Prevention Study on Loss of Autonomy and Physical Dependence, Based on Physical Exercises and Nutrition Counseling Applied to Old People.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Functional status
研究概览
简要总结
According to several reports, the proportion of people aged 80yrs or older will be doubled within the next 25y, reaching 10% of the global population. Furthermore, the health life expectancy at 65y is 10.4y which remains much lower than the general life expectancy. As a result, there is a constant need of developing preventive strategies through multimodal programs.
Among the predictive factors of mobility disability with age, muscular weakness and decreased physical function are major components. These two factors are known of being responsible for falls and fractures that lead to decrease the quality of life and an increase in mortality.
Exercise and nutrition are the only components that have proven their efficacy to struggle mobility disability risk. It is important to integrate these two components in a sustained intervention within a multidimensional prevention program. However, there is a lack of implementation of these programs in primary care.
Indeed, neither the screening of older adults at risk of mobility disability, nor the preventive actions are usually implemented for this population. The implementation of a prevention care pathway, with personalized intervention and a sustained follow-up, along with supervised exercise training combined with nutritional counselling, is the public health imperatives.
Based on prevention care pathway that designed for community-dwelling older adults screened at risk of mobility disability. The purpose of this open cohort study was to highlight the efficacy and the feasibility of a multimodal program implemented on real-life setting specifically on the physical function and risk of mobility loss, along with their maintenance at 6-months and 1-year follow-up.
详细描述
Two groups will be identified :
A first group with a SPPB (Short physical performance battery) score between 8 and 10 and walking more than 90 minutes per week. They will be asked to carry out 2 to 3 times a week a series of exercises concerning the main muscle groups, using bodyweight, and without specific equipment. An activity booklet will be given as support. In a complementary way, individual objectives will be established to develop endurance by fighting against hyper-sedentariness based on simple advice to the patient and his entourage. The volume of physical activity will be developed from activities of daily living. A telephone coaching will be carried out every 4 weeks by a Adapted Physical Activity Monitor and a precise evaluation of the physical performances will be carried out at 3 months.
A second group for patients with Short physical performance battery ≤ 8 or if >8 but excessive sedentary walking less than 90 minutes per week, including running, or having sarcopenia criteria.
They will be offered bi-weekly care by a Adapted Physical Activity Monitor. Training will be conducted either in small group programs or at home (if unable to attend), at the frequency of 2 sessions per week for 10 weeks. The personalized program of muscular reinforcement will be of progressive intensity with and without additional load and with very simple and easily usable devices including at home (elastic bands, weights. . . ).
During the dedicated geriatric consultation, the nutritional status will also be evaluated by a food survey and biological samples in order to measure the usual serum nutritional markers. The objective of the assessment is to ensure an adequate intake of macro nutrients, including proteins, and energy; as well as micronutrient fruits and vegetables rich in antioxidants and omega 3 fatty acids which also have a significant impact in terms of prevention and muscle function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligible for the "mobility loss prevention" program
- •At least one of the following signs:
- •Difficulty carrying a loaded shopping basket (about 4.5 kg)
- •Difficulty rising from a chair without using the arms
- •Difficulty climbing one flight of stairs (10 steps)
- •Difficulty moving around
- •Slowed walking
- •Difficulty walking more than 400 meters without stopping
- •Walking time < 30 minutes/day
- •Fatigue during mild physical efforts: running errands, household chores; fear of falling and/or at least one fall in the past year
- •Recent unintentional weight loss: weight loss ≥ 5% in 6 months or BMI < 22 kg/m²
排除标准
- •Patient who has not given consent to participate
- •Patient under guardianship in retrospective phase
- •Locomotor disability
- •expectancy of life being under 12 months
- •BMI ≥ 35 Kg/m2
研究组 & 干预措施
Multicomponent group-based supervised exercise program
Community-dwelling older adults aged of >70y, screened at risk of mobility disability risk factors and assessed with at least 1 mobility disability risk factor (see intervention 1). These subjects are included in the protocol and participate in a multicomponent exercise program.
干预措施: Multidimensional assessments (Diagnostic Test)
Multicomponent group-based supervised exercise program
Community-dwelling older adults aged of >70y, screened at risk of mobility disability risk factors and assessed with at least 1 mobility disability risk factor (see intervention 1). These subjects are included in the protocol and participate in a multicomponent exercise program.
干预措施: Multicomponent group-based and supervised exercise program (Other)
Multicomponent group-based supervised exercise program
Community-dwelling older adults aged of >70y, screened at risk of mobility disability risk factors and assessed with at least 1 mobility disability risk factor (see intervention 1). These subjects are included in the protocol and participate in a multicomponent exercise program.
干预措施: Follow-up at T3 + 6 months and T3 + 12 months (Other)
结局指标
主要结局
Functional status
时间窗: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Functional status is assessed using the overall SPPB (Short Physical Performance Battery) score based on three components: 6 meters usual walking speed, 5 repetitions chair stand test, and static balance tests. (composite score /12). The SPPB score is calculate from the results in 3 subtests. It ranges from 1 to 12 points. Clinically meaningful change is 1 point.
Functional status
时间窗: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Functional status is assessed using the overall SPPB (Short Physical Performance Battery) score based on three components: 6 meters usual walking speed, 5 repetitions chair stand test, and static balance tests. (composite score /12). The SPPB score is calculate from the results in 3 subtests. It ranges from 1 to 12 points. Clinically meaningful change is 1 point.
次要结局
- Evaluation of effectiveness on muscle strength : Handgrip test (kg)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of effectiveness on muscle strength : Maximal isometric strength of the quadriceps (kg)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of effectiveness on functional status : 5 repetitions chair stand test (s)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of effectiveness on functional status : Time in TUG (s)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of effectiveness on functional status : Lower body muscle power measured by a one sit-to-stand test perform at maximum speed (Neurocom Balance Master, Medimex®, France)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of effectiveness on functional status : Gait quality analysis using inertial sensors (GaitUp, MindMaze®, Switzerland)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of muscle mass : SMI measured by bio-impedance analysis (kg.m2)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of muscle mass : Ultrasonography of the vastus lateralis(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of dependencies : Katz scale (Activities of Daily Living - ADL)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of dependencies : Lawton scale (Instrumental Activities of Daily Living-IADL)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Record of undesirable events : Falls, unscheduled hospitalization, illness, institutionalization(initial assessment (baseline), following the exercise program (month 3), 6 months following the exercise program (month 9), last visit (month 15))
- Evaluation of fear of falling : FES-I questionnaire (/64)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evolution of the level of physical activity : RAPA questionnaire (/10)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evolution of quality of life : SarQoL© questionnaire(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of biomarkers : risk of fractures - Calcemia (mmol/L)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of biomarkers : risk of fractures - Vitamin D (nmol/L).(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of biomarkers : exploratory Fibroblast Growth Factor 19 (FGF-19) (pg/L)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of biomarkers : nutritional status - Albumin (g/L)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of biomarkers : nutritional status - Pre-albumin (g/L)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of biomarkers : inflammation C-reactive protein(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of physical frailty : Fried criteria(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of sarcopenia : EWGSOP2(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of nutritional status : Mini Nutritional Assessment(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of nutritional status : caloric (kcal) needs and intakes from the dietary survey(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of nutritional status : protein (g/J) needs and intakes from the dietary survey(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of sarcopenia : EWGSOP2(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of nutritional status : Mini Nutritional Assessment(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of nutritional status : caloric (kcal) needs and intakes from the dietary survey(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of effectiveness on muscle strength : Maximal isometric strength of the quadriceps (kg)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of effectiveness on functional status : 5 repetitions chair stand test (s)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of effectiveness on functional status : Time in TUG (s)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of effectiveness on functional status : Lower body muscle power measured by a one sit-to-stand test perform at maximum speed (Neurocom Balance Master, Medimex®, France)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of muscle mass : Ultrasonography of the vastus lateralis(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of effectiveness on muscle strength : Handgrip test (kg)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of muscle mass : SMI measured by bio-impedance analysis (kg.m2)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of dependencies : Katz scale (Activities of Daily Living - ADL)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of effectiveness on functional status : Gait quality analysis using inertial sensors (GaitUp, MindMaze®, Switzerland)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of fear of falling : FES-I questionnaire (/64)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evolution of the level of physical activity : RAPA questionnaire (/10)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of biomarkers : risk of fractures - Vitamin D (nmol/L).(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of dependencies : Lawton scale (Instrumental Activities of Daily Living-IADL)(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Record of undesirable events : Falls, unscheduled hospitalization, illness, institutionalization(initial assessment (baseline), following the exercise program (month 3), 6 months following the exercise program (month 9), last visit (month 15))
- Evolution of quality of life : SarQoL© questionnaire(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of biomarkers : risk of fractures - Calcemia (mmol/L)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of biomarkers : exploratory Fibroblast Growth Factor 19 (FGF-19) (pg/L)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of biomarkers : nutritional status - Albumin (g/L)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of biomarkers : nutritional status - Pre-albumin (g/L)(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of physical frailty : Fried criteria(initial assessment (baseline), following the exercise program (month 3), last visit (month 15))
- Evaluation of biomarkers : inflammation C-reactive protein(initial assessment (baseline), following the exercise program (month 3))
- Evaluation of nutritional status : protein (g/J) needs and intakes from the dietary survey(initial assessment (baseline), following the exercise program (month 3))