Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the … (NCT04947787) | Clinical Trial Compass
CompletedNot Applicable
Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System
Germany168 participantsStarted 2022-02-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire
Timeframe: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
2
Changes in physical activity-related health competence: BGK Questionnaire
Timeframe: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)