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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02126410
Other study ID # 201402038RINB
Secondary ID
Status Completed
Phase N/A
First received April 24, 2014
Last updated August 11, 2014
Start date March 2014
Est. completion date August 2014

Study information

Verified date August 2014
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical 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. It is important to gain an understanding of such an association of older people to estimate the public health burden.

2. OBJECTIVES: To assess the association between self-reported sleep duration and sarcopenia as well as obesity in community-dwelling older adults.

3. HYPOTHESIS: Self-reported sleep duration is associated with prevalence of sarcopenia and obesity in community-dwelling older adults.

4. DESIGN: A cross-sectional investigation.

5. SETTING: Communities in Zhongzheng district, Taipei.

6. PARTICIPANTS: Four hundred and forty-eight community-dwelling adults (224 men and 264 women) aged 65 years and older.

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.


Recruitment information / eligibility

Status Completed
Enrollment 488
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility 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).

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Sleep quality Using Pittsburgh Sleep Quality Index to record the sleep quality one day No
Secondary Level of physical activity Using 7-d recall physical activity questionnaire to evaluate general physical activity in the past 7 days. one day No
Secondary Sleep duration Recording the sleep time at night and daytime napping separately. one day No
Secondary Body composition Using Bioelectrical Impedance Analysis to measure fat percentage in all subjects. one day No
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