跳至主要内容
临床试验/NCT04549103
NCT04549103已完成不适用

Effect of Community-based Baduanjin (八段锦) on Functional Performance in Pre-Frail/Frail Older Adults: A Randomised Controlled Trial

Geriatric Education and Research Institute1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年4月30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
发起方
入组人数
58
试验地点
1
主要终点
Change in Knee Extension Strength

研究概览

简要总结

The aim for this study is to investigate the effectiveness of a 16-week realistic community-delivered Baduanjin training program compared to a waitlist control intervention, in improving functional outcomes among pre-frail and frail older adults in Singapore. It is hypothesized that participants that receive 16-week of BDJ training will have significant improvement in physical function (including balance, muscle strength, and endurance); alleviate exhaustion; reduce risk of falling and fear of falling; potentially reverse frailty; reduce depression; and improve quality of life, potentially with greater improvements in area(s) for individuals with lower baseline measures. Whereas, participants in the waitlist control group, will have insignificant changes to their baseline measures.

研究设计

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

入排标准

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

入选标准

  • •Pre-frail and frail adults aged 55 years and above
  • •Able to ambulate (move about) without personal assistance and has no other physical limitations affecting participation and adherence
  • •Able to understand basic instructions
  • •Generally sedentary lifestyle

排除标准

  • •Participating in other intervention studies
  • •Perform regular moderate to vigorous intensity exercise
  • •Perform regular Taichi or Qigong exercise
  • •Have severe audio-visual impairment
  • •Diagnosed with cognitive impairment (e.g. dementia, Alzheimer's Disease) and/or history of neurological disorder (e.g. cerebral palsy, Parkinson's Disease)
  • •Diagnosed with postural hypotension (have a drop of 20mmHg systolic blood pressure, or a drop of 10mmHg diastolic blood pressure within two to five minutes of standing up, or if standing causes signs and symptoms)
  • •Unable to participate for the full duration of the study
  • •Unable to come to the training site by himself/herself or by the help of caregivers
  • •Not suitable to participate in exercise as deemed by a medical doctor

研究组 & 干预措施

Intervention Group

Experimental

Intervention group will receive the 16-week Baduanjin exercise intervention.

干预措施: Baduanjin exercise program (Other)

Control Group

No Intervention

Control group will not receive the exercise intervention, but they will attend four education classes about managing their health status.

结局指标

主要结局

Change in Knee Extension Strength

时间窗: Baseline, and after 16-weeks of intervention

Knee extension strength is measured using a digital dynamometer gauge. Prior to performing the test, leg dominant is determined by asking participants which is their dominant leg or which leg they would predominantly use when performing a task. For the assessment, participants will be asked to extend their leg against the spring gauge while seated with the hip and knee joint angles positioned at 90°. Maximal force is recorded in kilograms.

Change in Maastricht Vital Exhaustion Score (MQ)

时间窗: Baseline, and after 16-weeks of intervention

Maastricht vital exhaustion score (MQ) is a short questionnaires that requires between 5 to 10 minutes for completion. MQ is a validated tool to assess feelings of "vital exhaustion", which has three defining characteristics: (1) feeling of excessive fatigue and lack of energy, (2) increased irritability, and (3) feelings of demoralization.

Change in Falls Efficacy Scale-International (FES-I)

时间窗: Baseline, and after 16-weeks of intervention

The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the fear of falling in older population during social and physical activities inside and outside the home. The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned). The 16-item FES-I is a well validated and feasible measure to assess fear of falling in older persons, and predicts future risks of falls.

次要结局

  • Change in EuroQol-Five Dimensions (EQ-5D)(Baseline, and after 16-weeks of intervention)
  • Change in Geriatric Depression Scale (GDS)(Baseline, and after 16-weeks of intervention)
  • Change in Physiological Profile Assessment. (PPA - Short Form)(Baseline, and after 16-weeks of intervention)
  • Change in 6-meter Fast Gait Speed Test(Baseline, and after 16-weeks of intervention)
  • Change in Frailty Score(Baseline, and after 16-weeks of intervention)
  • Change in Hand Grip Strength(Baseline, and after 16-weeks of intervention)
  • Change in 30 seconds Sit-to-stand (STS)(Baseline, and after 16-weeks of intervention)
  • Change in Time Up and Go test (TUG)(Baseline, and after 16-weeks of intervention)

研究者

发起方
Geriatric Education and Research Institute
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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