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

NCT ID: NCT04947787

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

552 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Communicable Chronic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

Participants receive a physical activity referral scheme.

Group Type EXPERIMENTAL

Physical activity referral scheme (PARS)

Intervention Type 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.

Control Group

Participants receive physical activity advice from general practitioners.

Group Type ACTIVE_COMPARATOR

Physical activity advice (PAA)

Intervention Type 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.

Interventions

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Physical activity referral scheme (PARS)

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 Type BEHAVIORAL

Physical activity advice (PAA)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Klaus Pfeifer

Head of the Department of Sport Science and Sport

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Pfeifer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Friedrich-Alexander-University Erlangen-Nürnberg

Locations

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Friedrich-Alexander-University Erlangen-Nürnberg

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Anja Weissenfels, Dr.

Role: CONTACT

+4991318528182

Sarah Klamroth, Dr.

Role: CONTACT

+4991318528182

Facility Contacts

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Klaus Pfeifer, Prof. Dr.

Role: primary

+49 9131 8525465

References

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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.

Reference Type DERIVED
PMID: 38777585 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35964042 (View on PubMed)

Other Identifiers

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BewegtVersorgt

Identifier Type: -

Identifier Source: org_study_id

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