NCT05887648

Brief Summary

The aims of the research are to develop an age-appropriate and culturally sensitive older person-centered, Singapore-contextualized Dance-based Exergame (SinDance), and to pilot test its effectiveness in improving physical function and activity daily living (ADL) and reducing depressive symptoms and falls among community-dwelling older people. It is hypothesized that participants in the SinDance will have: (1) improved postural balance, muscle strength, and ADL; and (2) reduced depressive symptoms, fear of falling, and number of falls, compared to those in the control group. The research will be structured as a two-phase study.

  • Eligible participants will be recruited from Lions Befrienders (LB) senior activity centre and randomly assigned to the SinDance group or the control group.
  • Participants in the intervention group will receive one face-to-face briefing session and will be required to participate in the newly developed SinDance exergame 3 times a week for 6 weeks, while those in the control group will attend usual activities provided by the centers.
  • Outcomes will be measured at baseline, immediate after intervention, and 3 months from baseline.

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 Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

Study Start

First participant enrolled

April 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

May 9, 2023

Last Update Submit

May 13, 2024

Conditions

Keywords

fallsactivities of daily livingexercisedanceexergame

Outcome Measures

Primary Outcomes (21)

  • Short Fall Efficacy Scale International (short FES-I)

    Scores range from 7 to 28 and lower scores indicate a better outcome (lower fear of falling).

    Baseline

  • Short Fall Efficacy Scale International (short FES-I)

    Scores range from 7 to 28 and lower scores indicate a better outcome (lower fear of falling).

    6 weeks from baseline

  • Short Fall Efficacy Scale International (short FES-I)

    Scores range from 7 to 28 and lower scores indicate a better outcome (lower fear of falling).

    3 months from baseline

  • 15-item Geriatric Depression Scale (GDS-15)

    Scores range from 0-15, and higher scores indicate a worse outcome (depression).

    Baseline

  • 15-item Geriatric Depression Scale (GDS-15)

    Scores range from 0-15, and higher scores indicate a worse outcome (depression).

    6 weeks from baseline

  • 15-item Geriatric Depression Scale (GDS-15)

    Scores range from 0-15, and higher scores indicate a worse outcome (depression).

    3 months from baseline

  • Frenchay Activities Index (FAI)

    Scores range from 15-60 and higher scores indicate better outcome (better ability to engage in activities of daily living)

    Baseline

  • Frenchay Activities Index (FAI)

    Scores range from 15-60 and higher scores indicate better outcome (better ability to engage in activities of daily living)

    6 weeks from baseline

  • Frenchay Activities Index (FAI)

    Scores range from 15-60 and higher scores indicate better outcome (better ability to engage in activities of daily living)

    3 months from baseline

  • Five times sit-to-stand test (FTSTS)

    A longer time taken to complete the test indicates a worse outcome (weaker functional lower limb muscle strength)

    Baseline

  • Five times sit-to-stand test (FTSTS)

    A longer time taken to complete the test indicates a worse outcome (weaker functional lower limb muscle strength)

    6 weeks from baseline

  • Five times sit-to-stand test (FTSTS)

    A longer time taken to complete the test indicates a worse outcome (weaker functional lower limb muscle strength)

    3 months from baseline

  • Time Up & Go Test (TUG)

    A longer time to complete the test indicates a worse outcome (poorer mobility)

    Baseline

  • Time Up & Go Test (TUG)

    A longer time to complete the test indicates a worse outcome (poorer mobility)

    6 weeks from baseline

  • Time Up & Go Test (TUG)

    A longer time to complete the test indicates a worse outcome (poorer mobility)

    3 months from baseline

  • Functional Reach Test

    A longer reach distance indicates a better outcome (better balance)

    Baseline

  • Functional Reach Test

    A longer reach distance indicates a better outcome (better balance)

    6 weeks from baseline

  • Functional Reach Test

    A longer reach distance indicates a better outcome (better balance)

    3 months from baseline

  • Modified Barthel ADL Index

    Scores range from 0-20, and higher scores indicate a better outcome (functional independence in the domains of personal care and mobility)

    Baseline

  • Modified Barthel ADL Index

    Scores range from 0-20, and higher scores indicate a better outcome (functional independence in the domains of personal care and mobility)

    6 weeks from baseline

  • Modified Barthel ADL Index

    Scores range from 0-20, and higher scores indicate a better outcome (functional independence in the domains of personal care and mobility)

    3 months from baseline

Secondary Outcomes (4)

  • Attendance (for SinDance group only)

    Each session during the 6-week intervention (total of 18 sessions)

  • Level of motivation (for SinDance group only)

    Each session during the 6-week intervention (total of 18 sessions)

  • Level of enjoyment (for SinDance group only)

    Each session during the 6-week intervention (total of 18 sessions)

  • Duration of play (for SinDance group only)

    Each session during the 6 week intervention (total of 18 sessions)

Study Arms (2)

SinDance

EXPERIMENTAL

Participants in the SinDance group will attend an educational briefing session on the importance of exercising, and participate in a 6-week SinDance exergame intervention

Behavioral: SinDance

Control

NO INTERVENTION

Participants in the control group will attend usual activities offered by the senior activity centres. The control group will be offered an opportunity to play the SinDance exergame after completing the last data collection (i.e. 3-months from baseline).

Interventions

SinDanceBEHAVIORAL

One face-to-face briefing session (20 min) will be offered to participants in the SinDance group as part of promoting physical activity and safe exercise for older adults. Participants will be asked to engage in SinDance 3 times a week for 6 weeks. Each session will last for about 30-40 mins, including 5 mins warm up exercise before the game and 5 mins cool down exercise afterwards. All the game play sessions will be conducted in LB centres. Each participant will play the game individually. To play the game, participants will dance to the dance moves shown on the screen (on the external monitor or the projected screen) and as they get each move right, they will be awarded points. The more accurate their moves are, the more points they get in the game. During the gameplay, the participants will be instructed to stop and rest if they are tired. A RN/RA will be on site to observe the safety of exergaming and to help resolve technical issues as they arise.

SinDance

Eligibility Criteria

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

You may qualify if:

  • Age 60 and above
  • Living in the community
  • Independent without use of walking aids
  • able to read and understand English or Chinese
  • TUG \< 30s
  • Mini-Cog test score of 3 and above

You may not qualify if:

  • Are suffering from mental disorders or cognitive impairment that will prevent individuals from understanding the study and performing the exergame correctly and safely (e.g. Alzheimer's disease)
  • \- Mini-Cog less than 3
  • have a pre-existing medical condition that prohibits exercise, or prevents the individual from performing the exergame correctly and safely, including but not limited to:
  • chest pain or chest tightness during physical activities (e.g. walking, climbing stairs, doing household chores or similar activities
  • heart failure
  • currently experience dizziness or light-headedness, uncontrolled/unstable high blood pressure
  • have physical limitations, for examples:
  • wheelchair bound
  • pain, stiffness or swelling that will prevent the individual from doing what he/she wants or need to do
  • feel unsteady, use an assistive device while standing or walking
  • TUG equal or more than 30 seconds
  • have visual or hearing impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Lions Befrienders Active Ageing Centre @ CLEMENTI 344

Singapore, 120344, Singapore

Location

Lions Befrienders Active Ageing Centre @ CLEMENTI 366/367

Singapore, 120366, Singapore

Location

Lions Befrienders Active Ageing Centre @ CLEMENTI 420A

Singapore, 121420, Singapore

Location

Lions Befrienders Active Ageing Centre @ Bendemeer 32

Singapore, 330032, Singapore

Location

Lions Befrienders Active Ageing Centre @ Tampines 499C

Singapore, 523499, Singapore

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ying Jiang, PhD

    Alice Lee Centre for Nursing Studies, National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomised into 2 groups - SinDance (interventional group) or control group. A computerised randomisation programme will generate the randomization list and a person independent from the study will prepare the sealed envelopes according to the generated randomisation list. After a participant is registered, a unique participant enrolment ID will be assigned to the participant. The envelope according to the enrolment ID will be opened on site and the participant will be allocated into either one of the two groups based on the randomisation list the group indicated.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 5, 2023

Study Start

April 5, 2023

Primary Completion

January 24, 2024

Study Completion

January 24, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Anonymised study results and data will be available to researchers who request it as part of an IPD study or meta-analysis that has been prospectively registered and a protocol by a representative researcher is provided to verify the legitimacy of the request.

Shared Documents
ICF
Time Frame
Data will be available following publication of the study's results in a peer-reviewed journal
Access Criteria
Anonymised study results and data will be available to researchers who request it as part of an IPD study or meta-analysis that has been prospectively registered and a protocol by a representative researcher is provided to verify the legitimacy of the request.

Locations