ProMIO 2.0; A Powerful Lifestyle Intervention for Older Adults From Ethnic Minorities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Physical functioning
研究概览
简要总结
Older adults from ethnic minorities show on average a worse disease risk profile compared to the majority populations. An important risk factor to develop chronic diseases is the loss of muscle mass and functioning, also known as sarcopenia. Several randomized controlled trials (RCTs) showed that the combination of adequate protein intake and physical exercise is most effective to prevent the loss of muscle mass, strength and functioning in older adults. However, until shortly, no intervention that included protein and exercise was available that accounted for the special socio-cultural needs of ethnic minority populations. Therefore the Amsterdam University of Applied Sciences (AUAS) and ProMIO project group developed a cultural sensitive lifestyle intervention with protein and exercise carried out by dieticians and physical therapists to provide a tailored treatment for older adults from ethnic minorities. This project aims to evaluate the effectiveness of this new intervention on protein intake, physical activity behavior, muscle mass, muscle strength, function and quality of life. The cost-effectiveness of this new intervention will also be evaluated.
详细描述
Primary Objective: To investigate the effectiveness of the ProMIO lifestyle intervention (targeting protein intake and exercise behavior) on physical functioning, in older adults from ethnic minorities (Surinamese).
The intervention will be a lifestyle intervention targeted at changing health behaviors in older adults from ethnic minorities in the Netherlands. Methods will be used that target specific behavioral determinants in order to optimize both exercise and dietary behavior. We aim to reach the following behavioral outcomes:
-
1.2g/kg BW/day (~25 - 30 grams of protein per meal (4x/day))
-
Reaching the WHO physical activity guidelines for older adults:
-
At least 150-300 minutes/week moderate-intensity aerobic physical activity (such as walking)
-
2x/week strength, balance and functional exercises
Based on previous research it is expected that by optimizing these health behaviors, muscle mass, muscle strength, and physical functioning will improve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born in Surinam (or at least one of the parents was born there)
- •Aged ≥55 years
- •Physical ability and willingness to execute an MCE program
- •Ability and willingness to comply with the study protocol
- •Written informed consent
- •Consent of the study physician
排除标准
- •Aged <55 years
- •Diagnosed with renal insufficiency (MDRD<30, GP approved)
- •Suffering from physical disabilities causing the inability to perform the main exercises (walking aids or mild visual impairment are not an exclusion criteria)
- •Diagnosed unstable coronary heart disease (CHD), decompensated heart failure, or uncontrolled arrhythmias
- •End stage Chronic Obstructive Pulmonary Disease (COPD) GOLD >3
- •Phase IV cancer
- •Diagnosed degenerative neurocognitive disorders
- •Active (para-)medical treatment interfering with this intervention
- •Current enrolment in a fixed rehabilitation program or other intervention studies
- •Palliative treatment or a life expectancy of ≤3 months
- •A trip >2 weeks planned in first three months of study or >2 months during the rest of the intervention period
结局指标
主要结局
Physical functioning
时间窗: baseline, 6 months
change in meters from baseline to 6 months by 6 Minute Walk Test
次要结局
- Balance (Single Leg Stand Test)(baseline, 3 months, 6 months)
- Body composition BMI(baseline, 3 months, 6 months)
- Quality of Life (QoL)(baseline, 3 months, 6 months)
- Frailty(baseline, 3 months, 6 months)
- Body composition Weight(baseline, 3 months, 6 months)
- Body composition Lenght(baseline, 3 months, 6 months)
- Strenght with Hand Grip Strenght(baseline, 3 months, 6 months)
- Body composition 2D muscle echo(baseline, 3 months, 6 months)
- Activities of Daily Living (ADL) Katz(baseline, 3 months, 6 months)
- Behavioral outcome - Dietary intake (48h recall)(baseline, 3 months, 6 months)
- Sarcopenia screening (SarQoL)(baseline, 3 months, 6 months)
- Risk of Falls (NRS)(baseline, 3 months, 6 months)
- Efficacy Scale International (sFES-I)(baseline, 3 months, 6 months)
- symptoms of depression (CES-D)(baseline, 3 months, 6 months)
- Cost effectiveness - Productivity Cost Questionnaire (PCQ)(baseline, 6 months)
- Cost effectiveness - Cost of Quality (MCQ)(baseline, 6 months)
- Adverse events(During study)
- Sleep (NRS)(baseline, 3 months, 6 months)
- Medication use(screening and during study)
- Adherence to the intervention(During study)
- 30-sec Chair Stand Test(baseline, 3 months, 6 months)
- Strenght (1RM with Microfet)(baseline, 3 months, 6 months)
- Behavioral outcome - Physical Activity(baseline, 3 months, 6 months)
- Pain (NRS)(baseline, 3 months, 6 months)
- Process evaluation(6 months)
- Social democrafic characteristics(screening, baseline)
- Medical history(screening)