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临床试验/NCT05887648
NCT05887648已完成不适用

Effect of Singapore-contextualized Dance-based Exergame (SinDance) in Promoting Physical Function and Reducing Depressive Symptoms and Falls Among Community-dwelling Older Adults: A Randomised Controlled Trial

National University of Singapore5 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
5
主要终点
Short Fall Efficacy Scale International (short FES-I)

研究概览

简要总结

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.

  1. In Phase one, development of the SinDance system will be undertaken.
  2. In Phase two, a pilot randomized control trial will be conducted to evaluate the feasibility and potential effectiveness of the newly developed SinDance exergame on the proposed outcomes.
  • 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.

详细描述

SinDance will be structured as a two-phase study involving a multi-disciplinary team of software engineers, occupational therapist (OT), and research nurse (RN).

Phase 1: Development of the SinDance system will be undertaken by software engineers in collaboration with an OT and RN.

  • The SinDance intervention is a 6-week program consisting of one face-to-face briefing session provided by the Research Nurse (RN)/Research Assistant (RA) and SinDance exergaming. The dance movements will be choreographed for older adults based on local context and culture. The game design of SinDance will be developed on cross-platform game engine called Unity. Body movements will be captured via an external RGB camera. Using an open pose algorithm, the system will be able to track correct body movements based on image processing and body posture recognition, as well as provide active feedback on performance. This allows for real-time movement adjustments by the user to achieve higher compliance rating. Points will be awarded for each correct movement accomplished.
  • The SinDance intervention is designed as a leisure game to supplement the daily physical activities of older adults. There will NOT be strenuous or intense physical activities or any vigorous high-velocity movements in this intervention.

Considering that SinDance is a self-regulated exercise, to ensure safety during self-regulated exercise, dance choreography will be designed with varying levels of movement difficulty, speed and rhythm tempo to cater to the different needs of individual participants. The SinDance game interface will be designed with minimal action buttons to enhance usability and user- experience for older people to operate.

Phase 2: Pilot test to assess the effectiveness of SinDance exergame Study Design - A pilot two-arm randomized control trial with repeated measures will be conducted in Phase 2. Eligible participants will be recruited from Lions Befrienders (LB) senior activity centre. They will be randomly allocated to either intervention group or control group using block randomisation technique. The data will be collected at baseline, immediately after the intervention (i.e., 6 weeks from baseline) and 3 months from baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

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

干预措施: SinDance (Behavioral)

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).

结局指标

主要结局

Short Fall Efficacy Scale International (short FES-I)

时间窗: 3 months from baseline

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

Time Up & Go Test (TUG)

时间窗: 3 months from baseline

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

15-item Geriatric Depression Scale (GDS-15)

时间窗: 3 months from baseline

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

Frenchay Activities Index (FAI)

时间窗: 3 months from baseline

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

Modified Barthel ADL Index

时间窗: 3 months from baseline

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

Five times sit-to-stand test (FTSTS)

时间窗: 3 months from baseline

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

Functional Reach Test

时间窗: 3 months from baseline

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

Short Fall Efficacy Scale International (short FES-I)

时间窗: Baseline

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

Short Fall Efficacy Scale International (short FES-I)

时间窗: 6 weeks from baseline

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

15-item Geriatric Depression Scale (GDS-15)

时间窗: Baseline

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

15-item Geriatric Depression Scale (GDS-15)

时间窗: 6 weeks from baseline

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

Frenchay Activities Index (FAI)

时间窗: Baseline

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

Frenchay Activities Index (FAI)

时间窗: 6 weeks from baseline

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

Five times sit-to-stand test (FTSTS)

时间窗: Baseline

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

Five times sit-to-stand test (FTSTS)

时间窗: 6 weeks from baseline

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

Time Up & Go Test (TUG)

时间窗: Baseline

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

Time Up & Go Test (TUG)

时间窗: 6 weeks from baseline

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

Functional Reach Test

时间窗: Baseline

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

Functional Reach Test

时间窗: 6 weeks from baseline

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

Modified Barthel ADL Index

时间窗: Baseline

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

Modified Barthel ADL Index

时间窗: 6 weeks from baseline

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

次要结局

  • Duration of play (for SinDance group only)(Each session during the 6 week intervention (total of 18 sessions))
  • Attendance (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))
  • Level of motivation (for SinDance group only)(Each session during the 6-week intervention (total of 18 sessions))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiang Ying

Assistant Professor

National University of Singapore

研究点 (5)

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