Cost-Effectiveness of an Exercise Program in Midlife Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The Incremental Cost Effectiveness Ratio (ICER)
研究概览
简要总结
Spain is the second country in the world that consume more drugs. The average drug expenditure per capita in Andalucía during 2011 was 219.2 €. This drug spending increases during the perimenopausal period. According to the Study of the Economic Impact of Sport on Health Spending of the Ministry of Health of the Generalitat of Catalonia, for every euro invested in sports promotion 50 euros are saved in health spending accumulated over 15 years. The main objectives of this project are: i) To analyze the (cost-effectiveness) effect of an exercise program on the prescription of drugs in a sample of Andalusian women aged 45-60 years. ii ) To study the level of physical activity and sedentarism (measured objectively by accelerometry ) , functional capacity , quality of life and clinical profile of this population. iii ) To analyze the relationship between levels of physical activity / sedentarism and pharmaceutical expenditure. In the present project, an exercise program aimed at minimizing symptoms and health problems associated with the perimenopausal period will be performed (Dyslipidemia, diabetes, anxiety, depression, quality of life, quality of sleep, obesity, osteoporosis and cardiovascular disease). A total of 160 perimenopausal women will be randomly assigned to the intervention group exercise (n = 80 ) or to the usual care group (n = 80). Participants in the intervention group will train 3 days / week ( 60 min per session ) for 16 weeks.
With the analysis of the results of this project new patterns of objective work as well as the most significant practical resources for the design of a master plan may be determined. Results are expected to be able to shed some light on the implementation of programs of health promotion that are both time beneficial for the Andalusian Public Health and for the family , institutional and community economy.
详细描述
Spain is the second country in the world that consumes more drugs. The average drug expenditure per capita in Andalucía during 2011 was 219.2 €. This drug spending increases during the perimenopausal period. According to the Study of the Economic Impact of Sport on Health Spending of the Ministry of Health of the Generalitat of Catalonia, for every euro invested in sports promotion 50 euros are saved in health spending accumulated over 15 years. The main objectives of this project are: i) To analyze the (cost-effectiveness) effect of an exercise program on the prescription of drugs in a sample of Andalusian women aged 45-60 years. ii ) To study the level of physical activity and sedentarism (measured objectively by accelerometry ) , functional capacity , quality of life and clinical profile of this population. iii ) To analyze the relationship between levels of physical activity / sedentarism and pharmaceutical expenditure. In the present project, an exercise program aimed at minimizing symptoms and health problems associated with the perimenopausal period will be performed (Dyslipidemia, diabetes, anxiety, depression, quality of life, quality of sleep, obesity, osteoporosis and cardiovascular disease). A total of 160 perimenopausal women will be randomly assigned to the intervention group exercise (n = 80 ) or to the usual care group (n = 80). Participants in the intervention group will train 3 days / week ( 60 min per session ) for 16 weeks.
With the analysis of the results of this project new patterns of objective work as well as the most significant practical resources for the design of a master plan may be determined. Results are expected to be able to shed some light on the implementation of programs of health promotion that are both time beneficial for the Andalusian Public Health and for the family , institutional and community economy.
The present study is a Randomized Controlled Trial (RCT). The study protocols were approved by the Ethics Committee for Research Involving Human Subjects at the University of Granada. All participants have to provide a written informed consent. After baseline measurements, they will be randomly allocated to the usual care (control) or exercise intervention group. The participants will be followed for 16 weeks during the training interventions. All the baseline and follow-up examinations will be performed in the same setting (two primary care health centers) and by the same researchers. The study will follow the ethical guidelines of the Declaration of Helsinki (last modified in 2013).
Participants at the control group will receive general advices about the positive effects of physical activity by pamphlets describing the benefits their benefits and general guidelines about how to increase the daily physical activity levels.
The exercise intervention will be performed in groups of 20 participants. Each group will train 3 days/week (60 min per session) for a 16-week period. It will meet the minimum training standards of the American College of Sports Medicine(Garber, Blissmer et al. 2011). Each exercise session will be designed and supervised by exercise monitors and will include a 15 minute warm-up period followed by 35 minute focused mainly on aerobic exercises, developed progressively and resistance strength training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 45-60 years.
- •Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer "no" to all questions on the Physical Activity Readiness Questionnaire-PAR-Q) .
- •Not to be engaged in regular physical activity >20 min on >3 days/week.
- •Able to ambulate, with or without assistance.
- •Able to communicate.
- •Informed consent: Must be capable and willing to provide consent.
排除标准
- •Acute or terminal illness.
- •Myocardial infarction in the past 3 months.
- •Not capable to ambulate.
- •Unstable cardiovascular disease or other medical condition.
- •Upper or lower extremity fracture in the past 3 months.
- •Severe dementia (MMSE < 10).
- •Unwillingness to either complete the study requirements or to be randomised into control or training group.
- •Presence of neuromuscular disease or drugs affecting neuromuscular function.
结局指标
主要结局
The Incremental Cost Effectiveness Ratio (ICER)
时间窗: 16 weeks
It is calculated dividing the difference between the average costs of both groups by the difference in mean QALYs gained in both groups.
次要结局
- Quality Adjusted Life Years (QALYs)(16 weeks)
研究者
Virginia A. Aparicio García-Molina
PhD Sport Sciences, PhD Nutrition and Food Technology
Universidad de Granada
