NCT04812587

Brief Summary

This study aimed to determine whether a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability was designed to improve functional fitness, balance, walking speed in community-dwelling older people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 12, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

April 13, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

March 8, 2021

Last Update Submit

April 8, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes in performance of Physical fitness at 12-week

    Senior Fitness test (30-second Chair Stand, 30-second Arm Curl, 2-minute Step, Chair Sit and Reach and 8 Foot Up-and-Go)

    The assessments will be conducted before, immediately after intervention for the experimental group; two times of these assessments to be at an interval of 12 weeks are conducted for the comparison group

  • Changes in Balance and walking ability at 12-week

    One leg standing, Five-repetition sit-to-stand test, Timed up-and-go test and Walking speed test

    The assessments will be conducted before, immediately after intervention for the experimental group; two times of these assessments to be at an interval of 12 weeks are conducted for the comparison group

Study Arms (2)

Experimental group

EXPERIMENTAL

The healthy elderly will be were recruited to participate in this study. All the subjects were independent in basic daily living activities, but at least one or more given assistance in the instrumental IADL assessment (ability to use telephone, shopping, food preparing, housekeeping, laundry, mode of transportation, responsibility for own medications, ability to handle finances). Their age should be ranged between 65 - 81 years.

Behavioral: exercise intervention program

Comparison group

NO INTERVENTION

The healthy elderly will be were recruited to participate in this study. All the subjects were independent in basic daily living activities, but at least one or more given assistance in the instrumental IADL assessment (ability to use telephone, shopping, food preparing, housekeeping, laundry, mode of transportation, responsibility for own medications, ability to handle finances). Their age should be ranged between 65 - 81 years.

Interventions

The experimental group will receive a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability which involved two 2-hour sessions once per week.

Experimental group

Eligibility Criteria

Age65 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Independent in basic daily living activities
  • At least one or more given assistance in the instrumental Instrumental Activities of Daily Living (IADL) scale

You may not qualify if:

  • Diagnosis of neurological disease or heart disease
  • Assessment do not suitable resistance exercise training, or cannot perform intense activity by doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Li-Jiun Liaw

Kaohsiung City, Sanmin Dist, 80708, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Li-Jiun Liaw

    Kaohsiung Medical University Department of Physical Therapy Associate Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 23, 2021

Study Start

January 12, 2018

Primary Completion

September 6, 2019

Study Completion

September 6, 2019

Last Updated

April 13, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Currently in the submission stage ,and then share with other researchers after publication

Locations