SarcopeniaNCT02779088
The Physical Fitness Cohort Study in the Community-dwelling Elderly in the WanHwa Area.
A study testing exercise and nutrition in people with Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- exercise and nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2016to 22 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Physical Medicine and Rehabilitation,National Taiwan University Hosptial,Bei-Hu Brance and National Taiwan University College of Medicine,Taipei,Taiwan
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- exercise and nutrition
- Keywords
- physical fitness,body composition,sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and nutritionOther
Exercise:muscle strengthening exercise Nutrition: 7.2 g branched chain amino acid every day and 1200 mg Ca+800 IU Vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: exercise and nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
The investigators want to measure the correlation of Terra RNA with physical fitness and other components of body compositions.
Measured: 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
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
Measured: At the baseline, either at 1st follow-up (12 weeks) or 2nd follow-up (26 weeks) after the whole intervention process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start24 Apr 2016
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Der-Sheng Han MD, PhD, Principal investigator, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital BeiHu Brance,Taipei
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779088
- Sponsor's protocol ID
- 201601091RIND
- Status last verified
- Mar 2019
- First submitted
- 18 May 2016
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32723507
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Physical Medicine and Rehabilitation,National Taiwan University Hosptial,Bei-Hu Brance and National Taiwan University College of Medicine,Taipei,Taiwan
- ClinicalTrials.gov ID
- NCT02779088
- Acronym / sponsor ID
- 201601091RIND
- Conditions
- Sarcopenia
- Keywords
- physical fitness,body composition,sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Apr 2016 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early exercise and nutrition | Experimental | Other: exercise and nutritionEnrolled 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. |
| Delayed exercise and nutrition | Active comparator | Other: exercise and nutritionEnrolled 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise and nutritionExercise:muscle strengthening exercise Nutrition: 7.2 g branched chain amino acid every day and 1200 mg Ca+800 IU Vitamin D3 | Other | Delayed exercise and nutrition, Early exercise and nutrition |
Primary outcome
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
3 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
Time frame: 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
Time frame: 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
Time frame: At the baseline, either at 1st follow-up (12 weeks) or 2nd follow-up (26 weeks) after the whole intervention process
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 32723507Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Der-Sheng Han MD, PhD principal investigator
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital BeiHu Brance,Taipei
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and nutrition in people with Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02779088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.