Exercise InterventionNCT06096467
The Impact of Exercise Intervention on Physical Function Falls, and Physical Restraint for Long-term Care Residents
A study testing Comprehension Exercise Training and Protein Supplement in people with Exercise Intervention and Protein Supplementation, run by Cardinal Tien Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to test the effect of the Cross-disciplinary Teamwork Care Model and Exercise Intervention in residents living in long-term care institutions. The main question[s] it aims to answer are: Increased physical performance. Reduced the physical restraint. Reduced fall accidents. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Exercise Intervention, Protein Supplementation
- What is being tested?
- Comprehension Exercise Training and Protein Supplement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age is 65 years or older
- Placement is greater than or equal to 6 months
- Less dependency in activities of daily life (ADL) function50 (severe to moderate dependency, Barthel index: 21 ≤ score ≤ 90)
- Able to understand the exercise instructions and follow the order.
Who cannot join
- Skeletomuscular (severe osteoarthritis (OA) or recent or mal- or non-union fracture, etc.) or cardiopulmonary diseases (COVID-19 or unstable angina or controlled hypertension, etc.) that are unstable and pose a threat to safety
- Mental disorders that prevent the subject from following instructions (severe mental disorder, Short Portable Mental State Questionnaire (SPMSQ): 8 ≤ score ≤ 10).
- Protein supplementations are contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Cross-disciplinary Teamwork Care Model and Exercise Intervention on Physical Function Falls, and Physical Restraint for Residents in Long-term Care Institution
The goal of this clinical trial is to test the effect of the Cross-disciplinary Teamwork Care Model and Exercise Intervention in residents living in long-term care institutions. The main question[s] it aims to answer are:
- Increased physical performance.
- Reduced the physical restraint.
- Reduced fall accidents.
Participants will accept the comprehension Exercise Intervention combined with protein supplementation or not.
Read the detailed description
The prevalence of institutional physical restraint, both at home and abroad, remains alarmingly high. The Health Care Financing Administration (HCFA) in 1999 provided a comprehensive definition for physical restraint in nursing homes, encompassing any manual, physical, or mechanically related device, material, or tool attached to or installed on a resident's body that hinders their freedom of movement or contact with their body. The primary objective of implementing physical restraint in healthcare settings is to prevent patients from becoming agitated, safeguard them from self-inflicted injuries, protect the staff, prevent falls, and manage routine care and behavior control. Unfortunately, falls are a common occurrence among the elderly, whether they are living at home or in institutional settings.
Falls in the elderly are often attributed to a myriad of factors, including poor physical function and the use of multiple medications. Impaired physical function components such as diminished muscle strength, imbalanced balance abilities, delayed reaction times, postural hypotension, and cognitive dysfunction are frequently observed contributors to falls. Furthermore, malnutrition or undernutrition is a prevalent concern among the elderly, affecting those being cared for at home or placed in institutional settings. Malnutrition compounds the adverse effects on physical function, leading to muscular weakness and potentially the development of sarcopenia, a condition characterized by a loss of muscle mass and strength. This not only compromises immunity but also elevates the risk of disease and increases the likelihood of disability or falls among the elderly.
In response to these challenges, this study aims to be conducted collaboratively by the three private nursing type centers (Guang-nenn Care Center for the Elderly, Tung-shin Long-term Care Center, and the Hu-An Long-term Care Center for the Elderly). The study will involve 22 elderly patients. The primary objective is to address the multifaceted issues of physical restraint, falls, and declining physical function in elderly care facilities.
The research team began by conducting a systematic review of the existing literature on long-term care institutions, interdisciplinary teamwork care models, sports interventions, physical function, falls, and physical restraint. This comprehensive review served as the foundation for designing a 12-month "comprehensive multi-component exercise" program. The program is based on evidence from the literature and aims to enhance the strength, balance, and mobility of residents through carefully tailored exercise interventions.
The ultimate goal of the exercise program is to reduce the utilization of physical restraint as a means to prevent falls. By focusing on improving residents' physical abilities, the research anticipates a decrease in the need for physical restraint, ultimately enhancing the quality of life for elderly individuals in these long-term care facilities.
- Conditions
- Exercise Intervention, Protein Supplementation
- Being tested
- Comprehension Exercise Training, Placebo milk, Protein Supplement
- Keywords
- protein supplementation, exercise, long-term care institutions
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehension Exercise TrainingBehavioural
Also called CET
Comprehension exercise: 45~50 minutes exercise for each session(warm-up, resistive, functional activities and balance exercise, and cool-down)
Placebo milkDietary supplement
Also called PC
Placebo milk: 8 g. protein for each serving and provided immediately after the CET session
Protein SupplementDietary supplement
Also called PS
Protein Supplement: 40 g. whey protein for each serving and provided immediately after the CET session
| Study group | Role | What they receive |
|---|---|---|
| Comprehension exercise training combined with protein supplementation (CET+PS) | Experimental | CET+PS: the comprehension exercise training combined with protein supplementation Receives: Behavioral: Comprehension Exercise Training; Dietary Supplement: Protein Supplement |
| Comprehension exercise training combined with placebo milk (CET+PC) | Placebo comparator | CET+PC: the comprehension exercise training combined with placebo milk Receives: Behavioral: Comprehension Exercise Training; Dietary Supplement: Placebo milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
To evaluate the physical functional performance of elderly individuals.The assessment primarily comprises three components: standing balance, mobility (four-meter walk test), and muscle strength (five-repetition sit-to-stand test).
Measured: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T2: immediately after Phase 2 intervention, and completed the assessments within 1 week.
Secondary outcomes (4)
Muscle strength of Upper limb and lower limb
Test the strength of hand grip and knee extension.
Measured: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.
Functional forward reach (FFR)
The Functional Forward Reach Test is used to assess subjects' standing balance.
Measured: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.
Number of fall occurrences
Read records from nursing care daily record the institutions.
Measured: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.
Number of physical restraint occurrence
Read records from nursing care daily record of the institutions.
Measured: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
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 Exercise InterventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardinal Tien Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsai Ren Jei, MS, Cardinal Tien Hospital
- Investigators
- Senyeong Kao, Ph.D, Study chair, National Defense Medical Center, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096467
- Sponsor's protocol ID
- TSGHIRB SOP AF03-05.4/D6.0
- Status last verified
- Feb 2024
- First submitted
- 18 Oct 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao CD, Lee PH, Hsiao DJ, Huang SW, Tsauo JY, Chen HC, Liou TH. Effects of Protein Supplementation Combined with Exercise Intervention on Frailty Indices, Body Composition, and Physical Function in Frail Older Adults. Nutrients. 2018 Dec 4;10(12):1916. doi: 10.3390/nu10121916.
PubMed 30518122Carlsson M, Littbrand H, Gustafson Y, Lundin-Olsson L, Lindelof N, Rosendahl E, Haglin L. Effects of high-intensity exercise and protein supplement on muscle mass in ADL dependent older people with and without malnutrition: a randomized controlled trial. J Nutr Health Aging. 2011 Aug;15(7):554-60. doi: 10.1007/s12603-011-0017-5.
PubMed 21808934
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cross-disciplinary Teamwork Care Model and Exercise Intervention on Physical Function Falls, and Physical Restraint for Residents in Long-term Care Institution
- ClinicalTrials.gov ID
- NCT06096467
- Acronym / sponsor ID
- TSGHIRB SOP AF03-05.4/D6.0
- Conditions
- Exercise Intervention, Protein Supplementation
- Keywords
- protein supplementation, exercise, long-term care institutions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cardinal Tien HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 23 Oct 2023 (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.
The goal of this clinical trial is to test the effect of the Cross-disciplinary Teamwork Care Model and Exercise Intervention in residents living in long-term care institutions. The main question[s] it aims to answer are:
- Increased physical performance.
- Reduced the physical restraint.
- Reduced fall accidents.
Participants will accept the comprehension Exercise Intervention combined with protein supplementation or not.
Detailed description
The prevalence of institutional physical restraint, both at home and abroad, remains alarmingly high. The Health Care Financing Administration (HCFA) in 1999 provided a comprehensive definition for physical restraint in nursing homes, encompassing any manual, physical, or mechanically related device, material, or tool attached to or installed on a resident's body that hinders their freedom of movement or contact with their body. The primary objective of implementing physical restraint in healthcare settings is to prevent patients from becoming agitated, safeguard them from self-inflicted injuries, protect the staff, prevent falls, and manage routine care and behavior control. Unfortunately, falls are a common occurrence among the elderly, whether they are living at home or in institutional settings.
Falls in the elderly are often attributed to a myriad of factors, including poor physical function and the use of multiple medications. Impaired physical function components such as diminished muscle strength, imbalanced balance abilities, delayed reaction times, postural hypotension, and cognitive dysfunction are frequently observed contributors to falls. Furthermore, malnutrition or undernutrition is a prevalent concern among the elderly, affecting those being cared for at home or placed in institutional settings. Malnutrition compounds the adverse effects on physical function, leading to muscular weakness and potentially the development of sarcopenia, a condition characterized by a loss of muscle mass and strength. This not only compromises immunity but also elevates the risk of disease and increases the likelihood of disability or falls among the elderly.
In response to these challenges, this study aims to be conducted collaboratively by the three private nursing type centers (Guang-nenn Care Center for the Elderly, Tung-shin Long-term Care Center, and the Hu-An Long-term Care Center for the Elderly). The study will involve 22 elderly patients. The primary objective is to address the multifaceted issues of physical restraint, falls, and declining physical function in elderly care facilities.
The research team began by conducting a systematic review of the existing literature on long-term care institutions, interdisciplinary teamwork care models, sports interventions, physical function, falls, and physical restraint. This comprehensive review served as the foundation for designing a 12-month "comprehensive multi-component exercise" program. The program is based on evidence from the literature and aims to enhance the strength, balance, and mobility of residents through carefully tailored exercise interventions.
The ultimate goal of the exercise program is to reduce the utilization of physical restraint as a means to prevent falls. By focusing on improving residents' physical abilities, the research anticipates a decrease in the need for physical restraint, ultimately enhancing the quality of life for elderly individuals in these long-term care facilities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehension exercise training combined with protein supplementation (CET+PS) | Experimental | Behavioral: Comprehension Exercise Training, Dietary Supplement: Protein SupplementCET+PS: the comprehension exercise training combined with protein supplementation |
| Comprehension exercise training combined with placebo milk (CET+PC) | Placebo comparator | Behavioral: Comprehension Exercise Training, Dietary Supplement: Placebo milkCET+PC: the comprehension exercise training combined with placebo milk |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age is 65 years or older
- Placement is greater than or equal to 6 months
- Less dependency in activities of daily life (ADL) function50 (severe to moderate dependency, Barthel index: 21 ≤ score ≤ 90)
- Able to understand the exercise instructions and follow the order.
Key exclusion criteria (3 listed)
- Skeletomuscular (severe osteoarthritis (OA) or recent or mal- or non-union fracture, etc.) or cardiopulmonary diseases (COVID-19 or unstable angina or controlled hypertension, etc.) that are unstable and pose a threat to safety
- Mental disorders that prevent the subject from following instructions (severe mental disorder, Short Portable Mental State Questionnaire (SPMSQ): 8 ≤ score ≤ 10).
- Protein supplementations are contraindicated.
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 |
|---|---|---|
| Comprehension Exercise TrainingAlso: CETComprehension exercise: 45~50 minutes exercise for each session(warm-up, resistive, functional activities and balance exercise, and cool-down) | Behavioural | Comprehension exercise training combined with placebo milk (CET+PC), Comprehension exercise training combined with protein supplementation (CET+PS) |
| Placebo milkAlso: PCPlacebo milk: 8 g. protein for each serving and provided immediately after the CET session | Dietary supplement | Comprehension exercise training combined with placebo milk (CET+PC) |
| Protein SupplementAlso: PSProtein Supplement: 40 g. whey protein for each serving and provided immediately after the CET session | Dietary supplement | Comprehension exercise training combined with protein supplementation (CET+PS) |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T2: immediately after Phase 2 intervention, and completed the assessments within 1 week.
To evaluate the physical functional performance of elderly individuals.The assessment primarily comprises three components: standing balance, mobility (four-meter walk test), and muscle strength (five-repetition sit-to-stand test).
4 secondary outcomes
Muscle strength of Upper limb and lower limb
Time frame: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.
Functional forward reach (FFR)
Time frame: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.
Number of fall occurrences
Time frame: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.
Number of physical restraint occurrence
Time frame: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.
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 7 Feb 2024.
- Results publication: PubMed 30518122Liao CD, Lee PH, Hsiao DJ, Huang SW, Tsauo JY, Chen HC, Liou TH. Effects of Protein Supplementation Combined with Exercise Intervention on Frailty Indices, Body Composition, and Physical Function in Frail Older Adults. Nutrients. 2018 Dec 4;10(12):1916. doi: 10.3390/nu10121916.
- Results publication: PubMed 21808934Carlsson M, Littbrand H, Gustafson Y, Lundin-Olsson L, Lindelof N, Rosendahl E, Haglin L. Effects of high-intensity exercise and protein supplement on muscle mass in ADL dependent older people with and without malnutrition: a randomized controlled trial. J Nutr Health Aging. 2011 Aug;15(7):554-60. doi: 10.1007/s12603-011-0017-5.
- 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.
Senyeong Kao, Ph.D study chair
National Defense Medical Center, School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehension Exercise Training and Protein Supplement in people with Exercise Intervention and Protein Supplementation, run by Cardinal Tien 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 4 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 7 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
Short Physical Performance Battery (SPPB) (time frame: T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T2: immediately after Phase 2 intervention, and completed the assessments within 1 week.). 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 NCT06096467, 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 7 Feb 2024.