NCT04427696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 8, 2020

Last Update Submit

June 9, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    12 weeks

  • 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.

    12 weeks

  • 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.

    12 weeks

Secondary Outcomes (2)

  • Height

    12 weeks

  • Weight

    12 weeks

Study Arms (2)

Aerobic walking

ACTIVE COMPARATOR

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.

Behavioral: Aerobic walking intervention

No aerobic walking

PLACEBO COMPARATOR

The participants in this arm were requested to maintain sedentary life, without joining other physical exercise programmes.

Behavioral: Aerobic walking intervention

Interventions

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.

Aerobic walkingNo aerobic walking

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between 18-60 years old
  • without physical or metal diseases

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feifei Wang

Budapest, Hungary

Location

MeSH Terms

Conditions

Stress, PsychologicalSedentary Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

January 1, 2019

Primary Completion

March 31, 2019

Study Completion

May 26, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

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.

Locations