<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/NCT04470362</url>
  </required_header>
  <id_info>
    <org_study_id>250982</org_study_id>
    <nct_id>NCT04470362</nct_id>
  </id_info>
  <brief_title>Effect of Proprioceptive Training on Muscle Fatigue in Older Adults</brief_title>
  <official_title>Beni-Suef University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ayman Mohamed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beni-Suef University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Summary Muscle fatigue is a serious problem commonly occur in older ages. Muscle fatigue&#xD;
      disturbs both daily life activities and rehabilitation tolerance in elderlies. Muscle fatigue&#xD;
      happens due to the motor or sensory dysfunctions. The previous interventions focused mainly&#xD;
      on the motor causes of muscle fatigue, however the important role of the sensory system in&#xD;
      driving the motor system. It has been demonstrated that proprioceptors are mainly responsible&#xD;
      for sensing the muscle fatigue. Objectives: This study will be conducted to investigate 1.&#xD;
      The effect of proprioception training on reducing the occurrence of muscle fatigue in&#xD;
      elderlies. 2. The effect of proprioceptive training on delaying the deterioration in&#xD;
      electromyographical data from muscles of lower limbs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study protocol A single blinded randomized parallel study design will be used in this study.&#xD;
      40 participants will be recruited for this study aged from 65 to 90 years old. The&#xD;
      randomization will be performed using simple envelop methods. Participants will be divided&#xD;
      into two groups, control and study groups. The control group will receive an isokinetic&#xD;
      strengthening program for the quadriceps muscles. Twenty-four strengthening session will be&#xD;
      performed using an isokinetic device. The exercise program begins with 60% of the mean peak&#xD;
      torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose&#xD;
      program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be&#xD;
      applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of&#xD;
      the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions&#xD;
      of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for&#xD;
      extensors. This program accomplished significant results in increasing the quadriceps power&#xD;
      and strength.&#xD;
&#xD;
      Participants in the study group will perform the same exercise parameters used in the control&#xD;
      group but in a different manner. The isokinetic exercise will be done with a closed eye to&#xD;
      improve the proprioception function. This exercise will be performed for 6 sets. We will add&#xD;
      another set, in which the participant will be instructed that the range of motion of the knee&#xD;
      joint will be divided into three ranges, the outer range (from 0 to 90 degrees of knee&#xD;
      flexion), the middle range (90 degrees of flexion) and inner range (from 90 degrees to 145&#xD;
      degree of flexion). During this set, the isokinetic device will be stopped at a different&#xD;
      joint angle and the participant will be asked to identify at which range the knee joint is&#xD;
      in. This modification is directed to improve the function of muscle spindles and Golgi tendon&#xD;
      organs.&#xD;
&#xD;
      Additional training will be performed by the application of three vibrators above and on both&#xD;
      sides of the knee joint to improve the function of the Pacinian and Meissner corpuscles which&#xD;
      is one of the included receptors in the sensation of the fatigue. This vibration will be set&#xD;
      at a subsensory intensity (Stochastic theory39) and a frequency fluctuating frequency from 50&#xD;
      Hz to 250 Hz to train both receptors40 and it will be performed for 20 min/each session. This&#xD;
      programs will be performed for three sessions/week for two months.&#xD;
&#xD;
      The primary outcomes measure will be the electromyographical analysis of quadriceps muscle at&#xD;
      the onset of muscle fatigue and after recovery. The secondary outcome measures will include&#xD;
      the Fatigue Index (FI) and the Rating-of-Fatigue Scale. These measurements at baseline, After&#xD;
      one month, After two months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2021</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2021</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>
  </study_design_info>
  <primary_outcome>
    <measure>EMG of quadriceps muscles</measure>
    <time_frame>Two Months</time_frame>
    <description>The electromyographical analysis of quadriceps muscle at the onset of muscle fatigue and after recovery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The fatigue index (FI)</measure>
    <time_frame>Two months</time_frame>
    <description>The fatigue index (FI) was calculated according to the following formula (Bar-Or, 1987): FI = (maximal pedal speed - minimal pedal speed) / maximal pedal speed * 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rating-of-Fatigue Scale</measure>
    <time_frame>Two months</time_frame>
    <description>he ROF scale consists of 11 numerical points that range from 0 to 10. There are also five descriptors and five diagrams to help the person understand the scale and make a rating.&#xD;
The Rating of fatigue scale consists of 11 numerical points that range from 0 to 10. There are also five descriptors and five diagrams to help the person understand the scale and make a rating.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Proprioceptive Disorders</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will receive an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing quadriceps power and strength.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the study group will perform the same exercise parameters used in the control group but in a different manner.&#xD;
The isokinetic exercise will be done with a closed eye to improve the proprioception function. This exercise will be performed for 6 sets.&#xD;
Additional training will be performed by the application of three vibrators above and on both sides of the knee joint to improve the function of the Pacinian and Meissner corpuscles which is one of the included receptors in the sensation of the fatigue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Isokinetic dynamometer</intervention_name>
    <description>an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing the quadriceps power and strength.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderlies over 65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No previous history of lower extremity trauma, serious metabolic, neurological,&#xD;
             muscular, inflammatory or cardiovascular diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beni Suef University</name>
      <address>
        <city>Banī Suwayf</city>
        <state>Bani Suwayf</state>
        <zip>43561</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Ibrahim Ragab</last_name>
      <phone>01003068518</phone>
      <email>Ibrahim.Ragab982@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ayman</last_name>
      <phone>0100306818</phone>
      <email>dr_ayman_pt@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Beni-Suef University</investigator_affiliation>
    <investigator_full_name>Ayman Mohamed</investigator_full_name>
    <investigator_title>Beni-Suef University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Somatosensory Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04470362
org study id: 250982
nct id: NCT04470362
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Summary Muscle fatigue is a serious problem commonly occur in older ages. Muscle fatigue
      disturbs both daily life activities and rehabilitation tolerance in elderlies. Muscle fatigue
      happens due to the motor or sensory dysfunctions. The previous interventions focused mainly
      on the motor causes of muscle fatigue, however the important role of the sensory system in
      driving the motor system. It has been demonstrated that proprioceptors are mainly responsible
      for sensing the muscle fatigue. Objectives: This study will be conducted to investigate 1.
      The effect of proprioception training on reducing the occurrence of muscle fatigue in
      elderlies. 2. The effect of proprioceptive training on delaying the deterioration in
      electromyographical data from muscles of lower limbs.
Study protocol A single blinded randomized parallel study design will be used in this study.
      40 participants will be recruited for this study aged from 65 to 90 years old. The
      randomization will be performed using simple envelop methods. Participants will be divided
      into two groups, control and study groups. The control group will receive an isokinetic
      strengthening program for the quadriceps muscles. Twenty-four strengthening session will be
      performed using an isokinetic device. The exercise program begins with 60% of the mean peak
      torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose
      program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be
      applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of
      the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions
      of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for
      extensors. This program accomplished significant results in increasing the quadriceps power
      and strength.

      Participants in the study group will perform the same exercise parameters used in the control
      group but in a different manner. The isokinetic exercise will be done with a closed eye to
      improve the proprioception function. This exercise will be performed for 6 sets. We will add
      another set, in which the participant will be instructed that the range of motion of the knee
      joint will be divided into three ranges, the outer range (from 0 to 90 degrees of knee
      flexion), the middle range (90 degrees of flexion) and inner range (from 90 degrees to 145
      degree of flexion). During this set, the isokinetic device will be stopped at a different
      joint angle and the participant will be asked to identify at which range the knee joint is
      in. This modification is directed to improve the function of muscle spindles and Golgi tendon
      organs.

      Additional training will be performed by the application of three vibrators above and on both
      sides of the knee joint to improve the function of the Pacinian and Meissner corpuscles which
      is one of the included receptors in the sensation of the fatigue. This vibration will be set
      at a subsensory intensity (Stochastic theory39) and a frequency fluctuating frequency from 50
      Hz to 250 Hz to train both receptors40 and it will be performed for 20 min/each session. This
      programs will be performed for three sessions/week for two months.

      The primary outcomes measure will be the electromyographical analysis of quadriceps muscle at
      the onset of muscle fatigue and after recovery. The secondary outcome measures will include
      the Fatigue Index (FI) and the Rating-of-Fatigue Scale. These measurements at baseline, After
      one month, After two months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: EMG of quadriceps muscles
time frame: Two Months
description: The electromyographical analysis of quadriceps muscle at the onset of muscle fatigue and after recovery
measure: The fatigue index (FI)
time frame: Two months
description: The fatigue index (FI) was calculated according to the following formula (Bar-Or, 1987): FI = (maximal pedal speed - minimal pedal speed) / maximal pedal speed * 100.
measure: Rating-of-Fatigue Scale
time frame: Two months
description: he ROF scale consists of 11 numerical points that range from 0 to 10. There are also five descriptors and five diagrams to help the person understand the scale and make a rating.
The Rating of fatigue scale consists of 11 numerical points that range from 0 to 10. There are also five descriptors and five diagrams to help the person understand the scale and make a rating.
arm group label: Control group
arm group type: Placebo Comparator
description: The control group will receive an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing quadriceps power and strength.
arm group label: Study group
arm group type: Experimental
description: Participants in the study group will perform the same exercise parameters used in the control group but in a different manner.
The isokinetic exercise will be done with a closed eye to improve the proprioception function. This exercise will be performed for 6 sets.
Additional training will be performed by the application of three vibrators above and on both sides of the knee joint to improve the function of the Pacinian and Meissner corpuscles which is one of the included receptors in the sensation of the fatigue.
intervention type: Device
intervention name: Isokinetic dynamometer
description: an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing the quadriceps power and strength.
arm group label: Control group
arm group label: Study group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
contact: 
contact backup: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Beni-Suef University
investigator full name: Ayman Mohamed
investigator title: Beni-Suef University
mesh term: Somatosensory Disorders
sharing ipd: Undecided