NCT05021848

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

August 19, 2021

Last Update Submit

April 6, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change of activities of daily living function

    Barthel Index (BI)

    before , after 12-weeks interventions

  • Change of physical function

    Short Physical Performance Battery (SPPB)

    before , after 12-weeks interventions

  • Change of mobility

    de Morton Mobility Index(DEMMI)

    before , after 12-weeks interventions

  • Change of grip strength

    Handgrip strength

    before , after 12-weeks interventions

  • Change of sense of well-being

    Chinese Happiness Inventory (CHI)

    before , after 12-weeks interventions

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group (N=14) received a 90-minute partnered multicomponent exercises intervention once weekly for 12 weeks

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)

Interventions

aerobic,strength, flexibility and balance exercises and game

Experimental group

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 60years old,living in the long term care facilities,after Physician agrees.No infectious diseases.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 11219, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Chen-Yi Song

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 26, 2021

Study Start

September 2, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations