Effect of a comprehensive rehabilitation program using digital technology on lower extremity function and quality of life in community-dwelling older adults with type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 1. lower extrimity function- Lower Extremity functional scale (LEFS), walking performance & functional capacity using 6 minute walk distance, Mobility using Timed up & go test, gait speed, lower extremity strength & balance using Short physical performance battery & flexibility using sit and reach test
研究概览
简要总结
The aim of this study is To develop and test the effects of a comprehensive rehabilitation program delivered through digital technology on lower limb function and quality of life in community dwelling older adults with type 2 Diabetes Mellitus. This study is divided into two phases: phase 1 is the Design, Development and validation of a mobile health application for the delivery of a comprehensive rehabilitation program for community-dwelling older adults with type 2 DM and phase 2 is a randomized controlled trial to look at the Effect of a comprehensive rehabilitation program delivered through a mobile health application on lower extremity function and quality of life in community dwelling older adults with type 2 DM. Digital technology in terms of use mobile phones is becoming an important tool and the healthcare sector has seen a paradigm shift towards digital health. The benefits include time and cost savings, shortened waiting time and improved quality of life.The use of digital technology is emerging as a way of delivering exercises. Such interventions can aid elderly in exercising at their preferred time and location.Currently there is limited understanding and evidence on the effect of use of smartphones for the delivery of exercises in older adults with type 2 DM. If digital interventions can be proven effective, Comprehensive rehabilitation interventions delivered through digital technology can be prescribed to older adults with type 2 DM, increasing the reach to a wider population. Hence through this study, we will study the effects of a comprehensive rehabilitation program using digital technology on lower extremity function and quality of life in community-dwelling older adults with type 2 DM
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Older adults between 60 to 75 years Minimum duration of type 2 Diabetes mellitus.
- •one year 5 repetitions sit to stand test score above 11.6 seconds Older adults with functional vision & hearing Participants using an android based smartphone or primary informal caregiver who is living with the older adult has a smartphone with android version 4.0 or above Participants who can read and comprehend Kannada or English Have internet access on smartphone through Wi-Fi/Mobile data Either gender Able to ambulate independently without walking aids.
排除标准
- •Older adults who are immobile Any neurological impairment (eg: Stroke, Parkinsonism) which can impair mobility Individuals with open foot ulcers Any Chronic or Acute injury which could affect participation in the rehabilitation program Cognitive impairment (Mini Cog score of 2 or less than 2) Uncontrolled hypertension Any major cardiac event in the past 6 months.
结局指标
主要结局
1. lower extrimity function- Lower Extremity functional scale (LEFS), walking performance & functional capacity using 6 minute walk distance, Mobility using Timed up & go test, gait speed, lower extremity strength & balance using Short physical performance battery & flexibility using sit and reach test
时间窗: Before the intervention & 12 weeks after
2. Quality of Life using SF-36
时间窗: Before the intervention & 12 weeks after
次要结局
- Physical activity - Global physical activity questionnaire (GPAQ)(Behavioral changes related to foot care (Knowledge & Practice of footcare)-Nottingham Assessment of Functional Footcare (NAFF))