<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/NCT04423432</url>
  </required_header>
  <id_info>
    <org_study_id>FUI/CTR/2020/4</org_study_id>
    <nct_id>NCT04423432</nct_id>
  </id_info>
  <brief_title>Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis</brief_title>
  <official_title>Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foundation University Islamabad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Isra University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Foundation University Islamabad</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>
      Osteoarthritis is the 11th highest contributor to disability world wide. In terms of&#xD;
      conservative management of patients with knee osteoarthritis, Resistance exercise has been&#xD;
      shown to be an effective intervention for reducing pain and cartilage degeneration and&#xD;
      improving muscle strength, joint biomechanics and physical functioning. But, research shows&#xD;
      that co supplementation can further augment the effects of resistance exercise. However, it&#xD;
      is imperative to point out that the existing evidence is majorly focused on the individual&#xD;
      effects of resistance exercise training and non-pharmacological supplementation, and is still&#xD;
      deficient in the effects of co-supplementation in addition to resistance exercise training in&#xD;
      patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Pain: Numeric Pain Rating Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>Knee Pain will be quantified by using Numeric Pain Rating Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Range of Motion</measure>
    <time_frame>4 weeks</time_frame>
    <description>Knee Range of Motion will be quantified by using Gonimeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Isometric Muscle Strength</measure>
    <time_frame>4 weeks</time_frame>
    <description>Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six Minute Walk Test</measure>
    <time_frame>4 weeks</time_frame>
    <description>Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>4 weeks</time_frame>
    <description>Body Composition will be quantified by using Bioelectrical Impedance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall Risk</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fall risk will be quantified by using Biodex balance System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postural Stability</measure>
    <time_frame>4 weeks</time_frame>
    <description>Postural Stability will be quantified by using Biodex balance System</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Creatine Supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucoseamine/ Chondritin Sulfate Supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lower Extremity Resistance Exercise Training</intervention_name>
    <description>3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Creatine Supplementation</arm_group_label>
    <arm_group_label>Glucoseamine/ Chondritin Sulfate Supplementation</arm_group_label>
    <other_name>Lower Extremity Strength Training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Exercise Plan</intervention_name>
    <description>2 sets of 10 repetitions/day of&#xD;
AROM isolated knee extension and knee flexion&#xD;
Isometric isolated knee extension and knee flexion&#xD;
Isometric terminal knee extension&#xD;
Sit to stand squat&#xD;
terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Creatine Supplementation</arm_group_label>
    <arm_group_label>Glucoseamine/ Chondritin Sulfate Supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrotherapy + Heating</intervention_name>
    <description>Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Creatine Supplementation</arm_group_label>
    <arm_group_label>Glucoseamine/ Chondritin Sulfate Supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Joint Mobilization</intervention_name>
    <description>Tibio-femoral Anterior Glide&#xD;
Tibio-femoral Posterior Glide&#xD;
Patellofemoral Joint Mobilization</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Creatine Supplementation</arm_group_label>
    <arm_group_label>Glucoseamine/ Chondritin Sulfate Supplementation</arm_group_label>
    <other_name>Manual Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine Supplementation</intervention_name>
    <description>Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks</description>
    <arm_group_label>Creatine Supplementation</arm_group_label>
    <other_name>Creatine Monohydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glucoseamine/ Chondritin Sulfate Supplementation</intervention_name>
    <description>Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)</description>
    <arm_group_label>Glucoseamine/ Chondritin Sulfate Supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 40-70 years&#xD;
&#xD;
          -  Knee OA with history not less than three months.&#xD;
&#xD;
          -  Radiological evidences of grade III or less on Kellgren classification.&#xD;
&#xD;
          -  Knee pain on VNRS no more than 8/10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis&#xD;
&#xD;
          -  Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).&#xD;
&#xD;
          -  History of trauma or fractures in lower extremity.&#xD;
&#xD;
          -  Signs of lumbar radiculopathy or myelopathy.&#xD;
&#xD;
          -  History of knee surgery or replacement.&#xD;
&#xD;
          -  Patients on intra-articular steroid therapy within two months before the commencement&#xD;
             of the study.&#xD;
&#xD;
          -  Impaired skin sensation.&#xD;
&#xD;
          -  Impaired renal function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad Osama, PhD*</last_name>
    <role>Principal Investigator</role>
    <affiliation>Foundation University Institute of Rehabilitation Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Muhammad Osama, PhD*</last_name>
    <phone>+923325540436</phone>
    <email>osamadpt@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Foundation University Institute of Rehabilitation Sciences</name>
      <address>
        <city>Islamabad</city>
        <state>Federal</state>
        <zip>45710</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Muhammad Osama</last_name>
      <phone>03325540436</phone>
      <email>osamadpt@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Muhammad Osama, PhD*</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04423432
org study id: FUI/CTR/2020/4
nct id: NCT04423432
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Osteoarthritis is the 11th highest contributor to disability world wide. In terms of
      conservative management of patients with knee osteoarthritis, Resistance exercise has been
      shown to be an effective intervention for reducing pain and cartilage degeneration and
      improving muscle strength, joint biomechanics and physical functioning. But, research shows
      that co supplementation can further augment the effects of resistance exercise. However, it
      is imperative to point out that the existing evidence is majorly focused on the individual
      effects of resistance exercise training and non-pharmacological supplementation, and is still
      deficient in the effects of co-supplementation in addition to resistance exercise training in
      patients with knee osteoarthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Knee Pain: Numeric Pain Rating Scale
time frame: 4 weeks
description: Knee Pain will be quantified by using Numeric Pain Rating Scale
measure: Knee Range of Motion
time frame: 4 weeks
description: Knee Range of Motion will be quantified by using Gonimeter
measure: Knee Isometric Muscle Strength
time frame: 4 weeks
description: Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
measure: Six Minute Walk Test
time frame: 4 weeks
description: Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: 4 weeks
description: The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
measure: Body Composition
time frame: 4 weeks
description: Body Composition will be quantified by using Bioelectrical Impedance
measure: Fall Risk
time frame: 4 weeks
description: Fall risk will be quantified by using Biodex balance System
measure: Postural Stability
time frame: 4 weeks
description: Postural Stability will be quantified by using Biodex balance System
arm group label: Control
arm group type: Active Comparator
arm group label: Creatine Supplementation
arm group type: Experimental
arm group label: Glucoseamine/ Chondritin Sulfate Supplementation
arm group type: Experimental
intervention type: Other
intervention name: Lower Extremity Resistance Exercise Training
description: 3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)
arm group label: Control
arm group label: Creatine Supplementation
arm group label: Glucoseamine/ Chondritin Sulfate Supplementation
other name: Lower Extremity Strength Training
intervention type: Other
intervention name: Home Exercise Plan
description: 2 sets of 10 repetitions/day of
AROM isolated knee extension and knee flexion
Isometric isolated knee extension and knee flexion
Isometric terminal knee extension
Sit to stand squat
terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)
arm group label: Control
arm group label: Creatine Supplementation
arm group label: Glucoseamine/ Chondritin Sulfate Supplementation
intervention type: Device
intervention name: Electrotherapy + Heating
description: Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes
arm group label: Control
arm group label: Creatine Supplementation
arm group label: Glucoseamine/ Chondritin Sulfate Supplementation
intervention type: Procedure
intervention name: Joint Mobilization
description: Tibio-femoral Anterior Glide
Tibio-femoral Posterior Glide
Patellofemoral Joint Mobilization
arm group label: Control
arm group label: Creatine Supplementation
arm group label: Glucoseamine/ Chondritin Sulfate Supplementation
other name: Manual Therapy
intervention type: Dietary Supplement
intervention name: Creatine Supplementation
description: Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
arm group label: Creatine Supplementation
other name: Creatine Monohydrate
intervention type: Dietary Supplement
intervention name: Glucoseamine/ Chondritin Sulfate Supplementation
description: Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)
arm group label: Glucoseamine/ Chondritin Sulfate Supplementation
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Muhammad Osama, PhD*
role: Principal Investigator
affiliation: Foundation University Institute of Rehabilitation Sciences
last name: Muhammad Osama, PhD*
phone: +923325540436
email: osamadpt@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Pakistan
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No