<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/NCT03289091</url>
  </required_header>
  <id_info>
    <org_study_id>WATER</org_study_id>
    <nct_id>NCT03289091</nct_id>
  </id_info>
  <brief_title>Effects of Two Water-based Aerobic Training Programs in Elderly Women</brief_title>
  <official_title>Effects of Two Water-based Aerobic Training Programs on Cardiorespiratory and Neuromuscular Parameters in Elderly Women: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Pelotas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Pelotas</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>
      The aim of the study is to investigate the effects of two water based aerobic training&#xD;
      programs on cardiorespiratory, neuromuscular and quality of life parameters in old women.&#xD;
&#xD;
      Volunteer old women age range: 60-75 years old, will participate to this study, and will&#xD;
      randomly divided into two groups: continuous aerobic training group and interval aerobic&#xD;
      training group.&#xD;
&#xD;
      Both group subjects will participate in two-week training sessions during 12 weeks.&#xD;
      Independent of the group, participants will perform three water-based exercises: stationary&#xD;
      running, frontal kick and cross-country skiing. The intensity of aerobic exercise will be&#xD;
      based Rating Perceived Exertion (RPE). Along the training, the intensity of aerobic exercise&#xD;
      will increase in both groups. Before and after intervention, there will be evaluation of&#xD;
      muscle quality, muscle thickness, peak oxygen uptake and oxygen uptake at ventilatory&#xD;
      threshold, maximal isometric and dynamic strength of knee extensors, maximal and submaximal&#xD;
      isometric eletromiografy (EMG) activity of vastus lateralis and rectus femoris, muscle&#xD;
      endurance, performance in functional tests and assessment of the perception of quality of&#xD;
      life.&#xD;
&#xD;
      Data will be analyzed by Generalized Estimating Equations (GEE) and Bonferroni's post-hoc&#xD;
      test (α=0.05), including both protocol and intention to treat analyses (α=0,05).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aging is associated with impairment in cardiorespiratory fitness, strength performance and&#xD;
      muscle mass decrease, which affects the functional capacity of older adults directly.&#xD;
      Consequently carrying out routine activities can be harmed. However regular exercise practice&#xD;
      points out as an efficient tool to mitigate factors associated with aging.&#xD;
&#xD;
      Therefore, carrying out water-based exercises has been widely suggested for older adults due&#xD;
      to their advantages, such as low impact on lower limbs and lower cardiovascular load.&#xD;
&#xD;
      The aim of the study is to investigate the effects of two water based aerobic training&#xD;
      programs on cardiorespiratory, neuromuscular and quality of life parameters in old women.&#xD;
&#xD;
      Volunteer old women age range: 60-75 years old, will participate to this study, and will&#xD;
      randomly divided into two groups: continuous aerobic training group and interval aerobic&#xD;
      training group.&#xD;
&#xD;
      Both group subjects will participate in two-week training sessions during 12 weeks.&#xD;
      Independent of the group, participants will perform three water-based exercises: stationary&#xD;
      running, frontal kick and cross-country skiing. The intensity of aerobic exerecise will be&#xD;
      based Rating Perceived Exertion (RPE). Along the training, the intensity of aerobic exercise&#xD;
      will increase.&#xD;
&#xD;
      Participants who will be randomized for the continuous aerobic training group will carry out&#xD;
      exercises with no interval for exercise change. Intensity will be increased every mesocycle.&#xD;
      In the first mesocycle (weeks 1-4), participants will carry out three 4-minute series of each&#xD;
      exercise whose intensity corresponds to the Rating of Perceived Exertion (RPE) 13. In the&#xD;
      second mesocycle (weeks 5-8), participants will perform four 3-minute series of each exercise&#xD;
      corresponding to RPE 14. In the third mesocycle, participants will perform six 2-minute&#xD;
      series of each exercise at intensity corresponding to RPE 15 from weeks 9-10, whereas&#xD;
      intensity corresponding to RPE 16 will be experienced from weeks 11-12.&#xD;
&#xD;
      Participants who will be randomized for interval aerobic training group will carry out&#xD;
      exercises which associate effort phases, at higher intensity and recovery phases, at lower&#xD;
      intensity, with no interval for exercise change. Intensity will be increased every mesocycle.&#xD;
      The first mesocycle (weeks 1-4) comprises three 4-minute series of each exercise whose&#xD;
      intensity corresponds to the RPE 16 for 2 minutes and RPE 11 for 2 minutes. The second&#xD;
      mesocycle (weeks 5-8) includes four 3-minute series of each exercise whose intensity&#xD;
      corresponds to the RPE 17 for 1.5 minutes and RPE 11 for 2 minutes. The third mesocycle&#xD;
      (weeks 9-12) comprises six 2-minute series of each exercise whose intensity corresponds to&#xD;
      the RPE 18 for 1 minute and RPE 11 for 1 minute.&#xD;
&#xD;
      Before and after intervention, there will be evaluation of muscle quality, muscle thickness,&#xD;
      peak oxygen uptake and oxygen uptake at ventilatory threshold, maximal isometric and dynamic&#xD;
      strength of knee extensors, maximal and submaximal isometric eletromiografy (EMG) activity of&#xD;
      vastus lateralis and rectus femoris, muscle endurance, performance in functional tests and&#xD;
      assessment of the perception of quality of life.&#xD;
&#xD;
      Data will be analyzed by Generalized Estimating Equations (GEE) and Bonferroni's post-hoc&#xD;
      test (α=0.05), including both protocol and intention to treat analyses (α=0,05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiorespiratory Fitness evaluation change after 12 weeks</measure>
    <time_frame>Testing of VO2peak change - Baseline and 12 week</time_frame>
    <description>We created a protocol on the treadmill to determine the peak oxygen uptake change(VO2peak), the first ventilatory threshold and the second ventilatory threshold. The protocol consists in 1-minute stages. The initial speed is 1.86 miles per hour. In each stage, the speed increases 0.3 miles per hour and every 2 stages, the treadmill inclination increases 1%. The test is interrupted when the subject indicates exhaustion. The respiratory gases will be collected through a portable gas analyzer (VO2000, MedGraphics, Ann Arbor, USA).&#xD;
The maximum value of VO2 , closed to exhaustion will be considered the VO2peak. The fist and the second ventilatory threshold will be determined by the ventilation versus intensity curve and confirmed by the O2 and Carbon dioxide ventilatory equivalents by two independent physiologists in a visual inspection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life change after 12 weeks (Score)</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>World Health Organization Quality of Life-bref - WHOQOL-bref</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal dynamic strength change after 12 weeks (kg)</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>maximum repetition of knee extensors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal voluntary isometric contraction of knee extensors change after 12 weeks</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>electromyography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle thickness of knee extensors change after 12 weeks</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>ultrasound image</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuromuscular economy of vastus lateralis and rectus femoris change after 12 weeks</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>electromyography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximum muscular activity of vastus lateralis and rectus femoris change after 12 weeks</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>electromyography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Elderly Women</condition>
  <arm_group>
    <arm_group_label>water-based continuous aerobic training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who will be randomized for the intervention in the continuous aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-4), participants will carry out three 4-minute series of each exercise whose intensity corresponds to the Rating of Perceived Exertion (RPE) 13. In the second mesocycle (weeks 5-8), participants will perform four 3-minute series of each exercise corresponding to RPE 14. In the third mesocycle, participants will perform six 2-minute series of each exercise at intensity corresponding to RPE 15 from weeks 9-10, whereas intensity corresponding to RPE 16 will be experienced from weeks 11-12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>water-based interval aerobic training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who will be randomized for the intervention in the interval aerobic training group will carry out exercises which associate effort phases, at higher intensity and recovery phases, at lower intensity, with no interval for exercise change. Intensity will be increased every mesocycle. The first mesocycle (weeks 1-4) comprises three 4-minute series of each exercise whose intensity corresponds to the RPE 16 for 2 minutes and RPE 11 for 2 minutes. The second mesocycle (weeks 5-8) includes four 3-minute series of each exercise whose intensity corresponds to the RPE 17 for 1.5 minutes and RPE 11 for 2 minutes. The third mesocycle (weeks 9-12) comprises six 2-minute series of each exercise whose intensity corresponds to the RPE 18 for 1 minute and RPE 11 for 1 minute.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>water-based continuous aerobic training</intervention_name>
    <description>Participants who will be randomized for the continuous aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-4), participants will carry out three 4-minute series of each exercise whose intensity corresponds to the Rating of Perceived Exertion (RPE) 13. In the second mesocycle (weeks 5-8), participants will perform four 3-minute series of each exercise corresponding to RPE 14. In the third mesocycle, participants will perform six 2-minute series of each exercise at intensity corresponding to RPE 15 from weeks 9-10, whereas intensity corresponding to RPE 16 will be experienced from weeks 11-12.</description>
    <arm_group_label>water-based continuous aerobic training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>water-based interval aerobic training</intervention_name>
    <description>Participants who will be randomized for interval aerobic training group will carry out exercises which associate effort phases, at higher intensity and recovery phases, at lower intensity, with no interval for exercise change. Intensity will be increased every mesocycle. The first mesocycle (weeks 1-4) comprises three 4-minute series of each exercise whose intensity corresponds to the RPE 16 for 2 minutes and RPE 11 for 2 minutes. The second mesocycle (weeks 5-8) includes four 3-minute series of each exercise whose intensity corresponds to the RPE 17 for 1.5 minutes and RPE 11 for 2 minutes. The third mesocycle (weeks 9-12) comprises six 2-minute series of each exercise whose intensity corresponds to the RPE 18 for 1 minute and RPE 11 for 1 minute.</description>
    <arm_group_label>water-based interval aerobic training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Volunteer elderly women, aged between 60-75 years old who were not participating on any&#xD;
        regular training program in the last six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular disease (except hypertension controlled by medication);&#xD;
&#xD;
          -  Physical impairments for exercise diagnosed through anamnesis;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristine Alberton, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>UFPel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de Pelotas</name>
      <address>
        <city>Pelotas</city>
        <state>RS</state>
        <zip>96055-630</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Pelotas</investigator_affiliation>
    <investigator_full_name>Stephanie Santana Pinto</investigator_full_name>
    <investigator_title>Professor in Physical Education School</investigator_title>
  </responsible_party>
  <keyword>aerobic training</keyword>
  <keyword>aquatic exercise</keyword>
  <keyword>aging</keyword>
  <!-- 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/NCT03289091
org study id: WATER
nct id: NCT03289091
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the effects of two water based aerobic training
      programs on cardiorespiratory, neuromuscular and quality of life parameters in old women.

      Volunteer old women age range: 60-75 years old, will participate to this study, and will
      randomly divided into two groups: continuous aerobic training group and interval aerobic
      training group.

      Both group subjects will participate in two-week training sessions during 12 weeks.
      Independent of the group, participants will perform three water-based exercises: stationary
      running, frontal kick and cross-country skiing. The intensity of aerobic exercise will be
      based Rating Perceived Exertion (RPE). Along the training, the intensity of aerobic exercise
      will increase in both groups. Before and after intervention, there will be evaluation of
      muscle quality, muscle thickness, peak oxygen uptake and oxygen uptake at ventilatory
      threshold, maximal isometric and dynamic strength of knee extensors, maximal and submaximal
      isometric eletromiografy (EMG) activity of vastus lateralis and rectus femoris, muscle
      endurance, performance in functional tests and assessment of the perception of quality of
      life.

      Data will be analyzed by Generalized Estimating Equations (GEE) and Bonferroni's post-hoc
      test (α=0.05), including both protocol and intention to treat analyses (α=0,05).
Aging is associated with impairment in cardiorespiratory fitness, strength performance and
      muscle mass decrease, which affects the functional capacity of older adults directly.
      Consequently carrying out routine activities can be harmed. However regular exercise practice
      points out as an efficient tool to mitigate factors associated with aging.

      Therefore, carrying out water-based exercises has been widely suggested for older adults due
      to their advantages, such as low impact on lower limbs and lower cardiovascular load.

      The aim of the study is to investigate the effects of two water based aerobic training
      programs on cardiorespiratory, neuromuscular and quality of life parameters in old women.

      Volunteer old women age range: 60-75 years old, will participate to this study, and will
      randomly divided into two groups: continuous aerobic training group and interval aerobic
      training group.

      Both group subjects will participate in two-week training sessions during 12 weeks.
      Independent of the group, participants will perform three water-based exercises: stationary
      running, frontal kick and cross-country skiing. The intensity of aerobic exerecise will be
      based Rating Perceived Exertion (RPE). Along the training, the intensity of aerobic exercise
      will increase.

      Participants who will be randomized for the continuous aerobic training group will carry out
      exercises with no interval for exercise change. Intensity will be increased every mesocycle.
      In the first mesocycle (weeks 1-4), participants will carry out three 4-minute series of each
      exercise whose intensity corresponds to the Rating of Perceived Exertion (RPE) 13. In the
      second mesocycle (weeks 5-8), participants will perform four 3-minute series of each exercise
      corresponding to RPE 14. In the third mesocycle, participants will perform six 2-minute
      series of each exercise at intensity corresponding to RPE 15 from weeks 9-10, whereas
      intensity corresponding to RPE 16 will be experienced from weeks 11-12.

      Participants who will be randomized for interval aerobic training group will carry out
      exercises which associate effort phases, at higher intensity and recovery phases, at lower
      intensity, with no interval for exercise change. Intensity will be increased every mesocycle.
      The first mesocycle (weeks 1-4) comprises three 4-minute series of each exercise whose
      intensity corresponds to the RPE 16 for 2 minutes and RPE 11 for 2 minutes. The second
      mesocycle (weeks 5-8) includes four 3-minute series of each exercise whose intensity
      corresponds to the RPE 17 for 1.5 minutes and RPE 11 for 2 minutes. The third mesocycle
      (weeks 9-12) comprises six 2-minute series of each exercise whose intensity corresponds to
      the RPE 18 for 1 minute and RPE 11 for 1 minute.

      Before and after intervention, there will be evaluation of muscle quality, muscle thickness,
      peak oxygen uptake and oxygen uptake at ventilatory threshold, maximal isometric and dynamic
      strength of knee extensors, maximal and submaximal isometric eletromiografy (EMG) activity of
      vastus lateralis and rectus femoris, muscle endurance, performance in functional tests and
      assessment of the perception of quality of life.

      Data will be analyzed by Generalized Estimating Equations (GEE) and Bonferroni's post-hoc
      test (α=0.05), including both protocol and intention to treat analyses (α=0,05).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Cardiorespiratory Fitness evaluation change after 12 weeks
time frame: Testing of VO2peak change - Baseline and 12 week
description: We created a protocol on the treadmill to determine the peak oxygen uptake change(VO2peak), the first ventilatory threshold and the second ventilatory threshold. The protocol consists in 1-minute stages. The initial speed is 1.86 miles per hour. In each stage, the speed increases 0.3 miles per hour and every 2 stages, the treadmill inclination increases 1%. The test is interrupted when the subject indicates exhaustion. The respiratory gases will be collected through a portable gas analyzer (VO2000, MedGraphics, Ann Arbor, USA).
The maximum value of VO2 , closed to exhaustion will be considered the VO2peak. The fist and the second ventilatory threshold will be determined by the ventilation versus intensity curve and confirmed by the O2 and Carbon dioxide ventilatory equivalents by two independent physiologists in a visual inspection.
measure: Quality of Life change after 12 weeks (Score)
time frame: Baseline and 12 week
description: World Health Organization Quality of Life-bref - WHOQOL-bref
measure: Maximal dynamic strength change after 12 weeks (kg)
time frame: Baseline and 12 week
description: maximum repetition of knee extensors
measure: Maximal voluntary isometric contraction of knee extensors change after 12 weeks
time frame: Baseline and 12 week
description: electromyography
measure: muscle thickness of knee extensors change after 12 weeks
time frame: Baseline and 12 week
description: ultrasound image
measure: neuromuscular economy of vastus lateralis and rectus femoris change after 12 weeks
time frame: Baseline and 12 week
description: electromyography
measure: maximum muscular activity of vastus lateralis and rectus femoris change after 12 weeks
time frame: Baseline and 12 week
description: electromyography
arm group label: water-based continuous aerobic training
arm group type: Experimental
description: Participants who will be randomized for the intervention in the continuous aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-4), participants will carry out three 4-minute series of each exercise whose intensity corresponds to the Rating of Perceived Exertion (RPE) 13. In the second mesocycle (weeks 5-8), participants will perform four 3-minute series of each exercise corresponding to RPE 14. In the third mesocycle, participants will perform six 2-minute series of each exercise at intensity corresponding to RPE 15 from weeks 9-10, whereas intensity corresponding to RPE 16 will be experienced from weeks 11-12.
arm group label: water-based interval aerobic training
arm group type: Experimental
description: Participants who will be randomized for the intervention in the interval aerobic training group will carry out exercises which associate effort phases, at higher intensity and recovery phases, at lower intensity, with no interval for exercise change. Intensity will be increased every mesocycle. The first mesocycle (weeks 1-4) comprises three 4-minute series of each exercise whose intensity corresponds to the RPE 16 for 2 minutes and RPE 11 for 2 minutes. The second mesocycle (weeks 5-8) includes four 3-minute series of each exercise whose intensity corresponds to the RPE 17 for 1.5 minutes and RPE 11 for 2 minutes. The third mesocycle (weeks 9-12) comprises six 2-minute series of each exercise whose intensity corresponds to the RPE 18 for 1 minute and RPE 11 for 1 minute.
intervention type: Behavioral
intervention name: water-based continuous aerobic training
description: Participants who will be randomized for the continuous aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-4), participants will carry out three 4-minute series of each exercise whose intensity corresponds to the Rating of Perceived Exertion (RPE) 13. In the second mesocycle (weeks 5-8), participants will perform four 3-minute series of each exercise corresponding to RPE 14. In the third mesocycle, participants will perform six 2-minute series of each exercise at intensity corresponding to RPE 15 from weeks 9-10, whereas intensity corresponding to RPE 16 will be experienced from weeks 11-12.
arm group label: water-based continuous aerobic training
intervention type: Behavioral
intervention name: water-based interval aerobic training
description: Participants who will be randomized for interval aerobic training group will carry out exercises which associate effort phases, at higher intensity and recovery phases, at lower intensity, with no interval for exercise change. Intensity will be increased every mesocycle. The first mesocycle (weeks 1-4) comprises three 4-minute series of each exercise whose intensity corresponds to the RPE 16 for 2 minutes and RPE 11 for 2 minutes. The second mesocycle (weeks 5-8) includes four 3-minute series of each exercise whose intensity corresponds to the RPE 17 for 1.5 minutes and RPE 11 for 2 minutes. The third mesocycle (weeks 9-12) comprises six 2-minute series of each exercise whose intensity corresponds to the RPE 18 for 1 minute and RPE 11 for 1 minute.
arm group label: water-based interval aerobic training
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cristine Alberton, Phd
role: Principal Investigator
affiliation: UFPel
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Pelotas
investigator full name: Stephanie Santana Pinto
investigator title: Professor in Physical Education School