NCT03668886

Brief Summary

The number of elderly has been increasing in recent decades. Current studies focused on the risk factors of poor physical performance, poor daily activity performance, and even disability in the elderly. We planned to evaluate the physical performance of elderly dwelling in the community and designed a multimodal exercise program which can improve physical performance, prevent disability and promote quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

August 29, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

August 29, 2018

Last Update Submit

August 5, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Gait speed

    measure gait speed as usual

    change between two time points (baseline, 3 months later)

  • Gait speed

    measure gait speed as usual

    change between two time points (baseline, 6 months later)

Secondary Outcomes (23)

  • Muscle mass

    change between two time points (baseline, 6 months later)

  • Level (mild, moderate, maximal) of daily activity

    change between two time points (baseline, 3 months later)

  • Level (mild, moderate, maximal) of daily activity

    change between two time points (baseline, 6 months later)

  • Zipper test

    change between two time points (baseline, 3 months later)

  • Zipper test

    change between two time points (baseline, 6 months later)

  • +18 more secondary outcomes

Study Arms (2)

multimodal exercise program

EXPERIMENTAL

Elderly in this group will receive multimodal exercise program. The duration of exercise is 60 minutes and frequency is 2 times/week.

Other: multimodal exercise program

Control group

NO INTERVENTION

Elderly in this group will continue to attend community activity as usual. The activity includes active activity is 60 minutes and frequency is 2 times/week.

Interventions

warm-up, strengthening exercise, aerobic exercise, cool-down

multimodal exercise program

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • \>= 65 year old

You may not qualify if:

  • cognitive impairment and poor understanding for orders
  • the elderly has medical problems that the elderly can't perform exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yu Hsuan Tseng

Kaohsiung City, Taiwan

Location

Study Officials

  • Shui Tseng

    Chang Gung Medical Foundation Institutional Review Board

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: intervention group: receive multimodal exercise program for half year control group: participate community activity
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 13, 2018

Study Start

September 1, 2018

Primary Completion

June 30, 2019

Study Completion

July 31, 2019

Last Updated

August 6, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations