Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System (BewegtVersorgt)

University of Erlangen-Nürnberg

Status: Enrolling

Conditions: Non-Communicable Chronic Diseases

Treatments: Behavioral: Physical activity advice (PAA); Behavioral: Physical activity referral scheme (PARS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04947787

BewegtVersorgt

Details and patient eligibility

About

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.

Enrollment: 552 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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552 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Participants receive a physical activity referral scheme.

Treatment:

Behavioral: Physical activity referral scheme (PARS)

Control Group

Active Comparator group

Description:

Participants receive physical activity advice from general practitioners.

Treatment:

Behavioral: Physical activity advice (PAA)