<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/NCT04427696</url>
  </required_header>
  <id_info>
    <org_study_id>2018/421</org_study_id>
    <nct_id>NCT04427696</nct_id>
  </id_info>
  <brief_title>The Effect of Walking Exercise on Sleep Quality in Sedentary Healthy Adults</brief_title>
  <official_title>The Effect of Walking Exercise on Sleep Quality in Sedentary Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Feifei Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eotvos Lorand University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study is to examine the effect of one-hour walking exercise on sleep&#xD;
      quality in adults. The second goal of this study is to explore a feasible exercise method to&#xD;
      promote sleep quality to all age groups, in order to improve sleep quality in overall&#xD;
      population. The study attempts to unfold how the daily exercise, such as walking, benefits&#xD;
      sleep quality. This study hypothesis that one-hour walking improves sleep quality in general&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to test the hypothesis that walking exercise improves sleep quality in general&#xD;
      population, the investigators conducted a randomized (case-control) cross-over trial. The&#xD;
      targeted population is the physically and mentally healthy adults (18+). The health status&#xD;
      was self-reported, the investigators did not organize physical and mental examination for&#xD;
      participants in this study. The investigators recruited participants both online and&#xD;
      off-line. The call-for-participants advertisement distributed in social media platforms such&#xD;
      as Facebook, WeChat etc.&#xD;
&#xD;
      There were two groups in this study: walking group, and control group. The&#xD;
      call-for-participants advertisement was distributed through online platforms and by posters.&#xD;
      In the advertisement, all people were welcomed to participate, after receiving the&#xD;
      applications, the investigators assessed the participant. In order to test the hypothesis&#xD;
      that walking exercise improve sleep quality in general population, the investigators&#xD;
      conducted a randomized (case-control) cross-over trial.&#xD;
&#xD;
      Participants can only be accepted after approval from the research team who performed the&#xD;
      group discussion and evaluation of the sedentary behavior. If the participants meet the&#xD;
      sedentary criteria, the participants would be informed the consent and terms and conditions&#xD;
      to participate the study. Participants were randimzed into two groups by lottery&#xD;
      (intervention and control group). The first phase intervention lasted for four weeks. At the&#xD;
      beginning and at end of the intervention, the investigators assessed the sleep quality of&#xD;
      participants by the Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS) and&#xD;
      Satisfaction With Life Scale (SWLS). The second phase was a wash period (4-week) and the&#xD;
      third phase was a 4-week intervention. It has to be noted that at the beginning of the third&#xD;
      phase, the participants in the two groups exchanged their role to receive active&#xD;
      interventions. Participants in each group were coded by an autonomous number with characters.&#xD;
&#xD;
      Walking exercise was self-controlled and tracked by daily dairy and pedometers. All of the&#xD;
      participants are obligated to record the start and end time of walking every day. And&#xD;
      pedometers (mode: Omron HJ-112) were used for tracking walking steps including heart rate,&#xD;
      calories and miles. For the ones who were in the control group, they had to keep sedentary&#xD;
      lifestyle.&#xD;
&#xD;
      The participants had the responsibility to carry out the walking practice every day in the&#xD;
      first and third phase. Every participant was counselled and gave their written informed&#xD;
      consent before entering into the trial. The participation of this project was voluntary,&#xD;
      unpaid. During the trial, all participants were free to quit the project with reasonable&#xD;
      reasons, the investigators will not force anyone to continue the project if they cannot&#xD;
      insist on. The investigators would inform the results of the first phase if the participant&#xD;
      requests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">May 26, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>12 weeks</time_frame>
    <description>Sleep quality is measured by Pittsburgh Sleep Quality Index, the score of which ranges from 0 to 21. If the score is less than 5, it indicates good sleeper, otherwise, it will be indicated as poor sleeper. Overall, higher score, poorer sleep quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress</measure>
    <time_frame>12 weeks</time_frame>
    <description>Stress is measured by Perceived Stress Scale . Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Life satisfaction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Life satisfaction is assessed by Satisfaction With Life Scale. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>12 weeks</time_frame>
    <description>cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Walking</condition>
  <condition>Sleep</condition>
  <condition>Stress, Psychological</condition>
  <condition>Lifestyle, Sedentary</condition>
  <condition>Life Change Events</condition>
  <arm_group>
    <arm_group_label>Aerobic walking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants in this arm were obligated to carry out one hour aerobic walking (goal setting walking) daily. The goal of aerobic walking: 1. at least 60 steps per minute; 2. continuously walking for 10 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No aerobic walking</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The participants in this arm were requested to maintain sedentary life, without joining other physical exercise programmes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic walking intervention</intervention_name>
    <description>Walking exercise is self-controlled and tracked by daily dairy. All of the participants are obligated to record the start and end time of walking every day. And pedometers will be used for tracking walking steps including heart rate and calories. We plan to use pedometer in our study, which was reported the most accurate pedometer and suitable for scientific research. For the ones who are in the control group, they have to keep sedentary lifestyle, and no regular walking exercise, and they are agree to be in the comparable members in our study.</description>
    <arm_group_label>Aerobic walking</arm_group_label>
    <arm_group_label>No aerobic walking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 18-60 years old&#xD;
&#xD;
          -  without physical or metal diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People who responded to join the study were screened either online or face-to-face by&#xD;
             two principal questions: 1: Do you participate in any kind of regular exercise&#xD;
             programs (weight-lifting, walking, running, swimming etc.)? 2. Are you involved in any&#xD;
             physical or sport teams? If the respondent answered &quot;Yes&quot; to at least one of the&#xD;
             questions, he/she would be excluded from the study because it could interfere with the&#xD;
             effect of intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Feifei Wang</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Eotvos Lorand University</investigator_affiliation>
    <investigator_full_name>Feifei Wang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not plan for making IPD available to other researchers, as it has been confirmed in the consent form. What we can share is the result of the whole intervention study and intervention process.</ipd_description>
  </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/NCT04427696
org study id: 2018/421
nct id: NCT04427696
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary goal of this study is to examine the effect of one-hour walking exercise on sleep
      quality in adults. The second goal of this study is to explore a feasible exercise method to
      promote sleep quality to all age groups, in order to improve sleep quality in overall
      population. The study attempts to unfold how the daily exercise, such as walking, benefits
      sleep quality. This study hypothesis that one-hour walking improves sleep quality in general
      population.
In order to test the hypothesis that walking exercise improves sleep quality in general
      population, the investigators conducted a randomized (case-control) cross-over trial. The
      targeted population is the physically and mentally healthy adults (18+). The health status
      was self-reported, the investigators did not organize physical and mental examination for
      participants in this study. The investigators recruited participants both online and
      off-line. The call-for-participants advertisement distributed in social media platforms such
      as Facebook, WeChat etc.

      There were two groups in this study: walking group, and control group. The
      call-for-participants advertisement was distributed through online platforms and by posters.
      In the advertisement, all people were welcomed to participate, after receiving the
      applications, the investigators assessed the participant. In order to test the hypothesis
      that walking exercise improve sleep quality in general population, the investigators
      conducted a randomized (case-control) cross-over trial.

      Participants can only be accepted after approval from the research team who performed the
      group discussion and evaluation of the sedentary behavior. If the participants meet the
      sedentary criteria, the participants would be informed the consent and terms and conditions
      to participate the study. Participants were randimzed into two groups by lottery
      (intervention and control group). The first phase intervention lasted for four weeks. At the
      beginning and at end of the intervention, the investigators assessed the sleep quality of
      participants by the Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS) and
      Satisfaction With Life Scale (SWLS). The second phase was a wash period (4-week) and the
      third phase was a 4-week intervention. It has to be noted that at the beginning of the third
      phase, the participants in the two groups exchanged their role to receive active
      interventions. Participants in each group were coded by an autonomous number with characters.

      Walking exercise was self-controlled and tracked by daily dairy and pedometers. All of the
      participants are obligated to record the start and end time of walking every day. And
      pedometers (mode: Omron HJ-112) were used for tracking walking steps including heart rate,
      calories and miles. For the ones who were in the control group, they had to keep sedentary
      lifestyle.

      The participants had the responsibility to carry out the walking practice every day in the
      first and third phase. Every participant was counselled and gave their written informed
      consent before entering into the trial. The participation of this project was voluntary,
      unpaid. During the trial, all participants were free to quit the project with reasonable
      reasons, the investigators will not force anyone to continue the project if they cannot
      insist on. The investigators would inform the results of the first phase if the participant
      requests.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Sleep quality
time frame: 12 weeks
description: Sleep quality is measured by Pittsburgh Sleep Quality Index, the score of which ranges from 0 to 21. If the score is less than 5, it indicates good sleeper, otherwise, it will be indicated as poor sleeper. Overall, higher score, poorer sleep quality.
measure: Stress
time frame: 12 weeks
description: Stress is measured by Perceived Stress Scale . Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
measure: Life satisfaction
time frame: 12 weeks
description: Life satisfaction is assessed by Satisfaction With Life Scale. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree.
measure: Height
time frame: 12 weeks
description: cm
measure: Weight
time frame: 12 weeks
description: kg
arm group label: Aerobic walking
arm group type: Active Comparator
description: The participants in this arm were obligated to carry out one hour aerobic walking (goal setting walking) daily. The goal of aerobic walking: 1. at least 60 steps per minute; 2. continuously walking for 10 minutes.
arm group label: No aerobic walking
arm group type: Placebo Comparator
description: The participants in this arm were requested to maintain sedentary life, without joining other physical exercise programmes.
intervention type: Behavioral
intervention name: Aerobic walking intervention
description: Walking exercise is self-controlled and tracked by daily dairy. All of the participants are obligated to record the start and end time of walking every day. And pedometers will be used for tracking walking steps including heart rate and calories. We plan to use pedometer in our study, which was reported the most accurate pedometer and suitable for scientific research. For the ones who are in the control group, they have to keep sedentary lifestyle, and no regular walking exercise, and they are agree to be in the comparable members in our study.
arm group label: Aerobic walking
arm group label: No aerobic walking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Hungary
responsible party type: Sponsor-Investigator
investigator affiliation: Eotvos Lorand University
investigator full name: Feifei Wang
investigator title: Principal Investigator
mesh term: Stress, Psychological
sharing ipd: No
ipd description: There is not plan for making IPD available to other researchers, as it has been confirmed in the consent form. What we can share is the result of the whole intervention study and intervention process.