NCT02126410

Brief Summary

  1. 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. It is important to gain an understanding of such an association of older people to estimate the public health burden.
  2. 2.OBJECTIVES: To assess the association between self-reported sleep duration and sarcopenia as well as obesity in community-dwelling older adults.
  3. 3.HYPOTHESIS: Self-reported sleep duration is associated with prevalence of sarcopenia and obesity in community-dwelling older adults.
  4. 4.DESIGN: A cross-sectional investigation.
  5. 5.SETTING: Communities in Zhongzheng district, Taipei.
  6. 6.PARTICIPANTS: Four hundred and forty-eight community-dwelling adults (224 men and 264 women) aged 65 years and older.
  7. 7.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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
488

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

April 24, 2014

Last Update Submit

August 11, 2014

Conditions

Keywords

sarcopeniasleep durationbody compositionskeletal muscle

Outcome Measures

Primary Outcomes (1)

  • 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.

    one day

Secondary Outcomes (4)

  • Sleep quality

    one day

  • Level of physical activity

    one day

  • Sleep duration

    one day

  • Body composition

    one day

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

community-dwelling elderly (\>= 65 years old)

1. hyper- or hypothyroidism. 2. taking prescribed medications (such as growth hormone, testosterone, or progesterone) known to alter body composition. 3. 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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Meng-Yueh Chien, Ph.D

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 30, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations