Clinical trial NCT04947787: Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System
Official title: Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Communicable Chronic Diseases
Keywords: physical activity promotion
physical activity referral scheme
physician-initiated
behaviour change
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: Changes in physical activity-related health competence: BGK Questionnaire
timeFrame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Secondary outcomes:
measure: Changes in quality of life: EuroQol (EQ-5D-5L)
timeFrame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
measure: Changes in self-efficacy towards physical activity: Selbstwirksamkeit zur sportlichen Aktivität-Skala (SSA-Scale)
timeFrame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
measure: Changes in participants' perceived autonomy support: Health Care Climate Questionnaire-Deutschland (HCCQ-D)
timeFrame: Baseline (T0), 24 weeks (T1; only intervention group)
measure: Changes in stages of change: transtheoretical model (TTM)
timeFrame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
measure: Changes in sport- and movement-related self-concordance: Sport- und bewegungsbezogenen Selbstkonkordanz Skala (SSK-Scale)
timeFrame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Other outcomes:
measure: Experience of participating actors (general practitioners, exercise professionals): (semi-) structured interviews
timeFrame: Through study completion, an average of 1 year
Locations:
city: Erlangen
country: Germany
facility: Friedrich-Alexander-University Erlangen-Nürnberg
Study officials:
affiliation: Friedrich-Alexander-University Erlangen-Nürnberg
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weissenfels A, Klamroth S, Carl J, Naber I, Mino E, Geidl W, Gelius P, Abu-Omar K, Pfeifer K. Effectiveness and implementation success of a co-produced physical activity referral scheme in Germany: study protocol of a pragmatic cluster randomised trial. BMC Public Health. 2022 Aug 13;22(1):1545. doi: 10.1186/s12889-022-13833-2.