- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05021848
Partnered Multicomponent Exercise for Elderly in Long-term Care Facilities
April 6, 2022 updated by: CY Song, National Taipei University of Nursing and Health Sciences
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).
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 11219
- National Taipei University of Nursing and Health Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 60years old,living in the long term care facilities,after Physician agrees.No infectious diseases.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
The experimental group (N=14) received a 90-minute partnered multicomponent exercises intervention once weekly for 12 weeks
|
aerobic,strength, flexibility and balance exercises and game
|
|
No Intervention: control group
The control group (N=14) carried out the usual activities without intervention.
(After 12-wk, multicomponent exercises intervention will be given)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of activities of daily living function
Time Frame: before , after 12-weeks interventions
|
Barthel Index (BI)
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before , after 12-weeks interventions
|
|
Change of physical function
Time Frame: before , after 12-weeks interventions
|
Short Physical Performance Battery (SPPB)
|
before , after 12-weeks interventions
|
|
Change of mobility
Time Frame: before , after 12-weeks interventions
|
de Morton Mobility Index(DEMMI)
|
before , after 12-weeks interventions
|
|
Change of grip strength
Time Frame: before , after 12-weeks interventions
|
Handgrip strength
|
before , after 12-weeks interventions
|
|
Change of sense of well-being
Time Frame: before , after 12-weeks interventions
|
Chinese Happiness Inventory (CHI)
|
before , after 12-weeks interventions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2021
Primary Completion (Actual)
January 31, 2022
Study Completion (Actual)
January 31, 2022
Study Registration Dates
First Submitted
August 19, 2021
First Submitted That Met QC Criteria
August 19, 2021
First Posted (Actual)
August 26, 2021
Study Record Updates
Last Update Posted (Actual)
April 7, 2022
Last Update Submitted That Met QC Criteria
April 6, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 21-046-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.