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/NCT05977374</url>
    </required_header>
    <id_info>
      <org_study_id>01238</org_study_id>
      <nct_id>NCT05977374</nct_id>
    </id_info>
    <brief_title>Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.</brief_title>
    <official_title>Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Health Education Research Foundation (HERF)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Riphah International University</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>
        This research study is determined to see the effects of low-impact elliptical training on&#xD;
        knee osteoarthritis outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is designed to reduce the load of knee osteoarthritis patients in society so that&#xD;
        the individual lives a healthy life without getting caught in any form of disability. Knee&#xD;
        osteoarthritis is a progressive and degenerative disease of a joint that includes focal&#xD;
        cartilage loss, bony hypertrophy, synovial capsule thickening, and changes in structures of&#xD;
        periarticular ligaments and peripheral muscles.&#xD;
  &#xD;
        There are several techniques used to overcome the individual's pain, for instance, the&#xD;
        mobilization of the joint, prolotherapy, and the use of different electrical modalities.&#xD;
        meanwhile, an elliptical workout provides a positive result in reducing the progression of&#xD;
        overall knee joint and cartilage defects. elliptical training is included in low-impact&#xD;
        activities which are proven joint-friendly activities for the better improvement of the knee&#xD;
        joint.&#xD;
  &#xD;
        This activity works on a similar principle of cyclic compressive loading as occurs in the&#xD;
        manual mobilization of the knee joint. This activity brings out the fluid from the synovial&#xD;
        membrane on compression and upon decompression, the cartilage reabsorbs the oxygen and&#xD;
        nutrients, which crosses the synovial barrier into the synovial fluid through a double&#xD;
        diffusion system in the joint. The fluid then reaches the extra-cellular matrix that moves to&#xD;
        the multiple layers of chondrocytes for the growth of the cartilage in OA.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 12, 2022</start_date>
    <completion_date type="Actual">June 27, 2023</completion_date>
    <primary_completion_date type="Actual">May 30, 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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>one of my groups is experimental and the other one is controlled.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Knee joint pain.</measure>
      <time_frame>Baseline, 6th week and 12th week.</time_frame>
      <description>Pain is measured through KOOS questionnaire, which is the part of the KOOS and it has 9 items to identify pain scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knee joint X-rays.</measure>
      <time_frame>Baseline, 6th week and 12th week.</time_frame>
      <description>From the X-rays we will measure the medial and lateral knee joint space width through Radiant software.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knee joint stiffness and symptoms.</measure>
      <time_frame>Baseline, 6th week and 12th week.</time_frame>
      <description>This is the part of KOOS questinnaire, it involves 5 items of symptoms and 2 items of stiffnss to rule out knee joint symptoms and stiffness. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activities of daily livings impact on knee joint</measure>
      <time_frame>Baseline, 6th week and 12th week.</time_frame>
      <description>This is also the part of KOOS questionnaire, it includes 17 items to find out the scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sports activity impact on knee joint</measure>
      <time_frame>Baseline, 6th week and 12th week.</time_frame>
      <description>We can find the sports scoring through KOOS questionnaire, it embroils 5 items. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life impact on knee joint</measure>
      <time_frame>Baseline, 6th week and 12th week.</time_frame>
      <description>This one is also the part of KOOS questionnaire. it contain 4 items for scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">28</enrollment>
    <condition>Osteoarthritis, Knee</condition>
    <arm_group>
      <arm_group_label>elliptical training group.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group, Ultrasound 1MHz, 1.5W/cm2 7 mins, knee isometrics, and open chain activities. static stretching of the lower limbs will be given 10 reps each and held for 10 secs. 5 mins of warm-up activity on elliptical training will be given prior to the treatment group. then 3 mins of training with a set pace of 120 strides/min will start, then after 7 weeks, the timings will be increased to 5 mins. The base check-up will be conducted during 7 weeks and at the end of 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional treatment group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Static stretching of the lower limbs as mentioned above, Ultrasound 1MHz 1.5W/cm2 7min, knee isometrics, open chain activities, anterior-posterior Maitland knee mobilizations grade 1 and 2, and home care plan.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>experimental and conventional group</intervention_name>
      <description>Static stretchings of the lower limb, Ultrasound 1 MHz 1.5W/cm2 7 mins, knee isometrics, open chain activities, knee mobilizations grade 1 and 2, and home care plan.</description>
      <arm_group_label>Conventional treatment group</arm_group_label>
      <arm_group_label>elliptical training group.</arm_group_label>
      <other_name>Conventional group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  40- to 65-year-old.&#xD;
  &#xD;
            -  Diagnosed cases of Grade 1 and 2 Knee OA.&#xD;
  &#xD;
            -  Healthy and overweight patients will be included. (18.5- 29.5)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute musculoskeletal injury.&#xD;
  &#xD;
            -  Low back pain and Sciatica.&#xD;
  &#xD;
            -  Hip and ankle pathology.&#xD;
  &#xD;
            -  Acute infection, fever.&#xD;
  &#xD;
            -  The patient taking supplements and medications.&#xD;
  &#xD;
            -  Any knee deformity.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Islamabad Physical Therapy &amp; Rehabilitation Centre</name>
        <address>
          <city>Islamabad</city>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Riphah International University</investigator_affiliation>
      <investigator_full_name>Waqar Ahmed Awan</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Knee osteoarthritis</keyword>
    <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>
  
  
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/NCT05977374
  org study id: 01238
  nct id: NCT05977374
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This research study is determined to see the effects of low-impact elliptical training on
        knee osteoarthritis outcomes.
  This study is designed to reduce the load of knee osteoarthritis patients in society so that
        the individual lives a healthy life without getting caught in any form of disability. Knee
        osteoarthritis is a progressive and degenerative disease of a joint that includes focal
        cartilage loss, bony hypertrophy, synovial capsule thickening, and changes in structures of
        periarticular ligaments and peripheral muscles.
  
        There are several techniques used to overcome the individual's pain, for instance, the
        mobilization of the joint, prolotherapy, and the use of different electrical modalities.
        meanwhile, an elliptical workout provides a positive result in reducing the progression of
        overall knee joint and cartilage defects. elliptical training is included in low-impact
        activities which are proven joint-friendly activities for the better improvement of the knee
        joint.
  
        This activity works on a similar principle of cyclic compressive loading as occurs in the
        manual mobilization of the knee joint. This activity brings out the fluid from the synovial
        membrane on compression and upon decompression, the cartilage reabsorbs the oxygen and
        nutrients, which crosses the synovial barrier into the synovial fluid through a double
        diffusion system in the joint. The fluid then reaches the extra-cellular matrix that moves to
        the multiple layers of chondrocytes for the growth of the cartilage in OA.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: one of my groups is experimental and the other one is controlled.
  measure: Knee joint pain.
  time frame: Baseline, 6th week and 12th week.
  description: Pain is measured through KOOS questionnaire, which is the part of the KOOS and it has 9 items to identify pain scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
  measure: Knee joint X-rays.
  time frame: Baseline, 6th week and 12th week.
  description: From the X-rays we will measure the medial and lateral knee joint space width through Radiant software.
  measure: Knee joint stiffness and symptoms.
  time frame: Baseline, 6th week and 12th week.
  description: This is the part of KOOS questinnaire, it involves 5 items of symptoms and 2 items of stiffnss to rule out knee joint symptoms and stiffness. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
  measure: Activities of daily livings impact on knee joint
  time frame: Baseline, 6th week and 12th week.
  description: This is also the part of KOOS questionnaire, it includes 17 items to find out the scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
  measure: Sports activity impact on knee joint
  time frame: Baseline, 6th week and 12th week.
  description: We can find the sports scoring through KOOS questionnaire, it embroils 5 items. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
  measure: Quality of life impact on knee joint
  time frame: Baseline, 6th week and 12th week.
  description: This one is also the part of KOOS questionnaire. it contain 4 items for scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
  arm group label: elliptical training group.
  arm group type: Experimental
  description: In this group, Ultrasound 1MHz, 1.5W/cm2 7 mins, knee isometrics, and open chain activities. static stretching of the lower limbs will be given 10 reps each and held for 10 secs. 5 mins of warm-up activity on elliptical training will be given prior to the treatment group. then 3 mins of training with a set pace of 120 strides/min will start, then after 7 weeks, the timings will be increased to 5 mins. The base check-up will be conducted during 7 weeks and at the end of 12 weeks.
  arm group label: Conventional treatment group
  arm group type: Other
  description: Static stretching of the lower limbs as mentioned above, Ultrasound 1MHz 1.5W/cm2 7min, knee isometrics, open chain activities, anterior-posterior Maitland knee mobilizations grade 1 and 2, and home care plan.
  intervention type: Other
  intervention name: experimental and conventional group
  description: Static stretchings of the lower limb, Ultrasound 1 MHz 1.5W/cm2 7 mins, knee isometrics, open chain activities, knee mobilizations grade 1 and 2, and home care plan.
  arm group label: Conventional treatment group
  arm group label: elliptical training group.
  other name: Conventional group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Riphah International University
  investigator full name: Waqar Ahmed Awan
  investigator title: Professor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No