<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/NCT04503317</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/002724</org_study_id>
    <nct_id>NCT04503317</nct_id>
  </id_info>
  <brief_title>Effect of Phototherapy With Exercise on Coagulation in Elderly</brief_title>
  <official_title>Influence of Exercise Training Combined With Laser Phototherapy on Coagulation Profile in Senior Individuals With Obesity: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is an interventional study in which 60 obese elderly patients (30 male &amp; 30 female)&#xD;
      estimated to enroll according to random allocation and divided into two groups. The study&#xD;
      group will receive active acupuncture low level laser in addition to nasal laser irradiation&#xD;
      and aerobic exercises while the control group will aerobic exercises. The laser consists of a&#xD;
      semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch&#xD;
      comprises 10 individual laser beams for the wrist and an additional adapter for nasal&#xD;
      stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates&#xD;
      at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch&#xD;
      can be used for a variable irradiation period of 10-60 min. the device will be applied on&#xD;
      specific acupuncture points ( acupuncture point, Radial artery acupuncture points, and ulnar&#xD;
      artery acupuncture points) combined with nasal laser irradiation at the same time, once per&#xD;
      day, 3 times per week for three months&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE:&#xD;
&#xD;
      To determine whether low level laser light therapy is effective as an adjunctive therapy on&#xD;
      countering hypercoagulable state parameters (fibrinogen, bleeding time, Prothrombin time) and&#xD;
      total cholesterol (, d-dimer and c-reactive protein) as preventive strategy of venous&#xD;
      thromboembolism incidence in obese elderly patients&#xD;
&#xD;
      BACKGROUND:&#xD;
&#xD;
      In the general population the annual incidence of venous thrombosis (VT) approximates 1 in&#xD;
      1000 persons and appears to be increasing over time. Notably, incidence rates rise&#xD;
      exponentially with age with an approximate 7- to 10-fold increase from less than 55 years to&#xD;
      greater than 75 years. Aging is associated with increased levels of coagulation factors and&#xD;
      decrease in natural anticoagulant factors. This strongly supports that age-related&#xD;
      hypercoagulable state occurs in elderly.&#xD;
&#xD;
      Blood coagulation plays a critical role not only in homeostasis but also in many&#xD;
      physiological and pathological conditions. Blood coagulation potential in humans reaches a&#xD;
      young adult level around the time of weaning, followed by a gradual increase during young&#xD;
      adulthood and an almost 2-fold increase by old age.&#xD;
&#xD;
      Fibrinogen may contribute to the cardiovascular risk due to their influence on blood&#xD;
      viscosity, platelet aggregation, low-density lipoprotein deposition, blood vessel diameter&#xD;
      and cell proliferation. Most of the factors that cause venous thromboembolism are related to&#xD;
      changes in blood flow and changes in the composition of the blood.&#xD;
&#xD;
      In recent years, an innovative technology using low-level laser light has garnered an&#xD;
      exceptional level of interest across myriad medical disciplines because of its unique ability&#xD;
      to modulate cellular metabolism, therefore inducing beneficial clinical effects&#xD;
&#xD;
      Low level laser radiation has particular effect on blood viscosity by changing the sizes of&#xD;
      erythrocyte aggregates which lead to an increase in the blood flow velocity in the human&#xD;
      body. There are several reasons for the increase in the blood microcirculation under&#xD;
      irradiation. One of the major reasons is the activation of the respiratory chains of cells&#xD;
      leading to a cascade of biochemical reactions that resulting in an increase in the&#xD;
      permeability of erythrocyte membranes and an increase in the concentration of oxygen in the&#xD;
      bio tissues.&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
      countering hypercoagulable state parameters (fibrinogen, bleeding time, Prothrombin time) and&#xD;
      total cholesterol (, d-dimer and c-reactive protein) as a preventive strategy of venous&#xD;
      thromboembolism incidence in obese elderly patients&#xD;
&#xD;
      RESEARCH QUESTION:&#xD;
&#xD;
      Does low level laser therapy with aerobic exercises influence on obese elderly patients'&#xD;
      hemostatic state parameters as coagulation profile ((fibrinogen, bleeding time, Prothrombin&#xD;
      time) and total cholesterol (, d-dimer and c-reactive protein) as prevention of venous&#xD;
      thromboembolism in the obese elderly patient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Actual">May 6, 2023</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</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>fibrinogen</measure>
    <time_frame>12 weeks</time_frame>
    <description>measuring by blood analysis change of fibrinogen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prothrombin time and partial thromboplastin time</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of Prothrombin time and partial thromboplastin time by blood analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of total cholesterol by blood analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>d-dimer</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of d-dimer by blood analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>c-reactive protein</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of c-reactive protein by blood analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>body mass index</measure>
    <time_frame>12 weeks</time_frame>
    <description>measuring the participants' weights (in kilogram) and heights (in meter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-Hip ratio</measure>
    <time_frame>12 weeks</time_frame>
    <description>It is measured by dividing the participants' circumferences of their waists and hips</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hypercoagulability</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>active acupuncture low level laser and aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>active acupuncture, low level laser and aerobic exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aerobic exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>aerobic exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>active acupuncture low level laser in addition to nasal laser irradiation</intervention_name>
    <description>laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. applied on specific acupuncture points ( acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time with treadmill aerobic exercise, once per day, 3 times per week for three months</description>
    <arm_group_label>active acupuncture low level laser and aerobic exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>treadmill exercise</intervention_name>
    <description>aerobic exercise once per day, 3 times per week for three months</description>
    <arm_group_label>active acupuncture low level laser and aerobic exercise</arm_group_label>
    <arm_group_label>aerobic exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • aged from 60 to 75 y&#xD;
&#xD;
               -  • sedentary individuals&#xD;
&#xD;
               -  Body mass index 30-39.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • The exclusion criteria were as follows: smokers, diabetes, drinking alcohol,&#xD;
             presence of uncontrolled hypertension or cardiovascular diseases, weight loss program&#xD;
             participation for at least 6 months prior to the current study, medications affecting&#xD;
             blood coagulation or body weight, recent or chronic active disease, cognitive&#xD;
             impairment, presence of malignant disease, blood donation, or participation in any&#xD;
             other research during the previous 90 days of the current study Individuals suffering&#xD;
             from hepatic, renal, cardiac, chest, and endocrine diseases, as well as&#xD;
             musculoskeletal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>marwa m elsayed, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>physical therapy faculty Cairo university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physical Therapy</name>
      <address>
        <city>Cairo</city>
        <zip>11432</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>May 7, 2023</last_update_submitted>
  <last_update_submitted_qc>May 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>marwa mahmoud elsayed mahmoud</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombophilia</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>after completing the study by one year</ipd_time_frame>
    <ipd_access_criteria>journal published the study</ipd_access_criteria>
    <ipd_url>http://Scholar.cu.edu.eg/p_t</ipd_url>
  </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/NCT04503317
org study id: P.T.REC/012/002724
nct id: NCT04503317
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It is an interventional study in which 60 obese elderly patients (30 male & 30 female)
      estimated to enroll according to random allocation and divided into two groups. The study
      group will receive active acupuncture low level laser in addition to nasal laser irradiation
      and aerobic exercises while the control group will aerobic exercises. The laser consists of a
      semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch
      comprises 10 individual laser beams for the wrist and an additional adapter for nasal
      stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates
      at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch
      can be used for a variable irradiation period of 10-60 min. the device will be applied on
      specific acupuncture points ( acupuncture point, Radial artery acupuncture points, and ulnar
      artery acupuncture points) combined with nasal laser irradiation at the same time, once per
      day, 3 times per week for three months
PURPOSE:

      To determine whether low level laser light therapy is effective as an adjunctive therapy on
      countering hypercoagulable state parameters (fibrinogen, bleeding time, Prothrombin time) and
      total cholesterol (, d-dimer and c-reactive protein) as preventive strategy of venous
      thromboembolism incidence in obese elderly patients

      BACKGROUND:

      In the general population the annual incidence of venous thrombosis (VT) approximates 1 in
      1000 persons and appears to be increasing over time. Notably, incidence rates rise
      exponentially with age with an approximate 7- to 10-fold increase from less than 55 years to
      greater than 75 years. Aging is associated with increased levels of coagulation factors and
      decrease in natural anticoagulant factors. This strongly supports that age-related
      hypercoagulable state occurs in elderly.

      Blood coagulation plays a critical role not only in homeostasis but also in many
      physiological and pathological conditions. Blood coagulation potential in humans reaches a
      young adult level around the time of weaning, followed by a gradual increase during young
      adulthood and an almost 2-fold increase by old age.

      Fibrinogen may contribute to the cardiovascular risk due to their influence on blood
      viscosity, platelet aggregation, low-density lipoprotein deposition, blood vessel diameter
      and cell proliferation. Most of the factors that cause venous thromboembolism are related to
      changes in blood flow and changes in the composition of the blood.

      In recent years, an innovative technology using low-level laser light has garnered an
      exceptional level of interest across myriad medical disciplines because of its unique ability
      to modulate cellular metabolism, therefore inducing beneficial clinical effects

      Low level laser radiation has particular effect on blood viscosity by changing the sizes of
      erythrocyte aggregates which lead to an increase in the blood flow velocity in the human
      body. There are several reasons for the increase in the blood microcirculation under
      irradiation. One of the major reasons is the activation of the respiratory chains of cells
      leading to a cascade of biochemical reactions that resulting in an increase in the
      permeability of erythrocyte membranes and an increase in the concentration of oxygen in the
      bio tissues.

      HYPOTHESES:

      countering hypercoagulable state parameters (fibrinogen, bleeding time, Prothrombin time) and
      total cholesterol (, d-dimer and c-reactive protein) as a preventive strategy of venous
      thromboembolism incidence in obese elderly patients

      RESEARCH QUESTION:

      Does low level laser therapy with aerobic exercises influence on obese elderly patients'
      hemostatic state parameters as coagulation profile ((fibrinogen, bleeding time, Prothrombin
      time) and total cholesterol (, d-dimer and c-reactive protein) as prevention of venous
      thromboembolism in the obese elderly patient
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: fibrinogen
time frame: 12 weeks
description: measuring by blood analysis change of fibrinogen
measure: Prothrombin time and partial thromboplastin time
time frame: 12 weeks
description: change of Prothrombin time and partial thromboplastin time by blood analysis
measure: total cholesterol
time frame: 12 weeks
description: change of total cholesterol by blood analysis
measure: d-dimer
time frame: 12 weeks
description: change of d-dimer by blood analysis
measure: c-reactive protein
time frame: 12 weeks
description: change of c-reactive protein by blood analysis
measure: body mass index
time frame: 12 weeks
description: measuring the participants' weights (in kilogram) and heights (in meter)
measure: Waist-Hip ratio
time frame: 12 weeks
description: It is measured by dividing the participants' circumferences of their waists and hips
arm group label: active acupuncture low level laser and aerobic exercise
arm group type: Experimental
description: active acupuncture, low level laser and aerobic exercise
arm group label: aerobic exercise
arm group type: Active Comparator
description: aerobic exercise
intervention type: Device
intervention name: active acupuncture low level laser in addition to nasal laser irradiation
description: laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. applied on specific acupuncture points ( acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time with treadmill aerobic exercise, once per day, 3 times per week for three months
arm group label: active acupuncture low level laser and aerobic exercise
intervention type: Other
intervention name: treadmill exercise
description: aerobic exercise once per day, 3 times per week for three months
arm group label: active acupuncture low level laser and aerobic exercise
arm group label: aerobic exercise
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: No
last name: marwa m elsayed, phd
role: Principal Investigator
affiliation: physical therapy faculty Cairo university
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: marwa mahmoud elsayed mahmoud
investigator title: principal investigator
mesh term: Thrombophilia
mesh term: Obesity
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: after completing the study by one year
ipd access criteria: journal published the study
ipd url: http://Scholar.cu.edu.eg/p_t