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/NCT06000124</url>
    </required_header>
    <id_info>
      <org_study_id>N202207073</org_study_id>
      <nct_id>NCT06000124</nct_id>
    </id_info>
    <brief_title>The Effect of Plyometric Training on the Balance Ability of the Lower Limbs in the Elderly</brief_title>
    <official_title>The Effect of Plyometric Training on the Balance Ability of the Lower Limbs in the Elderly</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Science and Technology Council</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Taipei Medical 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        For the elderly using plyometric training, there are very few studies on strengthening the&#xD;
        explosive power of the lower limbs of the elderly. For example, past studies have explored&#xD;
        the effect of high-speed and low-speed plyometric training on the improvement of muscle&#xD;
        contraction speed in the elderly over 60 years old. From the past researches, the study found&#xD;
        that compared with low-speed training, High-speed training can not only improve muscle&#xD;
        strength, but also effectively increase muscle speed and improve life functions. However,&#xD;
        studies using plyometric training to improve lower body balance in older adults are scarce&#xD;
        and the evidence is scant. Therefore, the purpose of this study is to explore the clinical&#xD;
        benefits of plyometric training for improving the balance ability of the lower limbs in the&#xD;
        elderly.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Plyometric training is an exercise method that has gained significant popularity in recent&#xD;
        years for effectively enhancing explosive power in the lower limbs. It involves rapid and&#xD;
        forceful muscle contractions following a quick stretch. This type of training enables the&#xD;
        body to generate maximum muscle strength for short durations during exercise. As individuals&#xD;
        age, their ability to produce explosive power decreases, particularly in the lower limbs.&#xD;
        This decline in explosive power can result in reduced responsiveness to sudden balance&#xD;
        disturbances, leading to falls among the elderly and greatly impacting their daily&#xD;
        activities. Hence, the objective of this study was to investigate the effects of a 10-week&#xD;
        plyometric training program on the balance ability of the lower limbs in elderly individuals.&#xD;
  &#xD;
        A total of 38 elderly participants, aged between 65 and 89 years, were randomly assigned to&#xD;
        either the experimental group (N=19) or the control group (N=19). The experimental group&#xD;
        underwent plyometric training three times a week, performing three rounds each session, for a&#xD;
        total intervention period of 10 weeks. The control group, on the other hand, engaged in&#xD;
        regular exercises during the same intervention period. Before and after the training program,&#xD;
        both groups underwent assessments to evaluate their balance abilities, which included the&#xD;
        30-second sit-to-stand test, time up and go test (TUG), functional reach test (FRT), and&#xD;
        lower extremity explosiveness test. To analyze the data, SPSS 18.0 statistical software was&#xD;
        used. Independent sample t-tests were employed to compare the baseline values between the two&#xD;
        groups and to determine the differences in the 30-second sit-to-stand test, TUG, FRT, and&#xD;
        force plate maximum reaction force values after the intervention. Paired samples t-tests were&#xD;
        conducted to assess changes in balance performance from pre-test to post-test. The&#xD;
        statistical significance level (α) was set at 0.05.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 14, 2023</start_date>
    <completion_date type="Actual">April 30, 2023</completion_date>
    <primary_completion_date type="Actual">April 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>
      <intervention_model_description>The experimental group underwent plyometric training three times a week, performing three rounds each session, for a total intervention period of 10 weeks. The control group, on the other hand, engaged in regular exercises during the same intervention period. Before and after the training program, both groups underwent assessments to evaluate their balance abilities, which included the 30-second sit-to-stand test, time up and go test (TUG), functional reach test (FRT), and lower extremity explosiveness test.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
      <masking_description>All subjects were randomly assigned to either the control or experimental group to receive their respective exercise programs. The outcomes assessor was blinded to the group allocation of each participant during baseline and post-intervention assessments. No group assignment information was provided to the care providers.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>30-second sit-to-stand test</measure>
      <time_frame>From enrollment to the end of treatment at 10 weeks</time_frame>
      <description>1 Instruct the patient: (1) Sit in the middle of the chair. (2) Place your hands on the opposite shoulder crossed, at the wrists. (3) Keep your feet flat on the floor. (4) Keep your back straight, and keep your arms against your chest. (5) On &quot;Go,&quot; rise to a full standing position, then sit back down again. (6) Repeat this for 30 seconds. 2 On the word &quot;Go,&quot; begin timing. If the patient must use his/her arms to stand, stop the test. Record &quot;0&quot; for the number and score. 3 Count the number of times the patient comes to a full standing position in 30 seconds. If the patient is over halfway to a standing position when 30 seconds have elapsed, count it as a stand. 4 Record the number of times the patient stands in 30 seconds.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>time up and go test (TUG)</measure>
      <time_frame>From enrollment to the end of treatment at 10 weeks</time_frame>
      <description>Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. 1 Instruct the patient:When I say &quot;Go,&quot; I want you to: (1). Stand up from the chair. (2). Walk to the line on the floor at your normal pace. (3). Turn. (4). Walk back to the chair at your normal pace. (5). Sit down again.2 On the word &quot;Go,&quot; begin timing. 3 Stop timing after patient sits back down. 4 Record time.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>functional reach test (FRT)</measure>
      <time_frame>From enrollment to the end of treatment at 10 weeks</time_frame>
      <description>Ascertaining dynamic balance.In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support. This information is correlated with risk of falling.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>lower extremity explosiveness test</measure>
      <time_frame>From enrollment to the end of treatment at 10 weeks</time_frame>
      <description>Using force plate to analysis the muscle power in lower extremities.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">38</enrollment>
    <condition>Plyometric Exercise</condition>
    <condition>Elderly</condition>
    <condition>Balance</condition>
    <arm_group>
      <arm_group_label>Plyometric exercises training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>High knee lifts, squat jumps, lunge cross jumps, squat jumping lunges, and squat jump twists are examples of plyometric exercises suitable for older adults.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Regulation exercises program</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The regulated exercise program includes the use of elastic bands, Qigong, and dance et al.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Plyometric exercises</intervention_name>
      <description>High knee lifts, squat jumps, lunge cross jumps, squat jumping lunges, and squat jump twists are examples of plyometric exercises suitable for older adults.</description>
      <arm_group_label>Plyometric exercises training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Regulation Exercises Program</intervention_name>
      <description>The regulated exercise program includes the use of elastic bands, Qigong, and dance et al.</description>
      <arm_group_label>Regulation exercises program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy elderly individuals aged 65 to 89 years, including both healthy older adults&#xD;
               and pre-frail individuals.&#xD;
  &#xD;
            2. Able to perform activities of daily living independently at home and in the community&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Severe neurological and musculoskeletal disorders of the lower limbs&#xD;
  &#xD;
            2. Severe cardiovascular disease&#xD;
  &#xD;
            3. Vestibular deficit&#xD;
  &#xD;
            4. Medication affects or improves balance ability&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chueh-Ho Lin, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Taipei Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Jiuzhuang Community Development Association</name>
        <address>
          <city>Taipei</city>
          <state>Nangang</state>
          <zip>11572</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2022</verification_date>
    <study_first_submitted>May 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All collected IPD will be shared with other researchers upon reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>starting in August 2023</ipd_time_frame>
      <ipd_access_criteria>The datasets generated in this study are available from the corresponding author upon reasonable request. PO-CHENG,CHIANG will be review requests.</ipd_access_criteria>
    </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/NCT06000124
  org study id: N202207073
  nct id: NCT06000124
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  For the elderly using plyometric training, there are very few studies on strengthening the
        explosive power of the lower limbs of the elderly. For example, past studies have explored
        the effect of high-speed and low-speed plyometric training on the improvement of muscle
        contraction speed in the elderly over 60 years old. From the past researches, the study found
        that compared with low-speed training, High-speed training can not only improve muscle
        strength, but also effectively increase muscle speed and improve life functions. However,
        studies using plyometric training to improve lower body balance in older adults are scarce
        and the evidence is scant. Therefore, the purpose of this study is to explore the clinical
        benefits of plyometric training for improving the balance ability of the lower limbs in the
        elderly.
  Plyometric training is an exercise method that has gained significant popularity in recent
        years for effectively enhancing explosive power in the lower limbs. It involves rapid and
        forceful muscle contractions following a quick stretch. This type of training enables the
        body to generate maximum muscle strength for short durations during exercise. As individuals
        age, their ability to produce explosive power decreases, particularly in the lower limbs.
        This decline in explosive power can result in reduced responsiveness to sudden balance
        disturbances, leading to falls among the elderly and greatly impacting their daily
        activities. Hence, the objective of this study was to investigate the effects of a 10-week
        plyometric training program on the balance ability of the lower limbs in elderly individuals.
  
        A total of 38 elderly participants, aged between 65 and 89 years, were randomly assigned to
        either the experimental group (N=19) or the control group (N=19). The experimental group
        underwent plyometric training three times a week, performing three rounds each session, for a
        total intervention period of 10 weeks. The control group, on the other hand, engaged in
        regular exercises during the same intervention period. Before and after the training program,
        both groups underwent assessments to evaluate their balance abilities, which included the
        30-second sit-to-stand test, time up and go test (TUG), functional reach test (FRT), and
        lower extremity explosiveness test. To analyze the data, SPSS 18.0 statistical software was
        used. Independent sample t-tests were employed to compare the baseline values between the two
        groups and to determine the differences in the 30-second sit-to-stand test, TUG, FRT, and
        force plate maximum reaction force values after the intervention. Paired samples t-tests were
        conducted to assess changes in balance performance from pre-test to post-test. The
        statistical significance level (α) was set at 0.05.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The experimental group underwent plyometric training three times a week, performing three rounds each session, for a total intervention period of 10 weeks. The control group, on the other hand, engaged in regular exercises during the same intervention period. Before and after the training program, both groups underwent assessments to evaluate their balance abilities, which included the 30-second sit-to-stand test, time up and go test (TUG), functional reach test (FRT), and lower extremity explosiveness test.
  primary purpose: Treatment
  masking: Double (Care Provider, Outcomes Assessor)
  masking description: All subjects were randomly assigned to either the control or experimental group to receive their respective exercise programs. The outcomes assessor was blinded to the group allocation of each participant during baseline and post-intervention assessments. No group assignment information was provided to the care providers.
  measure: 30-second sit-to-stand test
  time frame: From enrollment to the end of treatment at 10 weeks
  description: 1 Instruct the patient: (1) Sit in the middle of the chair. (2) Place your hands on the opposite shoulder crossed, at the wrists. (3) Keep your feet flat on the floor. (4) Keep your back straight, and keep your arms against your chest. (5) On "Go," rise to a full standing position, then sit back down again. (6) Repeat this for 30 seconds. 2 On the word "Go," begin timing. If the patient must use his/her arms to stand, stop the test. Record "0" for the number and score. 3 Count the number of times the patient comes to a full standing position in 30 seconds. If the patient is over halfway to a standing position when 30 seconds have elapsed, count it as a stand. 4 Record the number of times the patient stands in 30 seconds.
  measure: time up and go test (TUG)
  time frame: From enrollment to the end of treatment at 10 weeks
  description: Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. 1 Instruct the patient:When I say "Go," I want you to: (1). Stand up from the chair. (2). Walk to the line on the floor at your normal pace. (3). Turn. (4). Walk back to the chair at your normal pace. (5). Sit down again.2 On the word "Go," begin timing. 3 Stop timing after patient sits back down. 4 Record time.
  measure: functional reach test (FRT)
  time frame: From enrollment to the end of treatment at 10 weeks
  description: Ascertaining dynamic balance.In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support. This information is correlated with risk of falling.
  measure: lower extremity explosiveness test
  time frame: From enrollment to the end of treatment at 10 weeks
  description: Using force plate to analysis the muscle power in lower extremities.
  arm group label: Plyometric exercises training
  arm group type: Experimental
  description: High knee lifts, squat jumps, lunge cross jumps, squat jumping lunges, and squat jump twists are examples of plyometric exercises suitable for older adults.
  arm group label: Regulation exercises program
  arm group type: Active Comparator
  description: The regulated exercise program includes the use of elastic bands, Qigong, and dance et al.
  intervention type: Other
  intervention name: Plyometric exercises
  description: High knee lifts, squat jumps, lunge cross jumps, squat jumping lunges, and squat jump twists are examples of plyometric exercises suitable for older adults.
  arm group label: Plyometric exercises training
  intervention type: Other
  intervention name: Regulation Exercises Program
  description: The regulated exercise program includes the use of elastic bands, Qigong, and dance et al.
  arm group label: Regulation exercises program
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 89 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chueh-Ho Lin, PhD
  role: Principal Investigator
  affiliation: Taipei Medical University
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: All collected IPD will be shared with other researchers upon reasonable request.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: starting in August 2023
  ipd access criteria: The datasets generated in this study are available from the corresponding author upon reasonable request. PO-CHENG,CHIANG will be review requests.