- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04311138
Effect of Community-based Reablement
March 14, 2020 updated by: CY Song
The Effect of Community-based Reablement in Remote Areas
This study aims o investigate the effect of a diversified community-based reablement on motor function, cognitive function, performance in activities of daily living (ADL), and physical performance of older people living in remote areas.
Older adults who are mobile but unstable were recruited from 6 public elderly day care centers in remote areas of the New Taipei City.
Experimental group received a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour, while control group received 1.5-hr group intervention and 1.0-hr placebo intervention.
The de Morton Mobility Index (DEMMI), Saint Louis Mental Status Examination (SLUMS), Barthel Index (BI), Canadian Occupational Performance Measure (COPM), and the Short Physical Performance Battery (SPPB) including balance, gait speed, chair stand tests were evaluated twice before and after interventions.
The results of the current study are expected to provide evidence in supporting a novel and diversified community-based reablement in remote areas.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
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
-
-
-
Taipei, Taiwan, 11219
- National Taipei University of Nursing and Health Sciences
-
-
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
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- living in community and participating in public elderly day care centers in remote areas of the New Taipei City
- speaking with Chinese or Taiwanese
- DEMMI score of 39-67
Exclusion Criteria:
- diagnosed with moderate or severe cognitive impairment (CDR score of 2 or above)
- unable to understand or follow one step instruction
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental group
Experimental group receive a 10-wk diversified community-based reablement service.
|
Experimental group receive a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour.
|
ACTIVE_COMPARATOR: Control group
Control group receive a 10-wk multicomponent training.
|
control group receive a 10-wk multicomponent training including 1.5-hr group intervention (group exercise, cognitive training, and health education) and 1.0-hr placebo intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mobility function
Time Frame: baseline and 10 weeks
|
de Morton Mobility Index (DEMMI)
|
baseline and 10 weeks
|
Change in cognitive function
Time Frame: baseline and 10 weeks
|
Saint Louis Mental Status Examination (SLUMS)
|
baseline and 10 weeks
|
Change in performance in activities of daily living
Time Frame: baseline and 10 weeks
|
Barthel Index (BI)
|
baseline and 10 weeks
|
Change in occupational performance
Time Frame: baseline and 10 weeks
|
Canadian Occupational Performance Measure (COPM)
|
baseline and 10 weeks
|
Change in physical performance
Time Frame: baseline and 10 weeks
|
Short Physical Performance Battery (SPPB)
|
baseline and 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ChenYi Song, National Taipei University of Nursing and Health Sciences
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 3, 2019
Primary Completion (ACTUAL)
November 29, 2019
Study Completion (ACTUAL)
November 29, 2019
Study Registration Dates
First Submitted
March 12, 2020
First Submitted That Met QC Criteria
March 14, 2020
First Posted (ACTUAL)
March 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 14, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19-060-B
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.
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