Effect of Brain Gym® Program on Postural Control,Functional independence and Quality of Life in Community dwelling frail geriatric population: A mixed method study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- PHASE 2 (Intervention)
研究概览
简要总结
Frailty is an aging syndrome in which there is loss of harmonic interaction between genetic, biological, functional, cognitive, psychological and socio-economic domains that result in impaired postural control, obesity, frequent hospitalizations, falls, disabilities in daily living, poor quality of life, increased healthcare utilization, and higher mortality. Frailty maybe reversible through targeted interventions. Currently few studies have assessed frailty prevalence on a large scale. Though there are many exercise interventions which improve the quality of life and functional independence , the specific exercise improving functional independence remain unclear. Few studies have exercise interventions addressing multiple components of postural control. Brain Gym® Program is hypothesized to improve sensorimotor coordination, improve balance, stress response by specific patterns of body movements which can stimulate the corollary functions of the brain as well as the vestibular system. Although research has shown positive effect of Brain Gym® Program in improving cognition, balance, muscle power which are also affected in frailty, so far effect of Brain Gym® Program has been scarcely explored in frail population and the quality of evidence is low. Hence, the questions which arise are 1 What is the current prevalence of frailty 2 Is Brain Gym® Program effective in frailty ? . Hence this study aims to find an answer to the questions by a mixed method study in which Phase 1 aims to find the prevalence of frailty in geriatric population and Phase 2 is a randomized control trial in which the experimental group shall receive Brain Gym® Program and the Control group shall receive multicomponent exercises and effectiveness of Brain Gym® Program versus conventional exercise shall be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 65.00 Year(s) 至 74.00 Year(s)（—）
- 性别
- All
入选标准
- •PHASE 1 Community dwelling men and women between age 65-74 years of age, willing to participate.
- •Able to follow instructions and answer clearly.
- •PHASE 2 Geriatric population with score between 8-11 (Mild to moderate frailty) on Edmonton Frail Scale .
- •Scoring 1 on Functional performance domain of Edmonton Frail Scale i.e. time taken between 11-20 seconds to complete the test.
排除标准
- •PHASE 1 Diagnosed with dizziness, vertigo Carcinoma Neurological conditions including diagnosed neuropathies, Parkinsonism, stroke Recent history of any type of surgery or injury including fall within last 3 months Visual or hearing impairment Severe cardiovascular event within last 3 months Institutionalized adults Patients with severe musculoskeletal pain Uncontrolled BP i.e. more than 140 mm Hg and 90 mm Hg Uncontrolled Diabetes i.e. HbA1c more than 8 according to ICMR guidelines 2018 Diabetic neuropathy including ulcers tested by Ipswitch touch test PHASE 2 Participants involved in fitness activities Scoring 0 i.e. Normal or 2 i.e. Severe impairment.
- •which means time taken less than 10 seconds or more than 20 seconds on Functional performance of Edmonton Frail scale Participants excluded in PHASE 1.
结局指标
主要结局
PHASE 2 (Intervention)
时间窗: PHASE 2 - Baseline, 6 weeks and 12 weeks
Postural Control using Plantar pressure system OHM 3000
时间窗: PHASE 2 - Baseline, 6 weeks and 12 weeks
次要结局
未报告次要终点
研究者
Heta Baxi
Parul university