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

NCT02779088 | Completed

• 1 other identifier: 201601091RIND
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

physical fitness,body composition,sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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

  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

  At the baseline, 1st follow-up (12 weeks) and 2nd follow-up (26 weeks) after the whole intervention process

Secondary Outcomes (3)

• 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

• 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 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

Study Arms (2)

Early exercise and nutrition

EXPERIMENTAL

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.

Other: exercise and nutrition

Delayed exercise and nutrition

ACTIVE COMPARATOR

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.

Other: exercise and nutrition

Interventions

exercise and nutrition 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; Early exercise and nutrition

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 32723507 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise; Nutritional Status

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Der-Sheng Han MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigator don't know which group the participants are assigned to before randomization.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 20, 2016
• Study Start: April 24, 2016
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: October 6, 2020

Record last verified: 2019-03

Locations

TW (1)