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

NCT ID: NCT02779088

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-24

Study Completion Date

2019-01-22

Brief Summary

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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

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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.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators invited around 60 persons with sarcopenia by telephone to attend the study and randomly assigned them to group A and B (around 30 persons in each). Group A first accepted exercise and nutrition intervention and then was given the education course. Group B was treated in the reversed order.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Participants and investigator don't know which group the participants are assigned to before randomization.

Study Groups

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Early 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.

Group Type EXPERIMENTAL

exercise and nutrition

Intervention Type OTHER

Exercise:muscle strengthening exercise Nutrition: 7.2 g branched chain amino acid every day and 1200 mg Ca+800 IU Vitamin D3

Delayed 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.

Group Type ACTIVE_COMPARATOR

exercise and nutrition

Intervention Type OTHER

Exercise:muscle strengthening exercise Nutrition: 7.2 g branched chain amino acid every day and 1200 mg Ca+800 IU Vitamin D3

Interventions

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exercise and nutrition

Exercise:muscle strengthening exercise Nutrition: 7.2 g branched chain amino acid every day and 1200 mg Ca+800 IU Vitamin D3

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

The investigators are ready to find out the individuals aged above 65 years and having sarcopenia. The 60 individuals must be evaluated their physical fitness in advance. The investigators plan to perform exercise and nutrition intervention for the individuals.

Exclusion Criteria

1. Patients with heart rhythm, atrial fibrillation, ventricular bigeminy, infections, tumors, and blood disease,etc.
2. Individuals has lived in nursing home or long-term care institutions.
3. Individuals cannot stand steadily. 4 Individuals cannot fill the questionnaires by his own.
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Der-Sheng Han MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital BeiHu Brance,Taipei

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Chang KV, Wu WT, Huang KC, Han DS. Effectiveness of early versus delayed exercise and nutritional intervention on segmental body composition of sarcopenic elders - A randomized controlled trial. Clin Nutr. 2021 Mar;40(3):1052-1059. doi: 10.1016/j.clnu.2020.06.037. Epub 2020 Jul 14.

Reference Type DERIVED
PMID: 32723507 (View on PubMed)

Other Identifiers

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201601091RIND

Identifier Type: -

Identifier Source: org_study_id

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