The Effect of Walking Exercise on Sleep Quality in Sedentary Healthy Adults
Primary Purpose
Walking, Sleep, Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Aerobic walking intervention
Sponsored by
About this trial
This is an interventional health services research trial for Walking
Eligibility Criteria
Inclusion Criteria:
- between 18-60 years old
- without physical or metal diseases
Exclusion Criteria:
- People who responded to join the study were screened either online or face-to-face by two principal questions: 1: Do you participate in any kind of regular exercise programs (weight-lifting, walking, running, swimming etc.)? 2. Are you involved in any physical or sport teams? If the respondent answered "Yes" to at least one of the questions, he/she would be excluded from the study because it could interfere with the effect of intervention.
Sites / Locations
- Feifei Wang
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aerobic walking
No aerobic walking
Arm 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.
The participants in this arm were requested to maintain sedentary life, without joining other physical exercise programmes.
Outcomes
Primary Outcome Measures
Sleep quality
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.
Stress
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.
Life satisfaction
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.
Secondary Outcome Measures
Height
cm
Weight
kg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04427696
Brief Title
The Effect of Walking Exercise on Sleep Quality in Sedentary Healthy Adults
Official Title
The Effect of Walking Exercise on Sleep Quality in Sedentary Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
May 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Feifei Wang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Walking, Sleep, Stress, Psychological, Lifestyle, Sedentary, Life Change Events
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic walking
Arm Type
Active Comparator
Arm 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 Title
No aerobic walking
Arm Type
Placebo Comparator
Arm Description
The participants in this arm were requested to maintain sedentary life, without joining other physical exercise programmes.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic walking intervention
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.
Primary Outcome Measure Information:
Title
Sleep quality
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.
Time Frame
12 weeks
Title
Stress
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.
Time Frame
12 weeks
Title
Life satisfaction
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Height
Description
cm
Time Frame
12 weeks
Title
Weight
Description
kg
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
between 18-60 years old
without physical or metal diseases
Exclusion Criteria:
People who responded to join the study were screened either online or face-to-face by two principal questions: 1: Do you participate in any kind of regular exercise programs (weight-lifting, walking, running, swimming etc.)? 2. Are you involved in any physical or sport teams? If the respondent answered "Yes" to at least one of the questions, he/she would be excluded from the study because it could interfere with the effect of intervention.
Facility Information:
Facility Name
Feifei Wang
City
Budapest
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan 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.
Learn more about this trial
The Effect of Walking Exercise on Sleep Quality in Sedentary Healthy Adults
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