Study of the Determinants Associated With Sustained Changes in Physical Activity Behaviors, and Their Effects on the Prevention and Treatment of Chronic Diseases, in Individuals Enrolled in an Adapted Physical Activity Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,024
- 试验地点
- 2
- 主要终点
- 5-year persistence of a positive trajectory of active behavior
研究概览
简要总结
Introduction: Regular practice of exercise or physical activity (PA) is a recognized intervention as a determinant of good health acquisition, maintenance, or recovery for a large number of chronic pathologies. Nevertheless, few studies have evaluated adherence to an initial health-adapted PA (APA) program, and persistence of active behavior over the time in individuals with a chronic disease.
The aim of the study is to determine the brakes and levers associated with motivation and long-term compliance. In addition, the investigators aim to evaluate the cost-effectiveness of such program in term of care consumption. Finally, the investigators complete their interest for APA prescription from practitioners agreeing to enroll their patients in the present study.
Method: The investigators perform a prospective monocentric cohort, of 2024 patients affected of a chronic disease or long-term illness (LTI), enrolled from 2021 to 2024 (4 years, 506 per year), for a 16-week APA program, and followed 5 years with an annual fitness and habits of life and care consumption evaluation.
详细描述
Background:
While physical inactivity is the first modifiable risk factor (2nd is tobacco consumption) for cardiovascular morbidity and mortality and cancer in the World, regular physical activity (PA) is a recognized intervention with a high level of evidence, as a key determinant of good health acquisition, maintenance, or recovery for a large number of chronic pathologies.
The following 3 points caught the investigators' interest:
Point n°1: The 2019 collective expertise of the French National Institute of Health and Medical Research (INSERM) "Physical Activity: Prevention and Treatment of Chronic Diseases" reported following findings on the motivational aspects of regular or non-regular PA practice by people suffering from a chronic disease: 1) people with chronic disease practice less than the general population of the same age; 2) a significant number of patients do not participate in the proposed PA programs, and high drop-out rates are reported during these programs; 3) only a small percentage of patients maintain PA after completion of these programs. However, there is a lack of evidence and inconsistent quality studies regarding changes in duration of behavior following PA intervention programs. Follow-up of behavioral changes beyond 2 years is extremely rare in the literature. Thus, the problem is of a behavioral nature: on one hand, whether or not a person with a chronic disease adheres to an initial health-adapted PA program (APA), and on the other hand, whether or not a PA practice persists or is maintained over time. The identification of barriers and levers is key to help define actionable means to support adherence and enhance the sustainability of the virtuous behavior change induced by an initial program. This need for studies is underlined by "The group of experts [from INSERM, which] recommends: 1) long-term intervention studies with supervised exercises and 2) long-term post-intervention follow-up in order to better evaluate the continuation of program practice in autonomy", but also "to promote research on motivation and long-term compliance".
Point n°2: In relation to the benefit of PA programs on the physical and psycho-social fitness of individuals, the effects on health are demonstrated. As a result, a decrease in the prevalence of health events and their complications can be observed, as well as a more detailed use of care (drug treatment, consultations, and hospitalizations) depending on whether or not the participant benefits from an APA intervention. The medico-economic impact of such APA intervention has been little studied. Thus, the problem is of a medico-economic nature: the interest will initially focus on the evolution of care pathways over time, and the differences observed according to pathologies, but also according to the participants' behavior, in terms of compliance, or persistence or not in the duration of the favorable change in behavior initially acquired. An evaluation of care consumption and care pathways according to whether individuals have benefited from an APA program as proposed (SESAME cohort) or not (controls) also appears justified and will come later. This need for studies is emphasized by the INSERM expert group, which recommends "evaluating the cost-effectiveness of interventions according to the technique(s) used".
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
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •18 years of age or older
- •Speaking and understanding French
- •Affected by a chronic pathology according to a predefined list (LTI, obesity, HTA, COPD, COVID-19 with persistent symptoms)
- •Carrier of a writing APA prescription
- •Able to come to "Mon Stade" twice a week for their APA sessions following the 16-week health-adapted PA program;
- •Signature of the information and consent form.
排除标准
- •Women whose pregnancy is known
结局指标
主要结局
5-year persistence of a positive trajectory of active behavior
时间窗: 5 years
Study of the brakes and levers associated with the persistence at 5 years of an initial 16-week APA program, of a positive trajectory of the percentages of "moderate to vigorous" AP practice collected by wearing for 7 days a wGT3X-BT type accelerometer (Actigraph, Pensacola, FL, USA), illustrating the persistence of the favorable change in behavior eventually induced
次要结局
- Behavioral analysis: Lifestyle habits: Accelerometer: Time in sitting, standing or lying down(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Lifestyle habits: Accelerometer: Number of steps(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Lifestyle habits: Global Physical Activity Questionnaire "GPAQ"(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Lifestyle habits: "Ricci & Gagnon" vs. GPAQ(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Quality of life, psychological determinants: Eating habits(End of the APA program (between 4 and 9 months), 5 years)
- Behavioral analysis: Quality of life, psychological determinants: Alcohol consumption(End of the APA program (between 4 and 9 months), 5 years)
- Behavioral analysis: Parameters associated with good adherence to the initial APA program(End of the APA program (between 4 and 9 months))
- Behavioral analysis: Quality of life, psychological determinants: WHOQOL-BREF(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Quality of life, psychological determinants: EMAPS(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Medico-Economic Analysis: Budget impact analysis(1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Lifestyle habits: "Ricci & Gagnon"(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Quality of life, psychological determinants: POMS(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Lifestyle habits: Accelerometer: Daily sedentary time(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Lifestyle habits: Accelerometer: Average daily energy expenditure (KCal)(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Lifestyle habits: "Ricci & Gagnon" vs. Accelerometer(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Quality of life, psychological determinants: Sleep(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Behavioral analysis: Parameters associated with persistence of physical activity practice over time(1 year, 2 years, 3 years, 4 years)
- Analysis of APA prescription:(During the 4 years of participants' inclusion for the study)
- Behavioral analysis: Quality of life, psychological determinants: QBAP(End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years)
- Medico-Economic Analysis: Care consumption(1 year, 2 years, 3 years, 4 years, 5 years)
- Medico-Economic Analysis: Cost of the APA program: Direct costs(1 year, 2 years, 3 years, 4 years, 5 years)
- Medico-Economic Analysis: Cost of the APA program: Indirect costs(1 year, 2 years, 3 years, 4 years, 5 years)
