Department of Physical Medicine and Rehabilitation,National Taiwan University Hosptial,Bei-Hu Brance and National Taiwan University College of Medicine,Taipei,Taiwan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
Participants and investigator don't know which group the participants are assigned to before randomization.
Eligibility Criteria
- Ages
- 65 Years to 100 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
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.
Intervention: exercise and nutrition (Other)
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.
Intervention: exercise and nutrition (Other)
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- 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)