Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 552
- 试验地点
- 2
- 主要终点
- Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire
研究概览
简要总结
The BewegtVersorgt project involved co-producing a physical activity referral scheme (PARS) for inactive persons with underlying non-communicable diseases. Various relevant actors of the German healthcare system (e.g., representatives of physicians, health insurance providers, sports organizations, exercise representatives of exercise professions, representatives of patients) participated in the co-production process.
The purpose of this study is to evaluate the effectiveness of co-produced PARS in the Erlangen-Nuremberg-Fürth region. Local general practitioners and exercise professionals will carry out the implementation of the PARS in standard care. The cluster-randomized study includes two intervention arms; one group will receive specific support from physical activity experts to increase physical activity (PARS). The control group will receive only the physician's advice and then continue to engage in physical activity on their own (PAA). The participants will be followed up at 12 and 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older; living in the region of Erlangen-Nürnberg-Fürth, Germany;
- •At least one of the following existing non-communicable diseases (controlled type 2 diabetes mellitus; cardiovascular diseases; obesity (BMI ≥ 30 kg/m2); arthrosis in knee and/or hip);
- •Not meeting German PA recommendations (less than 150 minutes/week of moderate-intensity aerobic activity or less than 75 minutes/week of vigorous-intensity aerobic activity or any other equivalent combination);
- •The person can safely participate in physical activities based on general practitioners' clinical judgment.
排除标准
- •The person plans to leave the region of Erlangen-Nürnberg-Fürth during the study period;
- •The person participating in another study with similar content;
- •The person is or plans to be absent for more than four weeks during the 12-week-intervention period;
- •Person has cognitive impairments that prevent an effective communication with the general practitioner and the therapist;
- •Persons with mental illness such as psychotic, substance abuse, mood, personality disorders;
- •Unstable clinical situation or serious health impairments that prevent from undertaking physical activity safely (e.g., acute myocardial infarction, unstable angina pectoris, fever, terminal tumor diseases
结局指标
主要结局
Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire
时间窗: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
The Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen; BSA-F) is a German questionnaire that assesses the amount of physical activity during the last four weeks. It differentiates between leisure-time/transportation activities (physical activity score) and sport-/exercise-related activities (sports score). Participants are required to report the frequency and duration of activities executed during the last four weeks. Minutes of leisure-time physical activity per week and sport-/exercise-related activity per week are calculated to get the physical activity and the sports score. Both scores can be combined to receive the overall volume of physical activity completed during leisure-time/transportation and sport-/exercise-related activities.
Changes in physical activity-related health competence: BGK Questionnaire
时间窗: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
This will be measured by the German version of the Physical Activity-Related Health Competence questionnaire. The questionnaire consists of 44 total items that measure three sub-competencies necessary for a health-promoting physical activity behavior: movement competence (20 items; min = 0, max = 17.6), control competence (10 items; min = 0, max = 10.8), physical activity-related self-regulation competence (14 items; min = 0, max = 14.8). Higher scores indicate higher competencies.
次要结局
- Changes in self-efficacy towards physical activity: Selbstwirksamkeit zur sportlichen Aktivität-Skala (SSA-Scale)(Baseline (T0), 12 weeks (T1), and 24 weeks (T2))
- Changes in quality of life: EuroQol (EQ-5D-5L)(Baseline (T0), 12 weeks (T1), and 24 weeks (T2))
- Changes in participants' perceived autonomy support: Health Care Climate Questionnaire-Deutschland (HCCQ-D)(Baseline (T0), 24 weeks (T1; only intervention group))
- Changes in stages of change: transtheoretical model (TTM)(Baseline (T0), 12 weeks (T1), and 24 weeks (T2))
- Changes in sport- and movement-related self-concordance: Sport- und bewegungsbezogenen Selbstkonkordanz Skala (SSK-Scale)(Baseline (T0), 12 weeks (T1), and 24 weeks (T2))
研究者
Prof. Dr. Klaus Pfeifer
Head of the Department of Sport Science and Sport
University of Erlangen-Nürnberg