Study on the Prevention of Weight Loss Through Physical Activity Among Nursing Home Residents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 596
- 试验地点
- 1
- 主要终点
- Changes in bodyweight
研究概览
简要总结
Appetite loss is frequent in institutionalized older adults. Physical activity is known for its benefits on appetite regulation but its effects in nursing home residents remain poorly investigated. This project will investigate the 6-month longitudinal relationships between daily physical activity time with appetite and bodyweight and how engaging in a 6-month regular exercise program can improve theses outcomes in older institutionalized older adults.
详细描述
With a prevalence that can exceed 30% in institutional settings, loss of appetite and weight loss are associated with an increased risk of mortality and adverse health conditions. Currently, no validated treatment exists to combat appetite loss. Physical activity is an effective strategy for regulating weight and appetite in adults, but its effect in older adults remains poorly established. The few studies conducted in nursing homes have not revealed a cross-sectional link between appetite and physical activity levels, nor any effect of an exercise-based intervention on appetite. However, in independent older adults, studies have shown a favorable link between physical activity levels and appetite, as well as significant effects of regular exercise programs on weight and blood markers of appetite. Thus, research on older adults is limited, and no studies have explored the longitudinal relationship between appetite and PA in institutionalized individuals, who are the most exposed to these symptoms.
The proposed study is a 6-month multicenter quasi-experimental longitudinal study divided into two parts: a longitudinal observational cohort and an interventional component. Residents included in the observational part will not receive any specific treatment but their daily physical activity levels will be assessed through accelerometers that will be worn for one week at both baseline and 6-months visits. Subjects included in the interventional part will participate in physical exercise sessions twice a week for 6 months.
The follow-up of participants will involve bodyweight measurements each month from baseline to 6 months and appetite assessment at baseline and 6 months. This study will investigate how daily physical activity time will be associated with the changes in body weight and appetite over 6 months, and how participating in a 6-month regular exercise program affect body weight and appetite compared to individuals who do not engage in such programs.
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
- None
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
- •For both the observational and interventional parts:
- •Be a resident in a nursing home (EHPAD).
- •Be affiliated with the social security system.
- •Be aged 65 years or older.
- •Have a GIR score >
- •Be able to walk 4 meters (with a walking aid if necessary, but without human assistance).
- •Provide written consent
- •For the interventional part only:
- •- Be able to understand instructions for performing the exercises.
排除标准
- •For both the observational and interventional parts:
- •Unstable cardiovascular disease or any other health condition contraindicating physical exercise.
- •End-of-life situation identified in the medical record.
- •Planned relocation to another facility during the 6-month follow-up period.
- •To be under legal protection or guardianship
研究组 & 干预措施
Interventional
Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).
干预措施: Physical activity (Other)
Interventional
Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).
干预措施: Appetite assessment (Other)
Interventional
Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).
干预措施: Food intake assessment (Other)
Interventional
Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).
干预措施: Assessment of the efficiency (Other)
Interventional
Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).
干预措施: Blood test at baseline (Biological)
Interventional
Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).
干预措施: Blood test at the end of the study (Biological)
Interventional
Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).
干预措施: Functional capacities assessment (Other)
Interventional
Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).
干预措施: weight measurment (Other)
Observational
Participants will not receive any specific care. They will simply need to wear activity trackers on two separate occasions over the course of a week: from M0 to M0 + 1 week and from M6 to M6 + 1 week.
干预措施: Appetite assessment (Other)
Observational
Participants will not receive any specific care. They will simply need to wear activity trackers on two separate occasions over the course of a week: from M0 to M0 + 1 week and from M6 to M6 + 1 week.
干预措施: Food intake assessment (Other)
Observational
Participants will not receive any specific care. They will simply need to wear activity trackers on two separate occasions over the course of a week: from M0 to M0 + 1 week and from M6 to M6 + 1 week.
干预措施: Assessment of the efficiency (Other)
Observational
Participants will not receive any specific care. They will simply need to wear activity trackers on two separate occasions over the course of a week: from M0 to M0 + 1 week and from M6 to M6 + 1 week.
干预措施: Blood test at baseline (Biological)
Observational
Participants will not receive any specific care. They will simply need to wear activity trackers on two separate occasions over the course of a week: from M0 to M0 + 1 week and from M6 to M6 + 1 week.
干预措施: Functional capacities assessment (Other)
Observational
Participants will not receive any specific care. They will simply need to wear activity trackers on two separate occasions over the course of a week: from M0 to M0 + 1 week and from M6 to M6 + 1 week.
干预措施: weight measurment (Other)
结局指标
主要结局
Changes in bodyweight
时间窗: 6 months
It will be assessed by measuring the bodyweight (kg) seven times (initially and once a month). For the observational arm, it will be measured based on daily physical activity (min/day) as measured by activity trackers. For the interventional arm, it will be measured based on participation in the physical activity program (ratio of sessions attended to sessions scheduled) over a 6-months period.
次要结局
- Changes in the score of the SNAQ questionnaire(6 months)
- Changes in the nutrition evaluation(6 months)
- Patients' healthcare consumption(6 months)
- Efficiency of the physical exercise program assessed using costs from the community's perspective and QALYs(6 months)
- Baseline blood concentrations of leptin, insulin, and GDF-15 at the inclusion(On inclusion)
- Changes in blood concentrations of leptin, GDF-15, and insulin(6 months)
- Evolution of cognition(6 months)
- Evolution of nutrition(6 months)
- Evolution of hearing(6 months)
- Evolution of vision(6 months)
- Evolution of mobility: physical performances(6 months)
- Evolution of mobility: muscular strenght(6 months)
- Evolution of mood: Depressive symptoms(6 months)
- Evolution of mood: Sadness symptoms(6 months)
- Measuring blood biomarkers of neurodegeneration and establishment of a biobank for the measurement of new aging biomarkers(6 months)