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临床试验/NCT06489834
NCT06489834进行中(未招募)不适用

Group Drumming for Improving the Health of Community-Dwelling Elderly

KK Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300
试验地点
1
主要终点
Sleep Quality

研究概览

简要总结

The study seeks to examine the effects that recreational group drumming has on the health of the community- dwelling elderly. It is hypothesized that it has positive and sustainable effects on various health outcome measures.

详细描述

The study seeks to examine the effects that recreational group drumming has on the health of the community- dwelling elderly. It is hypothesized that it has positive and sustainable effects on various health outcome measures.

One of the primary outcome measure is the quality of life of the participants, which will be measured using the European Quality of Life-5 Dimensions (EQ5D). It is a measure of health status from the EuroQoL. Group primarily designed for self-completion by respondents and is validated locally. The score ranges from 0 (death) to 1 (full health), with 5 dimensions comprising of mobility, self-care, usual activities, pain/discomfort and anxiety/ depression.

The other primary outcome measures include:

i. The Geriatric Depression Scale (GDS), which is a tool used for elderly population to evaluate the level of depressive symptoms of an individual over the past week, has been validated locally. It is a self-reported questionnaire consisting of 15 items. Maximum score of 15 and minimum of 0. Score equal or greater than 6 out of 15 is considered to be indicator of depression.

ii. The Pittsburgh Sleep Quality Index (PSQI) is a self-reported measure of sleep quality. It is a 19-item scale grouped into 7 equally weighted component scores. The global score ranges from 0 to 21, with poorer sleep quality indicated by a higher global score.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Assessor would be blinded to which arm the participants is in. Investigator will also be blinded to the treatment.

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Individuals who are:
  • •Aged 60 years old and above (by year of age)
  • •Able to understand English and/or Mandarin, and
  • •Able to engage in the group drumming activity conducted (e.g. capable of light exercises while seated)

排除标准

  • •Individuals who are:
  • •On palliative care, and/or
  • •Bed-bound
  • •Have severe hearing impairment such that they are unable to engage in group drumming sessions

研究组 & 干预措施

Drumming Arm

Active Comparator

Participants in this arm will undergo weekly group drumming for 8 weeks.

干预措施: Group Drumming (Other)

Waitlist Control Arm

No Intervention

Participants in this arm will not undergo any intervention while the intervention arm is ongoing and assessed for comparison.

结局指标

主要结局

Sleep Quality

时间窗: 12 weeks

Pittsburg Sleep quality index will be used to measure this outcome

Health related quality of life

时间窗: 12 weeks

European Quality of Life-5 Dimensions (EQ5D) Will be measured. The score ranges from 0 (death) to 1 (full health), with 5 dimensions comprising of mobility, self-care, usual activities, pain/discomfort and anxiety/ depression.

Depression

时间窗: 12 weeks

Geriatric Depression Scores will be measured. Scores will range from 0-15. Those will lower scores will have higher risk of depression

次要结局

  • Psychological effects(12 weeks)
  • Resting Blood Pressure(12 weeks)
  • Heart Rate(12 weeks)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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