ExerciseNCT05021848
Partnered Multicomponent Exercise for Elderly in Long-term Care Facilities
A study testing partnered multicomponent exercises program in people with Exercise and Long Term Care Facilities, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
This study aimed to explore the effects of a partnered multicomponent exercise program on improving the physical function and sense of well-being of elderly people in Long-term Care Facilities (LTCFs). Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Long Term Care Facilities, Physical Function
- What is being tested?
- partnered multicomponent exercises program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Sep 2021to 31 Jan 2022
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 60years old,living in the long term care facilities,after Physician agrees.No infectious diseases.
Who cannot join
- Acute disease or unstable state (such as heart failure).
- Severe musculoskeletal diseases (such as fractures, lower limb joint pain and deformation).
- Cognitive impairment (MMSE<20) .
- At the end of life.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences
Taipei, 11219
About this study
Official title: Effects of a Partnered Multicomponent Exercise Program on Improving the Physical Function and Well-being of Elderly People in Long-term Care Facilities
This study aimed to explore the effects of a partnered multicomponent exercise program on improving the physical function and sense of well-being of elderly people in Long-term Care Facilities (LTCFs).
Read the detailed description
This study is a single-blinded randomized controlled trial. Elderly residents were recruited from two LTCFs in Yilan county. The experimental group (N=14) received a 90-minute partnered multicomponent exercises intervention once weekly for 12 weeks. The control group (N=14) carried out the usual activities without intervention. The Barthel Index (BI), Short Physical Performance Battery (SPPB), De Morton Mobility Index(DEMMI), handgrip strength, and Chinese Happiness Inventory (CHI) were measured before and after the interventions.
- Conditions
- Exercise, Long Term Care Facilities, Physical Function, Happiness
- Being tested
- partnered multicomponent exercises program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partnered multicomponent exercises programOther
aerobic,strength, flexibility and balance exercises and game
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group (N=14) received a 90-minute partnered multicomponent exercises intervention once weekly for 12 weeks Receives: Other: partnered multicomponent exercises program |
| control group | No intervention | The control group (N=14) carried out the usual activities without intervention. (After 12-wk, multicomponent exercises intervention will be given) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of activities of daily living function
Barthel Index (BI)
Measured: before , after 12-weeks interventions
Change of physical function
Short Physical Performance Battery (SPPB)
Measured: before , after 12-weeks interventions
Change of mobility
de Morton Mobility Index(DEMMI)
Measured: before , after 12-weeks interventions
Change of grip strength
Handgrip strength
Measured: before , after 12-weeks interventions
Change of sense of well-being
Chinese Happiness Inventory (CHI)
Measured: before , after 12-weeks interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start2 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CY Song, National Taipei University of Nursing and Health Sciences
- Investigators
- Chen-Yi Song, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021848
- Sponsor's protocol ID
- 21-046-B
- Status last verified
- Apr 2022
- First submitted
- 19 Aug 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Partnered Multicomponent Exercise Program on Improving the Physical Function and Well-being of Elderly People in Long-term Care Facilities
- ClinicalTrials.gov ID
- NCT05021848
- Acronym / sponsor ID
- 21-046-B
- Conditions
- Exercise, Long Term Care Facilities, Physical Function, Happiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 26 Aug 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 aimed to explore the effects of a partnered multicomponent exercise program on improving the physical function and sense of well-being of elderly people in Long-term Care Facilities (LTCFs).
Detailed description
This study is a single-blinded randomized controlled trial. Elderly residents were recruited from two LTCFs in Yilan county. The experimental group (N=14) received a 90-minute partnered multicomponent exercises intervention once weekly for 12 weeks. The control group (N=14) carried out the usual activities without intervention. The Barthel Index (BI), Short Physical Performance Battery (SPPB), De Morton Mobility Index(DEMMI), handgrip strength, and Chinese Happiness Inventory (CHI) were measured before and after the interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: partnered multicomponent exercises programThe experimental group (N=14) received a 90-minute partnered multicomponent exercises intervention once weekly for 12 weeks |
| control group | No intervention | –The control group (N=14) carried out the usual activities without intervention. (After 12-wk, multicomponent exercises intervention will be given) |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 60years old,living in the long term care facilities,after Physician agrees.No infectious diseases.
Key exclusion criteria (4 listed)
- Acute disease or unstable state (such as heart failure).
- Severe musculoskeletal diseases (such as fractures, lower limb joint pain and deformation).
- Cognitive impairment (MMSE<20) .
- At the end of life.
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 |
|---|---|---|
| partnered multicomponent exercises programaerobic,strength, flexibility and balance exercises and game | Other | Experimental group |
Primary outcome
Change of activities of daily living function
Time frame: before , after 12-weeks interventions
Barthel Index (BI)
Change of physical function
Time frame: before , after 12-weeks interventions
Short Physical Performance Battery (SPPB)
Change of mobility
Time frame: before , after 12-weeks interventions
de Morton Mobility Index(DEMMI)
Change of grip strength
Time frame: before , after 12-weeks interventions
Handgrip strength
Change of sense of well-being
Time frame: before , after 12-weeks interventions
Chinese Happiness Inventory (CHI)
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 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Chen-Yi Song principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partnered multicomponent exercises program in people with Exercise and Long Term Care Facilities, run by National Taipei University of Nursing and Health Sciences 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 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 7 Apr 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?
Change of activities of daily living function (time frame: before , after 12-weeks interventions). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2022.