NCT06814678

Brief Summary

This clinical trial aims to evaluate the effectiveness of interactive exergaming combined with Otago Exercise Program on mobility among community-dwelling older adults aged 65 and above. The main research questions are: Does this combined exercise intervention improve elderly mobility? Does this program enhance muscle strength and psychological well-being? Researchers will compare two groups: one group will do the combined exercise program for 12 weeks, while the other group will continue their usual activities. Participants will:

  • Have their health checked three times: at the start, after 12 weeks, and 3 months later
  • If in the exercise group, attend exercise sessions twice a week for 12 weeks
  • Complete tests about their physical abilities and how they feel emotionally Who can take part:
  • Adults age 65 or older
  • People who need more than 12 seconds to stand up and sit down 5 times
  • People who can stand for at least 30 seconds with support People cannot take part if they have serious vision problems, recent leg injuries, major illnesses, significant memory problems, or mental health conditions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

February 11, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

January 24, 2025

Last Update Submit

February 2, 2025

Conditions

Keywords

Otago Exercise ProgramInteractive exergamingMobility declineCommunity-dwelling older adultsPhysical performanceIntrinsic capacityPsychological healthMuscle strength

Outcome Measures

Primary Outcomes (2)

  • Mobility Performance

    Measured by Short Physical Performance Battery (SPPB) Scale: 0-12 points, higher scores indicate better performance

    Baseline, 12 weeks, 3 months

  • Lower Extremity Strength

    Measured by digital dynamometer Unit: Kilograms (kg)

    Baseline, 12 weeks, 3 months

Secondary Outcomes (4)

  • Intrinsic Capacity Score

    baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)

  • Loneliness Level

    Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)

  • Depression Symptoms

    Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)

  • Well-being Status

    Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)

Study Arms (2)

Control Group with Usual Care

PLACEBO COMPARATOR

Participants in the control group will maintain their usual daily activities and routine care without any specific exercise intervention during the 12-week study period. They will receive standard health education materials and regular check-ups but no structured exercise program

Other: Control Group with Usual Care

Interactive Exergaming with Otago Exercise Program

EXPERIMENTAL

A 12-week structured program consisting of 120 minutes per week divided into two 60-minute sessions. Each session combines Otago Exercise Program for strength and balance with interactive exergaming activities, conducted in community centers under certified instructor supervision with standardized equipment. Exercise intensity progresses according to individual performance.

Behavioral: Interactive Exergaming with Otago Exercise Program

Interventions

Participants will receive a 12-week structured program combining interactive exergaming and Otago Exercise Program. Sessions include balance training, strength exercises, and functional mobility activities delivered through interactive gaming platforms, supervised by trained instructors.

Interactive Exergaming with Otago Exercise Program

Participants will maintain their regular activities at community centers or facilities, including cognitive therapy, oral exercises, and upper limb training programs, during the 12-week study period

Control Group with Usual Care

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65 years
  • Abnormal mobility based on ICOPE screening (Five-time chair stand test \> 12 seconds)
  • Able to stand holding handrail for \> 30 seconds

You may not qualify if:

  • Severe visual impairment
  • Lower limb fracture
  • Acute serious illness
  • Moderate to severe cognitive impairment (SPMSQ \> 5 errors)
  • Diagnosed psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 105, Yusheng Street, Shilin District, Taipei City 111, Taiwan

Taipei, Taipei, 111024, Taiwan

Location

MeSH Terms

Conditions

Psychological Well-BeingMobility Limitation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

JIA-JING SUN, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor who performs all measurements and evaluations will be blinded to group allocation throughout the study period. This assessor will not be involved in intervention delivery or have any contact with participants during exercise sessions to maintain masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This cluster-randomized controlled trial uses parallel assignment where community centers are randomly allocated to either receive interactive exergaming combined with Otago Exercise Program intervention or usual care control group. All eligible participants within each cluster follow the same intervention protocol
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate, Registered Nurse

Study Record Dates

First Submitted

January 24, 2025

First Posted

February 7, 2025

Study Start

February 11, 2025

Primary Completion

December 15, 2025

Study Completion

March 31, 2026

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Protection of participant privacy and confidentiality. Institutional policies and ethical review board requirements.

Locations