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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04311138
Other study ID # 19-060-B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2019
Est. completion date November 29, 2019

Study information

Verified date March 2020
Source National Taipei University of Nursing and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date November 29, 2019
Est. primary completion date November 29, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
Taiwan National Taipei University of Nursing and Health Sciences Taipei

Sponsors (1)

Lead Sponsor Collaborator
CY Song

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mobility function de Morton Mobility Index (DEMMI) baseline and 10 weeks
Primary Change in cognitive function Saint Louis Mental Status Examination (SLUMS) baseline and 10 weeks
Primary Change in performance in activities of daily living Barthel Index (BI) baseline and 10 weeks
Primary Change in occupational performance Canadian Occupational Performance Measure (COPM) baseline and 10 weeks
Primary Change in physical performance Short Physical Performance Battery (SPPB) baseline and 10 weeks
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