SarcopeniaNCT02912338
The Effectiveness of Lifestyle Intervention on Body Composition, Physical Performances and Quality of Life Among Elderly People in Long-term Care Facilities
A study testing Resistant Training in people with Sarcopenia and Obesity, run by Central Taiwan University of Science and Technology.
Trial summary
Purpose: To understand the change in body composition, physical functions and quality of life of elderly residents with sarcopenic obesity in LTC facilities after the implementation of exercise intervention. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia, Obesity
- What is being tested?
- Resistant Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Mar 2016
- 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
- aged and elderly over 60 years old and no exercise restrictions.
- conscious clear, able to communicate with to the traditional Chinese language or Taiwanese.
- in the past three months living in long-term care institutions.
- in the last month the subject biased static life
- in a stable condition with enough energy: to maintain the support of at least one hour sitting in a wheelchair or bed edge.
Who cannot join
- In the past three months have unstable weight (> ± 4 kg).
- severe disease states, such as severe heart and lung liver and kidney disease, a serious cancer, severe malnutrition (Mini Nutritional Assessment Scale 0-7 points).
- limb unable to anti-gravity completely
- severe dementia (Clinical Dementia Rating (CDR) Scale Clinical Dementia Rating, CDR 3-5 points).
About this study
Purpose: To understand the change in body composition, physical functions and quality of life of elderly residents with sarcopenic obesity in LTC facilities after the implementation of exercise intervention.
- Conditions
- Sarcopenia, Obesity
- Being tested
- Resistant Training, Control Group
- Keywords
- Sarcopenic obesity, Body composition, Physical function, quality of life, long term care
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant TrainingBehavioural
Control GroupOther
| Study group | Role | What they receive |
|---|---|---|
| Resistant Training Group | Experimental | sandbag 2-5lb, grip ball, twice/week, Duration:12 weeks Receives: Behavioral: Resistant Training |
| Control Group | Active comparator | not change lifestyle Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
measuring machine: Bioelectrical impedance analysis (BIA) estimates body composition of fat and lean tissue.
Measured: Change gram, kg and percentage from baseline to follow up (12 weeks later)
body weight
Weighing scales in kilograms
Measured: Change kg from baseline to follow up (12 weeks later)
BMI
kg/m2
Measured: Change from baseline to follow up (12 weeks later)
hand grip
Jamar Handgrip Dynamometer
Measured: Change from baseline to follow up (12 weeks later)
hand pinch
Lafayette Hydraulic Pinch Gauge 5030P1
Measured: Change kg from baseline to follow up (12 weeks later)
Activities of daily living
Functional Independence Measure (FIM) included 18 items, covering 6 situations in the burden of personal care, specifically self-care, mobility, transfers, sphincter management, communication, and social cognition. A high score indicates better function.
Measured: Change score from baseline to follow up (12 weeks later)
Quality of Life
Short Form 8 health survey (SF8)included the items focusing on physical and mental health; EuroQol-5D (EQ-5D) includes the EQ-visual analogue scale (VAS) and the EQ-5D descriptive system. EQ-VAS documents the participant's self-reported health on a VAS of 100-0. The EQ-5D-3L descriptive system consists of five dimensions, namely mobility, self-care, usual activities, pain/discomfort and anxiety/depression, all with three function levels (no problem = 1; some problems = 2; severe problems = 3)
Measured: Change score from baseline to follow up (12 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Taiwan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiu Shu-Ching, Central Taiwan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912338
- Sponsor's protocol ID
- CTU104-PC-014
- Status last verified
- Jul 2019
- First submitted
- 9 Sep 2016
- Last updated
- 22 Jul 2019
- Results posted
- No
Publications
Chang SF, Chiu SC. Effect of resistance training on quality of life in older people with sarcopenic obesity living in long-term care institutions: A quasi-experimental study. J Clin Nurs. 2020 Jul;29(13-14):2544-2556. doi: 10.1111/jocn.15277. Epub 2020 Apr 24.
PubMed 32279360Chiu SC, Yang RS, Yang RJ, Chang SF. Effects of resistance training on body composition and functional capacity among sarcopenic obese residents in long-term care facilities: a preliminary study. BMC Geriatr. 2018 Jan 22;18(1):21. doi: 10.1186/s12877-018-0714-6.
PubMed 29357826
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Lifestyle Intervention on Body Composition, Physical Performances and Quality of Life Among Elderly People in Long-term Care Facilities
- ClinicalTrials.gov ID
- NCT02912338
- Acronym / sponsor ID
- CTU104-PC-014
- Conditions
- Sarcopenia, Obesity
- Keywords
- Sarcopenic obesity, Body composition, Physical function, quality of life, long term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Central Taiwan University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Sep 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.
Purpose: To understand the change in body composition, physical functions and quality of life of elderly residents with sarcopenic obesity in LTC facilities after the implementation of exercise intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant Training Group | Experimental | Behavioral: Resistant Trainingsandbag 2-5lb, grip ball, twice/week, Duration:12 weeks |
| Control Group | Active comparator | Other: Control Groupnot change lifestyle |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged and elderly over 60 years old and no exercise restrictions.
- conscious clear, able to communicate with to the traditional Chinese language or Taiwanese.
- in the past three months living in long-term care institutions.
- in the last month the subject biased static life
- in a stable condition with enough energy: to maintain the support of at least one hour sitting in a wheelchair or bed edge.
Key exclusion criteria (4 listed)
- In the past three months have unstable weight (> ± 4 kg).
- severe disease states, such as severe heart and lung liver and kidney disease, a serious cancer, severe malnutrition (Mini Nutritional Assessment Scale 0-7 points).
- limb unable to anti-gravity completely
- severe dementia (Clinical Dementia Rating (CDR) Scale Clinical Dementia Rating, CDR 3-5 points).
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 |
|---|---|---|
| Resistant Training | Behavioural | Resistant Training Group |
| Control Group | Other | Control Group |
Primary outcome
Body Composition
Time frame: Change gram, kg and percentage from baseline to follow up (12 weeks later)
measuring machine: Bioelectrical impedance analysis (BIA) estimates body composition of fat and lean tissue.
body weight
Time frame: Change kg from baseline to follow up (12 weeks later)
Weighing scales in kilograms
BMI
Time frame: Change from baseline to follow up (12 weeks later)
kg/m2
hand grip
Time frame: Change from baseline to follow up (12 weeks later)
Jamar Handgrip Dynamometer
hand pinch
Time frame: Change kg from baseline to follow up (12 weeks later)
Lafayette Hydraulic Pinch Gauge 5030P1
Activities of daily living
Time frame: Change score from baseline to follow up (12 weeks later)
Functional Independence Measure (FIM) included 18 items, covering 6 situations in the burden of personal care, specifically self-care, mobility, transfers, sphincter management, communication, and social cognition. A high score indicates better function.
Quality of Life
Time frame: Change score from baseline to follow up (12 weeks later)
Short Form 8 health survey (SF8)included the items focusing on physical and mental health; EuroQol-5D (EQ-5D) includes the EQ-visual analogue scale (VAS) and the EQ-5D descriptive system. EQ-VAS documents the participant's self-reported health on a VAS of 100-0. The EQ-5D-3L descriptive system consists of five dimensions, namely mobility, self-care, usual activities, pain/discomfort and anxiety/depression, all with three function levels (no problem = 1; some problems = 2; severe problems = 3)
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 22 Jul 2019.
- Derived from this study: PubMed 32279360Chang SF, Chiu SC. Effect of resistance training on quality of life in older people with sarcopenic obesity living in long-term care institutions: A quasi-experimental study. J Clin Nurs. 2020 Jul;29(13-14):2544-2556. doi: 10.1111/jocn.15277. Epub 2020 Apr 24.
- Derived from this study: PubMed 29357826Chiu SC, Yang RS, Yang RJ, Chang SF. Effects of resistance training on body composition and functional capacity among sarcopenic obese residents in long-term care facilities: a preliminary study. BMC Geriatr. 2018 Jan 22;18(1):21. doi: 10.1186/s12877-018-0714-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Training in people with Sarcopenia and Obesity, run by Central Taiwan University of Science and Technology.
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 5 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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Body Composition (time frame: Change gram, kg and percentage from baseline to follow up (12 weeks later)). The study lists 7 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 NCT02912338, which also lists 2 linked publications.
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 22 Jul 2019.