NCT04091308已完成不适用
Individualized Physical Exercise Training and Enhanced Protein Intake in Older Citizens During Municipality-based Rehabilitation
University College Absalon2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Short Musculoskeletal Function Assessment (SMFA) - Dysfunction Index
研究概览
简要总结
The study will investigate if: 1) individualized physical exercise training in combination with extra protein intake can increase measures on all three ICF-levels? 2) extra protein intake alone increases outcomes of usual care treatment?
详细描述
Successful rehabilitation of the growing number of elderly citizens can lead to preservation of functional independence and improvement in the quality of life.
The aim of the study is to investigate the effect of an individually tailored physical exercise training program combined with increased protein intake in order to improve measures on all three ICF levels (International Classification of Functioning, Disability, and Health). By conducting the study in a real-life clinical setting, research is translated into practice involving health professionals and the target group in the development of new knowledge on how to enhance the outcome of rehabilitation, thereby increasing the overall capacity of the elderly citizen, and decreasing the expenditure of health-services.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All citizens that are referred to the health/rehabilitation center age 65 years and older from Slagelse municipality will be invited to a screening interview with a physiotherapist after which the participant will be asked to join the study if not subject to one of the following
排除标准
- •Exclusion Criteria:
- •inability to speak or read Danish,
- •renal diseases,
- •active cancer,
- •upper or lower limp amputations,
- •milk/lactose allergy or intolerance,
- •hypertension >180/110,
- •pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis),
- •progressive somatic or psychiatric diseases which can affect the course of training,
- •referred to rehabilitation primarily due to gynecological and neurological conditions (apoplexies) or surgeries where movement restrictions are recommended,
- •daily medication that may have an impact on muscle protein synthesis,
- •alcohol intake greater than 14 units per week,
- •discouragement from a general practitioner.
结局指标
主要结局
Short Musculoskeletal Function Assessment (SMFA) - Dysfunction Index
时间窗: Change from: baseline to 3 months (primary endpoint) and 12 months
Self reported
次要结局
- Mean change from baseline in function measured with the 2 minutes walk test (2MWT)(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in mobility with The New Mobility Score(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in health-related quality of life on SF-36(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in the PRISMA-7 score(Change from: baseline to 3 months and 12 months)
- Measure of pain, physical activity level and educational level(Change from: baseline to 3 months and 12 months)
- Mean change from baseline of Waist-To-Hip ratio(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in the Tilburg Frailty Scale score(Change from: baseline to 3 months and 12 months)
- Measure of height at baseline(Baseline)
- Mean change from baseline in blood pressure(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in body composition measured with a bioimpedance device(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in knee extension strength(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in weight(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in resting heart rate(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in calf extension strength(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in The Borg Rating of Perceived Exertion before and after the 2 minutes walk test (2MWT)(Change from: baseline to 3 months and 12 months)
- Balance and reaction time for upper and lower extremity(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in heart rate during 2 minutes walk test (2MWT)(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in heart rate before and after the 2 minutes walk test (2MWT)(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in function measured with the Timed Up and Go test (TUG)(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in maximal isometric voluntary contraction of leg extension(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in the basic metabolic rate (BMR)(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in handgrip strength(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in leg press strength(Change from: baseline to 3 months and 12 months)
- Mean change from baseline in balance measured with the Tandem test(Change from: baseline to 3 months and 12 months)
- Protein and energy intake(Change from: baseline, week 3, week 6, week 9, 3 months and 12 months)
研究者
Sanel Teljigovic
Senior lecturer, PhD-student
University College Absalon
研究点 (2)
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