SarcopeniaNCT04777279
Physical Exercise, Nutrition Supplement and Frailty of Older Population
A study testing individual physical exercise group, individual Branched-Chain Amino Acids supplements group and combination of physical exercise and nutrition supplements group in people with Sarcopenia and Physical Exercise, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This study is aimed to explore the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life in community-dwelling older population. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia, Physical Exercise, Nutrition Poor
- What is being tested?
- individual physical exercise group, individual Branched-Chain Amino Acids supplements group and combination of physical exercise and nutrition supplements group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2020to 30 Aug 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older adults aged more than 60 years;
- pre-frail stage: must have one item as frailty identified using the Fried's phenotype method;
- normal cognition: AD8 score less than 2 points;
- can communicate with Mandarin or Taiwanese.
Who cannot join
- incapable of walk independent or using assistive devices (e.g., crutches);
- a condition of having an acute disease, hemodialysis, or unable to engage in physical activity;
- have history of unstable heart disease such as coronary heart disease, heart failure and hypertension without regular medication;
- have regular physical activity (≥150 minutes weekly) such as aerobic dance, swimming, Tai Chi.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Exercise and Nutrition Supplement on Improving Frailty, Depressive Symptoms, and Quality of Life in Community-dwelling Older Population
This study is aimed to explore the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life in community-dwelling older population.
Read the detailed description
Objective: This study is aimed to explore the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life in community-dwelling older population.
Methods: We conduct a quasi-experimental study to measure frailty, depressive symptoms, and quality of life before and after intervention. A total of 120 community-living older adults with frailty identified by Fried's phenotype method are assigned to four groups: physical exercise group, nutrition supplements group, physical exercise and nutrition supplements group, and control group. Each participants in the assigned group will receive 12 weeks intervention. Measurements include frailty (Fried's phenotype method), depressive symptoms (Geriatric Depression Scale-15, GDS-15), and quality of life (WHOQOL-BREF). Data analyses include describe statistics, Chi-square test, and Analysis of Variance. A Generalized estimating equations (GEE) will be used to examine the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life.
- Conditions
- Sarcopenia, Physical Exercise, Nutrition Poor, Elderly
- Being tested
- individual physical exercise group, individual Branched-Chain Amino Acids supplements group, combination of physical exercise and nutrition supplements group
- Medical subject headings
- Sarcopenia, Motor Activity, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual physical exercise groupBehavioural
The participants in physical exercise group will receiving individual physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks.
individual Branched-Chain Amino Acids supplements groupDietary supplement
The participants in nutrition supplements group will receiving Branched-Chain Amino Acids 5 g Branched-Chain Amino Acids every day for 12 weeks.
combination of physical exercise and nutrition supplements groupOther
The participants in physical exercise group will receiving physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks and 5 g Branched-Chain Amino Acids every day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Individual physical exercise group | Experimental | a 12-weeks physical exercise program (60 minutes/ three times weekly) Receives: Behavioral: individual physical exercise group |
| Individual Branched-Chain Amino Acids supplements group | Experimental | a 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day) Receives: Dietary Supplement: individual Branched-Chain Amino Acids supplements group |
| Combination of physical exercise and Branched-Chain Amino Acids supplements group | Experimental | a 12-weeks physical exercise program (60 minutes/ three times weekly) and a 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day) Receives: Other: combination of physical exercise and nutrition supplements group |
| Control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
frailty score
Frailty will examined using Fried's phenotype method and higher score indicates more frailty
Measured: frailty score at baseline
frailty score
Frailty will examined using Fried's phenotype method and higher score indicates more frailty
Measured: through study completion, an average of 12 weeks
Secondary outcomes (4)
Depressive symptoms score
Depression will measured using Geriatric Depression Scale-15 (GDS-15) and and higher score indicates more depression
Measured: Depressive symptoms at baseline
Depressive symptoms score
Depression will measured using Geriatric Depression Scale-15.
Measured: through study completion, an average of 12 weeks
Quality of Life score
Quality of Life will examined using World Health Organization Quality of Life scale and higher score indicate better quality of life
Measured: Quality of Life at baseline
Quality of Life score
Quality of Life will examined using World Health Organization Quality of Life scale and higher score indicate better quality of life
Measured: through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start9 Dec 2020
- Primary completion30 Jul 2021
- Study completion30 Aug 2021
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 Taipei Medical UniversityThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang, Hui-Chuan, Taipei Medical University
- Investigators
- Hui-Chuan Huang, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777279
- Sponsor's protocol ID
- N202010046
- Status last verified
- Mar 2022
- First submitted
- 26 Jan 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen LF, Chang HC, Cai ZC, Chen YJ, Hsu WL, Chuang YH, Lee SC, Huang HC. Community-based exercise and nutritional interventions to improve frailty syndrome among older adults: A quasi-experimental study. Geriatr Nurs. 2023 May-Jun;51:222-231. doi: 10.1016/j.gerinurse.2023.03.016. Epub 2023 Apr 3.
PubMed 37018848
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise and Nutrition Supplement on Improving Frailty, Depressive Symptoms, and Quality of Life in Community-dwelling Older Population
- ClinicalTrials.gov ID
- NCT04777279
- Acronym / sponsor ID
- N202010046
- Conditions
- Sarcopenia, Physical Exercise, Nutrition Poor, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- 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.
This study is aimed to explore the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life in community-dwelling older population.
Detailed description
Objective: This study is aimed to explore the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life in community-dwelling older population.
Methods: We conduct a quasi-experimental study to measure frailty, depressive symptoms, and quality of life before and after intervention. A total of 120 community-living older adults with frailty identified by Fried's phenotype method are assigned to four groups: physical exercise group, nutrition supplements group, physical exercise and nutrition supplements group, and control group. Each participants in the assigned group will receive 12 weeks intervention. Measurements include frailty (Fried's phenotype method), depressive symptoms (Geriatric Depression Scale-15, GDS-15), and quality of life (WHOQOL-BREF). Data analyses include describe statistics, Chi-square test, and Analysis of Variance. A Generalized estimating equations (GEE) will be used to examine the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individual physical exercise group | Experimental | Behavioral: individual physical exercise groupa 12-weeks physical exercise program (60 minutes/ three times weekly) |
| Individual Branched-Chain Amino Acids supplements group | Experimental | Dietary Supplement: individual Branched-Chain Amino Acids supplements groupa 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day) |
| Combination of physical exercise and Branched-Chain Amino Acids supplements group | Experimental | Other: combination of physical exercise and nutrition supplements groupa 12-weeks physical exercise program (60 minutes/ three times weekly) and a 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day) |
| Control group | No intervention | –no intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older adults aged more than 60 years;
- pre-frail stage: must have one item as frailty identified using the Fried's phenotype method;
- normal cognition: AD8 score less than 2 points;
- can communicate with Mandarin or Taiwanese.
Key exclusion criteria (4 listed)
- incapable of walk independent or using assistive devices (e.g., crutches);
- a condition of having an acute disease, hemodialysis, or unable to engage in physical activity;
- have history of unstable heart disease such as coronary heart disease, heart failure and hypertension without regular medication;
- have regular physical activity (≥150 minutes weekly) such as aerobic dance, swimming, Tai Chi.
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 |
|---|---|---|
| individual physical exercise groupThe participants in physical exercise group will receiving individual physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks. | Behavioural | Individual physical exercise group |
| individual Branched-Chain Amino Acids supplements groupThe participants in nutrition supplements group will receiving Branched-Chain Amino Acids 5 g Branched-Chain Amino Acids every day for 12 weeks. | Dietary supplement | Individual Branched-Chain Amino Acids supplements group |
| combination of physical exercise and nutrition supplements groupThe participants in physical exercise group will receiving physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks and 5 g Branched-Chain Amino Acids every day for 12 weeks. | Other | Combination of physical exercise and Branched-Chain Amino Acids supplements group |
Primary outcome
frailty score
Time frame: frailty score at baseline
Frailty will examined using Fried's phenotype method and higher score indicates more frailty
frailty score
Time frame: through study completion, an average of 12 weeks
Frailty will examined using Fried's phenotype method and higher score indicates more frailty
4 secondary outcomes
Depressive symptoms score
Time frame: Depressive symptoms at baseline
Depressive symptoms score
Time frame: through study completion, an average of 12 weeks
Quality of Life score
Time frame: Quality of Life at baseline
Quality of Life score
Time frame: through study completion, an average of 12 weeks
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 23 Mar 2022.
- Derived from this study: PubMed 37018848Chen LF, Chang HC, Cai ZC, Chen YJ, Hsu WL, Chuang YH, Lee SC, Huang HC. Community-based exercise and nutritional interventions to improve frailty syndrome among older adults: A quasi-experimental study. Geriatr Nurs. 2023 May-Jun;51:222-231. doi: 10.1016/j.gerinurse.2023.03.016. Epub 2023 Apr 3.
- Individual participant dataSharing planned: No
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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.
Hui-Chuan Huang, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual physical exercise group, individual Branched-Chain Amino Acids supplements group and combination of physical exercise and nutrition supplements group in people with Sarcopenia and Physical Exercise, run by Taipei Medical University 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 4 inclusion and 4 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 23 Mar 2022. 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?
frailty score (time frame: frailty score at baseline). The study lists 2 primary outcomes in all. 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 NCT04777279, 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 23 Mar 2022.