &#xD;
            -  Patients with cognitive impairment (MoCA &lt;26 points).&#xD;
  &#xD;
            -  Patients with uncontrolled cardiovascular disease, visual impairment, or recent&#xD;
               musculoskeletal disorders in the extremities.&#xD;
  &#xD;
            -  Patients who are performing another therapeutic exercise protocol.&#xD;
  &#xD;
            -  Patients who have undergone surgery to influence any symptom from the PD.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joel Montane, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitat Ramon Llull</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joel Montane, PhD</last_name>
      <phone>932533256</phone>
      <email>joelmm@blanquerna.url.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Vall Hebron Institut de Recerca</name>
        <address>
          <city>Barcelona</city>
          <state>Catalonia</state>
          <zip>08031</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jorge Hernández Vara, MD</last_name>
        <phone>0034934893000</phone>
        <email>jorge.hernandez@vallhebron.cat</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Magana JC, Deus CM, Gine-Garriga M, Montane J, Pereira SP. Exercise-Boosted Mitochondrial Remodeling in Parkinson's Disease. Biomedicines. 2022 Dec 12;10(12):3228. doi: 10.3390/biomedicines10123228.</citation>
      <PMID>36551984</PMID>
    </reference>
    <reference>
      <citation>Deus CM, Pereira SP, Cunha-Oliveira T, Pereira FB, Raimundo N, Oliveira PJ. Mitochondrial remodeling in human skin fibroblasts from sporadic male Parkinson's disease patients uncovers metabolic and mitochondrial bioenergetic defects. Biochim Biophys Acta Mol Basis Dis. 2020 Mar 1;1866(3):165615. doi: 10.1016/j.bbadis.2019.165615. Epub 2019 Nov 20.</citation>
      <PMID>31759069</PMID>
    </reference>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Parkinson's Disease</keyword>
    <keyword>Physical Activity</keyword>
    <keyword>Mitochondrial Function</keyword>
    <keyword>Skin Fibroblasts</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05963425
  org study id: PARKEX1
  nct id: NCT05963425
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate the effect of physical activity on mitochondrial
        function in skin fibroblasts in patients with Parkinson's disease.
  A randomized double-blind clinical trial will be conducted to study the effects of physical
        activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease.
        It is an intervention study, and twenty-four patients will be needed. Once the subjects have
        been selected, they will be randomly assigned into three groups (eight patients in each
        group). The first group will perform basic physical training (BPT) based on strength and
        resistance, the second group will perform BPT combined with functional exercises (BPTFE) with
        cognitive and motor training, and the third group will not carry out any activity program,
        serving as control. The interventions will last 60 minutes, with a frequency of 3 times a
        week, during 16 weeks. The control group will receive 4 months of PA from the program that
        has obtained the best results,in terms of symptoms and quality of life, after the last
        evaluation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Change in oxygen consumption rate
  time frame: Beginning of the study and after 4 months
  description: Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96
  measure: Change in ATPmax levels
  time frame: Beginning of the study and after 4 months
  description: Maximal mitochondrial ATP production rates measured by Seahorse XFe96
  measure: Non-motor and motor function
  time frame: Beginning of the study, first visit
  description: non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire
  measure: Sleepness
  time frame: Beginning of the study, first visit
  description: Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire
  measure: Mobility
  time frame: Beginning of the study, first visit
  description: clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire
  measure: Cognitive aspects
  time frame: Beginning of the study, first visit
  description: Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)
  measure: Mood
  time frame: Beginning of the study, first visit
  description: Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire
  measure: Non-motor and motor function
  time frame: End of the study (4 Months)
  description: non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire
  measure: Sleepness
  time frame: End of the study (4 Months)
  description: Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire
  measure: Mobility
  time frame: End of the study (4 Months)
  description: clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire
  measure: Cognitive aspects
  time frame: End of the study (4 Months)
  description: Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)
  measure: Mood
  time frame: End of the study (4 Months)
  description: Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire
  arm group label: Physical activity: basic physical training (BPT)
  arm group type: Experimental
  description: Exercises will target the large muscle groups, with a component/emphasis on the eccentric phase of concentration. The kBox4 Platform (Exxentric AB), a device designed to maximize performance and training outcomes, will be used to enhance the eccentric phase of the exercises.
  kBox4 is controlled by a specific program, Kmeter, which records and stores all the information (duration, intensity, repetitions, etc.) of each movement. Exxentric kBox4 will be adapted with special harnesses, insurances on the wall and in front of support bars, according to the needs of the patients. In addition to the major muscle groups, specific attention will be given to the key muscles involved in the gait cycle, such as the tibialis anterior, medial gastrocnemius, rectus femoris, and hamstrings, from a biomechanical perspective.
  arm group label: Physical activity: BPT combined with functional exercises
  arm group type: Experimental
  description: In addition to the BPT program (which includes the transverse focus on strength and resistance exercises), this intervention group will incorporate functional exercises that involve dual task training. The dual task training can encompass both motor-motor and motor-cognitive activities. This means that coordinated exercises will be performed, with cognitive activities introduced at the extremes of the movement. This approach ensures engagement of both physical and cognitive abilities during the PA sessions.
  arm group label: Control
  arm group type: Active Comparator
  description: Participants in the control group will maintain their regular daily routines throughout the study period.
  intervention type: Other
  intervention name: Physical activity
  description: This physical activity program will be based only on the work of basic physical traininig, in which specifically and mainly the strength and resistance will be worked, but also flexibility
  arm group label: Physical activity: BPT combined with functional exercises
  arm group label: Physical activity: basic physical training (BPT)
  other name: Exercise
  intervention type: Other
  intervention name: usual clinical practice
  description: usual clinical practice
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Joel Montane, PhD
  role: Principal Investigator
  affiliation: Universitat Ramon Llull
  last name: Joel Montane, PhD
  phone: 932533256
  email: joelmm@blanquerna.url.edu
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  citation: Magana JC, Deus CM, Gine-Garriga M, Montane J, Pereira SP. Exercise-Boosted Mitochondrial Remodeling in Parkinson's Disease. Biomedicines. 2022 Dec 12;10(12):3228. doi: 10.3390/biomedicines10123228.
  PMID: 36551984
  citation: Deus CM, Pereira SP, Cunha-Oliveira T, Pereira FB, Raimundo N, Oliveira PJ. Mitochondrial remodeling in human skin fibroblasts from sporadic male Parkinson's disease patients uncovers metabolic and mitochondrial bioenergetic defects. Biochim Biophys Acta Mol Basis Dis. 2020 Mar 1;1866(3):165615. doi: 10.1016/j.bbadis.2019.165615. Epub 2019 Nov 20.
  PMID: 31759069
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: No