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

NCT04947787 | Completed

• 1 other identifier: BewegtVersorgt
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Communicable Chronic Diseases

Keywords

physical activity promotion; physical activity referral scheme; physician-initiated; behaviour change

Outcome Measures

Primary Outcomes (2)

• Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire

  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.

  Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

• Changes in physical activity-related health competence: BGK Questionnaire

  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.

  Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Secondary Outcomes (5)

• Changes in quality of life: EuroQol (EQ-5D-5L)

  Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

• 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 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)

Other Outcomes (1)

• Experience of participating actors (general practitioners, exercise professionals): (semi-) structured interviews

  Through study completion, an average of 1 year

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants receive a physical activity referral scheme.

Behavioral: Physical activity referral scheme (PARS)

Control Group

ACTIVE COMPARATOR

Participants receive physical activity advice from general practitioners.

Behavioral: Physical activity advice (PAA)

Interventions

Physical activity referral scheme (PARS) BEHAVIORAL

Participants of the intervention group will receive brief physician advice and be referred to an exercise professional (e.g., physiotherapist, sports therapist) for a more intensive counseling intervention. The counseling intervention consists of an initial assessment, individual physical activity counseling (360'), a final assessment after 12 weeks, and a follow-up assessment after 24 weeks.

Intervention Group

Physical activity advice (PAA) BEHAVIORAL

Participants of the control group will only receive brief physician advice regarding the promotion of physical activity and as an information sheet with tips on how to adopt a more physically active lifestyle.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead

Study Sites (1)

Friedrich-Alexander-University Erlangen-Nürnberg

Erlangen, 91058, Germany

Location

Related Publications (2)

• Klamroth S, Mino E, Naber I, Weissenfels A, Geidl W, Gelius P, Abu-Omar K, Pfeifer K. Coproducing a physical activity referral scheme in Germany: a qualitative analysis of stakeholder experiences. BMJ Open. 2024 May 22;14(5):e082710. doi: 10.1136/bmjopen-2023-082710.

  PMID: 38777585 DERIVED

• 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.

  PMID: 35964042 DERIVED

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Klaus Pfeifer, Prof. Dr.

  Friedrich-Alexander-University Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Sport Science and Sport

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 1, 2021
• Study Start: February 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DE (1)