Community-Based Participatory ResearchNCT02126410
Associations Between Self-Reported Sleep Duration and Sarcopenia in Community-Dwelling Older Adults
An observational study of Community-Based Participatory Research and Aged, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. BACKGROUNDS: Currently, elderly people comprise more than 10% of the total Taiwanese population. However, within the context of self-reported sleep duration and health risks, research into the association between sleep duration and body composition changes in older people is limited. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-Based Participatory Research, Aged, Sleep
- How many people
- 488 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: community-dwelling elderly (>= 65 years old)
- hyper- or hypothyroidism.
- taking prescribed medications (such as growth hormone, testosterone, or progesterone) known to alter body composition.
- any condition that prevented them from completing our questionnaires or the functional capacity test (e.g., amputee, nonambulatory even with the use of a walker or a cane, blind, or deaf).
Trial locations and contacts
1 site in 1 country.
About this study
- BACKGROUNDS: Currently, elderly people comprise more than 10% of the total Taiwanese population. However, within the context of self-reported sleep duration and health risks, research into the association between sleep duration and body composition changes in older people is limited. It is important to gain an understanding of such an association of older people to estimate the public health burden.
- OBJECTIVES: To assess the association between self-reported sleep duration and sarcopenia as well as obesity in community-dwelling older adults.
- HYPOTHESIS: Self-reported sleep duration is associated with prevalence of sarcopenia and obesity in community-dwelling older adults.
- DESIGN: A cross-sectional investigation.
- SETTING: Communities in Zhongzheng district, Taipei.
- PARTICIPANTS: Four hundred and forty-eight community-dwelling adults (224 men and 264 women) aged 65 years and older.
- MEASUREMENTS: The investigators evaluated self-reported sleep duration by deriving from the Pittsburgh Sleep Quality Index and 7-d recall physical activity diary. Skeletal muscle mass was estimated by the predicted equation from a bioelectrical impedance analysis measurement. The Groningen Activity Restriction Scale and the Chinese Geriatric Depression Screening Scale were used to evaluate physical disability and depression, respectively.
- Conditions
- Community-Based Participatory Research, Aged, Sleep, Body Composition
- Keywords
- sarcopenia, sleep duration, body composition, skeletal muscle
- Medical subject headings
- Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle mass index
Using Bioelectrical Impedance Analysis to measure skeletal muscle mass (kg) and further calculate skeletal muscle mass index to investigate the prevalence of sarcopenia.
Measured: one day
Secondary outcomes (4)
Sleep quality
Using Pittsburgh Sleep Quality Index to record the sleep quality
Measured: one day
Level of physical activity
Using 7-d recall physical activity questionnaire to evaluate general physical activity in the past 7 days.
Measured: one day
Sleep duration
Recording the sleep time at night and daytime napping separately.
Measured: one day
Body composition
Using Bioelectrical Impedance Analysis to measure fat percentage in all subjects.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Based Participatory ResearchStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng-Yueh Chien, Ph.D, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126410
- Sponsor's protocol ID
- 201402038RINB
- Status last verified
- Aug 2014
- First submitted
- 24 Apr 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Self-Reported Sleep Duration and Sarcopenia in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT02126410
- Acronym / sponsor ID
- 201402038RINB
- Conditions
- Community-Based Participatory Research, Aged, Sleep, Body Composition
- Keywords
- sarcopenia, sleep duration, body composition, skeletal muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- BACKGROUNDS: Currently, elderly people comprise more than 10% of the total Taiwanese population. However, within the context of self-reported sleep duration and health risks, research into the association between sleep duration and body composition changes in older people is limited. It is important to gain an understanding of such an association of older people to estimate the public health burden.
- OBJECTIVES: To assess the association between self-reported sleep duration and sarcopenia as well as obesity in community-dwelling older adults.
- HYPOTHESIS: Self-reported sleep duration is associated with prevalence of sarcopenia and obesity in community-dwelling older adults.
- DESIGN: A cross-sectional investigation.
- SETTING: Communities in Zhongzheng district, Taipei.
- PARTICIPANTS: Four hundred and forty-eight community-dwelling adults (224 men and 264 women) aged 65 years and older.
- MEASUREMENTS: The investigators evaluated self-reported sleep duration by deriving from the Pittsburgh Sleep Quality Index and 7-d recall physical activity diary. Skeletal muscle mass was estimated by the predicted equation from a bioelectrical impedance analysis measurement. The Groningen Activity Restriction Scale and the Chinese Geriatric Depression Screening Scale were used to evaluate physical disability and depression, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- community-dwelling elderly (>= 65 years old)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skeletal muscle mass index
Time frame: one day
Using Bioelectrical Impedance Analysis to measure skeletal muscle mass (kg) and further calculate skeletal muscle mass index to investigate the prevalence of sarcopenia.
4 secondary outcomes
Sleep quality
Time frame: one day
Level of physical activity
Time frame: one day
Sleep duration
Time frame: one day
Body composition
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng-Yueh Chien, Ph.D principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Based Participatory Research and Aged, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle mass index (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.