NCT04137939

Brief Summary

Subjects are divided into two groups, (1) Control (Ctrl) and (2) Smart Exercise (SE) group. Ctrl group are instructed to maintain their daily life. SE participants are instructed to do exercise with smart exercise system twice per week for 12 weeks. The physical fitness tests and questionnaire of both group are performed before and after the 12-week exercise program.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress84%
Jul 2019Aug 2027

Study Start

First participant enrolled

July 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

8.1 years

First QC Date

September 11, 2019

Last Update Submit

December 17, 2025

Conditions

Elderly Exercise

Outcome Measures

Primary Outcomes (2)

  • 30 second chair stand test

    number of full stands that can be completed in 30 seconds with arms folded across chest.

    baseline

  • 30 second chair stand test

    number of full stands that can be completed in 30 seconds with arms folded across chest.

    after 12-week intervention

Secondary Outcomes (25)

  • BMI

    baseline

  • BMI

    after 12-week intervention

  • SMI

    baseline

  • SMI

    after 12-week intervention

  • Back scratch

    baseline

  • +20 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Ctrl group is instructed to maintain their original daily life

Smart Exercise group

EXPERIMENTAL

SE group are instructed to perform one session of upper extremity ergometer and one session of lower extremity ergometer in a week, 30 minute per session, lasting for 12 weeks.

Device: smart exercise system

Interventions

smart exercise systemDEVICE

The smart exercise system contains an upper extremity ergometer (UEE) and a lower extremity ergometer (LEE). The revolutions per minute (RPM) of the ergometer are instructed to maintain in 55-65. The resistance of UEE is set from level 1 at the first session, and adjusted by rating of perceived exertion (RPE) of each user after each end of the session. The resistance of LEE is set from level 2 at the first session, and adjusted by rating of perceived exertion (RPE) of each user after each end of the session.

Smart Exercise group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult over 50 years old
  • No significant limb disability or joint deformation
  • No history of cardiovascular disease
  • Never lost balance due to dizziness in the past 12 months

You may not qualify if:

  • limb disability or joint deformation
  • history of cardiovascular disease
  • lost balance due to dizziness in the past 12 months
  • cognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University

Tainan, Taiwan, 701, Taiwan

RECRUITING

Related Publications (1)

  • Lin CC, Lin YS, Yeh CH, Huang CC, Kuo LC, Su FC. An Exergame-Integrated IoT-Based Ergometer System Delivers Personalized Training Programs for Older Adults and Enhances Physical Fitness: A Pilot Randomized Controlled Trial. Gerontology. 2023;69(6):768-782. doi: 10.1159/000526951. Epub 2023 Jan 6.

    PMID: 36617413DERIVED

Study Officials

  • Li-Chieh Kuo, Ph. D.

    National Cheng-Kung University Hospital

    STUDY DIRECTOR

Central Study Contacts

Li-Chieh Kuo, Ph. D.

CONTACT

886-62353535jkkuo@mail.ncku.edu.tw

Chih-Chun Lin, Ph. D.

CONTACT

886-62757575z9902026@email.ncku.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2019

First Posted

October 24, 2019

Study Start

July 15, 2019

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

December 24, 2025

Record last verified: 2025-12

Locations

TW(1)