<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/NCT04423887</url>
  </required_header>
  <id_info>
    <org_study_id>FUI/CTR/2020/5</org_study_id>
    <nct_id>NCT04423887</nct_id>
  </id_info>
  <brief_title>Effects of Creatine Supplementation in Addition to Resistance Exercise Training in Patients With Knee Osteoarthritis</brief_title>
  <official_title>Effects of Creatine Supplementation in Addition to Resistance Exercise Training in Patients With Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foundation University Islamabad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Foundation University Islamabad</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>
      Despite the past decade being dedicated to bone and joint disease, the incidence and&#xD;
      prevalence rates of osteoarthritis continues to rise, and till date not curative treatment&#xD;
      has been identified for the management of knee osteoarthritis. In terms of conservative&#xD;
      management of knee osteoarthritis, pharmacological management has been the mainstay of&#xD;
      treatment, however is associated with numerous adverse effects with prolonged use, and it is&#xD;
      important to look into the non-pharmacological alternates for the management of knee&#xD;
      osteoarthritis. Research has shown resistance exercise training to be the most effective&#xD;
      non-pharmacological treatment option for the management of knee osteoarthritis, and the&#xD;
      purpose of the current study is to determine if the addition of a non-pharmacological dietry&#xD;
      supplement like creatine can amplify the beneficial effects of resistance exercise training&#xD;
      in patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">December 6, 2020</completion_date>
  <primary_completion_date type="Actual">December 6, 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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Pain: Visual Analogue Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Visual Analogue Scale was used to measure pain scoring from 0-10 cm on a horizontal 10cm line. A greater score reflects higher pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Pain: Visual Analogue Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>Visual Analogue Scale was used to measure pain scoring from 0-10 cm on a horizontal 10cm line. A greater score reflects higher pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Range of Motion</measure>
    <time_frame>2 weeks</time_frame>
    <description>Knee Range of Motion will be quantified by using Gonimeter</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>2 weeks</time_frame>
    <description>Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer</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>2 weeks</time_frame>
    <description>Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.</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, walking distance and walking speed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>5 repetition sit to stand test</measure>
    <time_frame>2 weeks</time_frame>
    <description>Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>5 repetition sit to stand test</measure>
    <time_frame>4 weeks</time_frame>
    <description>Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>2 weeks</time_frame>
    <description>Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>2 weeks</time_frame>
    <description>Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>4 weeks</time_frame>
    <description>Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall Risk</measure>
    <time_frame>2 weeks</time_frame>
    <description>Fall risk will be quantified by using Biodex balance System</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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</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>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lower Extremity Resistance Exercise Training</intervention_name>
    <description>Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM)&#xD;
3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press, leg extension, Sit to stand squat (mini squats) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)&#xD;
3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Creatine 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 Isometric isolated knee extension and knee flexion Isometric terminal knee extension Sit to stand squat Isometric knee terminal extension</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Creatine Supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrotherapy + Heating</intervention_name>
    <description>Interferential 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>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Joint Mobilization</intervention_name>
    <description>Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Creatine 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>
  </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>
  <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>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>December 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>December 7, 2020</last_update_submitted>
  <last_update_submitted_qc>December 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 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>
  <!-- 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/NCT04423887
org study id: FUI/CTR/2020/5
nct id: NCT04423887
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite the past decade being dedicated to bone and joint disease, the incidence and
      prevalence rates of osteoarthritis continues to rise, and till date not curative treatment
      has been identified for the management of knee osteoarthritis. In terms of conservative
      management of knee osteoarthritis, pharmacological management has been the mainstay of
      treatment, however is associated with numerous adverse effects with prolonged use, and it is
      important to look into the non-pharmacological alternates for the management of knee
      osteoarthritis. Research has shown resistance exercise training to be the most effective
      non-pharmacological treatment option for the management of knee osteoarthritis, and the
      purpose of the current study is to determine if the addition of a non-pharmacological dietry
      supplement like creatine can amplify the beneficial effects of resistance exercise training
      in patients with knee osteoarthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Knee Pain: Visual Analogue Scale
time frame: 2 weeks
description: Visual Analogue Scale was used to measure pain scoring from 0-10 cm on a horizontal 10cm line. A greater score reflects higher pain intensity.
measure: Knee Pain: Visual Analogue Scale
time frame: 4 weeks
description: Visual Analogue Scale was used to measure pain scoring from 0-10 cm on a horizontal 10cm line. A greater score reflects higher pain intensity.
measure: Knee Range of Motion
time frame: 2 weeks
description: Knee Range of Motion will be quantified by using Gonimeter
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: 2 weeks
description: Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
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: 2 weeks
description: Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
measure: Six Minute Walk Test
time frame: 4 weeks
description: Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
measure: 5 repetition sit to stand test
time frame: 2 weeks
description: Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
measure: 5 repetition sit to stand test
time frame: 4 weeks
description: Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: 2 weeks
description: Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: 4 weeks
description: Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%.
measure: Body Composition
time frame: 2 weeks
description: Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
measure: Body Composition
time frame: 4 weeks
description: Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
measure: Fall Risk
time frame: 2 weeks
description: Fall risk will be quantified by using Biodex balance System
measure: Fall Risk
time frame: 4 weeks
description: Fall risk 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
intervention type: Other
intervention name: Lower Extremity Resistance Exercise Training
description: Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM)
3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press, leg extension, Sit to stand squat (mini squats) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)
3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval
arm group label: Control
arm group label: Creatine 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 Isometric knee terminal extension
arm group label: Control
arm group label: Creatine Supplementation
intervention type: Device
intervention name: Electrotherapy + Heating
description: Interferential Current therapy (2P), in combination with heating pad for 20 minutes
arm group label: Control
arm group label: Creatine 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
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
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
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee