跳至主要内容
临床试验/NCT05527574
NCT05527574已完成不适用

Development of an Innovative Home-based Strategy for FrAilty preveNTion in AdultT With dIabetes and Chronic Kidney Disease (FANTASTIC)

University of Alberta2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年11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
入组人数
120
试验地点
2
主要终点
Changes in frailty status in response to the exercise intervention

研究概览

简要总结

One of the most common problems in people with diabetes (DM) and chronic kidney disease (CKD) is the high frequency of other coinciding medical conditions such as osteoporosis and frailty. Frailty in particular is very common in adults with DM and CKD and it can result in significant muscle weakness which can result in increasing difficulties with performing activities of daily life (ADL). This can lead to an increase risk for falls, bone fractures and increasing hospitalization. The investigators have showed that adults with DM and CKD who have frailty use hospital services more frequently, have reduced quality of life and difficulties with performing their ADLs1. There is some evidence that early screening for frailty and lifestyle interventions that focus on healthier eating and physical activity can help prevent frailty from getting worse. The study purpose is to develop and test a home-based lifestyle intervention program focused on optimizing diet and the ability to perform your ADLs in adults with DM and CKD. The goal of this program is to ensure that adults with DM can live healthier lives within the community.

详细描述

Research Hypothesis: A home based video program focused on education related to lifestyle modification (diet, physical activity) over 6 months will result in improved measures of muscle strength/muscle functionality, health related quality of life and reduced measures of frailty and health care utilization in adults with DM and CKD.

V. Expected Outcomes: Results from this study will address two important questions a) identification of features of frailty/pre-frailty in adults with DM and CKD who should be targeted for lifestyle intervention b) development of home based programming for individuals with pre-frailty/frailty in the community dwelling adults with DM. This information is needed to help our clinical teams screen for frailty/pre-frailty and to focus health care resources on developing rehabilitation strategies to prevent and treat adults patients with DM and Frailty. This is particularly relevant for those who are 'vulnerable to Frailty' (pre-frail), but do not have the full condition. Prevention of the progression to full FRAILTY is critical to ensure optimal mental health HRQOL, to reduce health care use and to improve diabetes interventions in the community for those most vulnerable (Core Area 1). This will promote healthy aging in the community setting in obese adults with DM by supporting independent living, quality of life, mental health and delayed care utilization (Core Area 2) and will ensure healthy lives and promote well-being of all adults with DM at all ages (Goal 3).

Study Design:

There are two phases of this study. 1) Development of Video programming and 2) Open-label non-blinded study.

Phase 1 (see Table 1): Home Video content will be developed based on the principals of social cognitive theory. Video content will include two components a) resistance exercise (based on Canadian Diabetes Association video's that are adapted to meet the patient's functional capacity and b) the concepts of nutrition literacy. This will be done so a comprehensive approach to the lifestyle factors known to contribute to frailty (diet, exercise) can be developed in the educational programming of the video content (mp4 files). The resistance exercises will based upon Diabetes Canada resistance exercises which will have been adapted to meet the functional abilities of the patients in this population (based on the Investigator's earlier studies in DM and CKD) (Mager et al Can J Diabetes 2019) and https://www.diabetes.ca/getmedia/0a646e26-9e1c-4769-975f-51876edf6ecd/resistance-band-exercises-2.pdf.aspx ). Video content filming will be supported in the field by trained RA/graduate student and exercise specialists and then vetted for content and face validity by experts in the field (PT, MD, RD, geriatrician and exercise specialist CI and collaborators). We will also elicit patient feedback in vetting video content from participants from ongoing studies in the area (Pro00049292) and/or by recruiting potentially interested patients in the clinics. Participants who participate in this phase of the study will not be enrolled into Phase 2 of the study.

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
None

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (50-85 years)
  • Clinically Diagnosed with diabetes (Type 2) and stage 1-IV CKD (Glomerular Filtration - Rate (GFR) 10-89 ml/min/1.73m2).

排除标准

  • Functional and cognitive impairments (MMSE scores<24)
  • Severe, permanent vision loss.
  • Recent history of bone fracture in the last 12 months
  • History of skeletal muscular disorders which precludes the ability to perform resistance exercises (e.g., moderate to severe osteoarthritis that prevents walking, bending and/or sit to stand or wheelchair dependent)
  • Pregnant women
  • Dialysis (hemodialysis or peritoneal dialysis) as treatment of kidney disease

研究组 & 干预措施

Standard of Care or Control Frail

No Intervention

Standard of Care (standard diet and physical activity education) for Frail Participants

Exercise Intervention Frail

Experimental

Resistance Exercise Intervention (home video education: resistance training and diet education) for Frail participants

干预措施: Resistance Exercise (Other)

Exercise Intervention Pre-Frail

Experimental

Resistance Exercise Intervention (home video education: resistance training and diet education) for Pre-Frail participants

干预措施: Resistance Exercise (Other)

Standard of Care or Control Pre-Frail

No Intervention

Standard of Care (standard diet and physical activity education) for Pre-Frail Participants

结局指标

主要结局

Changes in frailty status in response to the exercise intervention

时间窗: Six months

Changes in frailty status (Edmonton Frailty Scoring System) in response to the home-based rehabilitation protocol vs standard of care over six months. Values in the Edmonton Frailty Scale range from 0-18 ; where values 0-5 are non-frail, 6-7 apparently frail vulnerable, 8-9 mild frailty, 10-11 moderately frail and 12-18 severely frail.

次要结局

  • Changes in total skeletal muscle mass surface area in response to exercise intervention(Six months)
  • Changes in health related quality of life (HRQOL)(Six months)
  • Changes in cognitive health(Six months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验