The Physical Fitness Cohort Study in the Community-dwelling Elderly in the WanHwa Area.

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Other: exercise and nutrition

• Registration Number: NCT02779088
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The aims of this study are to establish the cohort of elder population based on parameters of health-related fitness, body compositions, blood biochemistry, blood biomarker, balance, quality of life, and musculoskeletal ultrasonography; and to evaluate the association between fitness parameters and disease incidence with those data.

Detailed Description

The aims of this study are to establish the cohort of elder population based on parameters of health-related fitness, body compositions, blood biochemistry, blood biomarker, balance, quality of life, and musculoskeletal ultrasonography and to evaluate the association between fitness parameters and disease incidence with these data. We expect to recruit 1200 adults who attend the annual health check-up in National Taiwan University, BeiHu Branch in 2016 and 2017 and to train 60 individuals having sarcopenia with strengthening exercise. This study will establish the urban elderly cohort, measure both physical and functional parameters, find the risk factors for aging, and validate the role of strength training for those sarcopenia patients. We hope this study will be widely cited in related fields in the future.

Study Timeline

• Study Start: 2016-04-24
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-20
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Status Verified: 2019-03
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed exercise and nutrition	exercise and nutrition	Enrolled participants with sarcopenia will be randomized to receive either strengthening exercise and nutrition or education courses (DVD and handbook) first and then will receive the opposite intervention subsequently. The study will consist of two periods of 12 weeks separated by a washout period of 2 weeks. It's the AB/BA study. Subjects in the BA arm receive the education course first, followed by exercise and nutrition.
Early exercise and nutrition	exercise and nutrition	Enrolled participants with sarcopenia will be randomized to receive either strengthening exercise and nutrition or education courses (DVD and handbook) first and then will receive the opposite intervention subsequently. The study will consist of two periods of 12 weeks separated by a washout period of 2 weeks. It's the AB/BA study. Subjects in the AB arm receive exercise and nutrition intervention first, followed by the education course.

Primary Outcome Measures

Name	Time	Method
Change from skeletal muscle mass,grip and pace between the baseline, 1st follow-up (12 weeks) and 2nd follow-up (26 weeks) after the whole intervention process	At the baseline, 1st follow-up (12 weeks) and 2nd follow-up (26 weeks) after the whole intervention process	Skeletal muscle mass,grip and pace were assessed the baseline, 1st follow-up (12 weeks) and 2nd follow-up (26 weeks) after the whole intervention process

Secondary Outcome Measures

Name	Time	Method
Change from telomere's length at the baseline, 1st follow-up (12 weeks) and 2nd follow-up (26 weeks) after the whole intervention process	At the baseline, either at 1st follow-up (12 weeks) or 2nd follow-up (26 weeks) after the whole intervention process	The investigators want to measure the change of telomere's length at the baseline and , either at 1st follow-up (12 weeks) or 2nd follow-up (26 weeks) after the whole intervention process
Change of Terra RNA, physical fitness and other components of body compositions at the baseline, either at 1st follow-up (12 weeks) or 2nd follow-up (26 weeks) after the whole intervention process	at the baseline, either at 1st follow-up (12 weeks) or 2nd follow-up (26 weeks) after the whole intervention process	The investigators want to measure the correlation of Terra RNA with physical fitness and other components of body compositions.
the difference of ECV at the baseline, 1st follow-up (12 weeks) and 2nd follow-up (26 weeks) after the whole intervention process	At the baseline, either at 1st follow-up (12 weeks) or 2nd follow-up (26 weeks) after the whole intervention process	The investigators want to measure the difference of ECV at the baseline, either at 1st follow-up (12 weeks) or 2nd follow-up (26 weeks) after the whole intervention process

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan