Non-Communicable Chronic DiseasesBewegtVersorgtNCT04947787
Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System
A study testing Physical activity referral scheme (PARS) and Physical activity advice (PAA) in people with Non-Communicable Chronic Diseases, run by University of Erlangen-Nürnberg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Communicable Chronic Diseases
- What is being tested?
- Physical activity referral scheme (PARS) and Physical activity advice (PAA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Alexander-University Erlangen-Nürnberg
Erlangen, 91058
About this study
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
- Being tested
- Physical activity referral scheme (PARS), Physical activity advice (PAA)
- Keywords
- physical activity promotion, physical activity referral scheme, physician-initiated, behaviour change
- Medical subject headings
- Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity referral scheme (PARS)Behavioural
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.
Physical activity advice (PAA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive a physical activity referral scheme. Receives: Behavioral: Physical activity referral scheme (PARS) |
| Control Group | Active comparator | Participants receive physical activity advice from general practitioners. Receives: Behavioral: Physical activity advice (PAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Secondary outcomes (5)
Changes in quality of life: EuroQol (EQ-5D-5L)
The EQ-5D-5L is a self-administered quality of life scale that consists of a descriptive system and a visual analog scale. The descriptive system contains five well-being dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems), each coded with numbers from one to five. The result obtained is a 5-digit code that represents the health state profile of the participant. The visual analog scale assesses the overall current health.
Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in self-efficacy towards physical activity: Selbstwirksamkeit zur sportlichen Aktivität-Skala (SSA-Scale)
This will be measured by a German instrument (Selbstwirksamkeit zur sportlichen Aktivität; SSA-Scale), including 12 items that assess the confidence someone has to perform a planned physical activity in the face of various conditions that may act as barriers. Each item is scored on a seven-point Likert scale representing the level of confidence from '1' meaning not sure at all and '7' meaning the participant is very confident of performing the physical activity as planned even in the face of a particular challenge. The total scores range from 12 to 84, where the higher the score, the greater the self-efficacy.
Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in participants' perceived autonomy support: Health Care Climate Questionnaire-Deutschland (HCCQ-D)
We will use the German version of the Health Care Climate Questionnaire (HCCQ-D) to measure the participant's perception of autonomy support from the general practitioner. It incorporates 15 statements with seven-point response options that indicate the level of agreement ranging from strongly disagree to strongly agree. Higher scores indicate higher perceived autonomy support.
Measured: Baseline (T0), 24 weeks (T1; only intervention group)
Changes in stages of change: transtheoretical model (TTM)
We will use one German question that is based on the transtheoretical model of behavior change. The five response options represent five stages of change: pre-contemplation, contemplation, preparation, action, and maintenance.
Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in sport- and movement-related self-concordance: Sport- und bewegungsbezogenen Selbstkonkordanz Skala (SSK-Scale)
This will be evaluated with the self-administered German scale (Sport- und bewegungsbezogenen Selbstkonkordanz-Skala; SSK-Scale) that measures the self-concordance. The SSK-Scale contains 12 items grouped into four subscales: intrinsic, identified, introjected, and extrinsic motivation. The subscales' scores for introjected and extrinsic motivation will be subtracted from the sum of the identified and intrinsic motivation subscales to receive the overall score. Thus, the overall score ranges from minus ten (-10) to ten, where a higher score suggests a higher level of sports- and movement-related self-concordance.
Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Communicable Chronic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
- Investigators
- Klaus Pfeifer, Prof. Dr., Principal investigator, Friedrich-Alexander-University Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947787
- Sponsor's protocol ID
- BewegtVersorgt
- Acronym
- BewegtVersorgt
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38777585Weissenfels 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.
PubMed 35964042
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System
- ClinicalTrials.gov ID
- NCT04947787
- Acronym / sponsor ID
- BewegtVersorgt / BewegtVersorgt
- Conditions
- Non-Communicable Chronic Diseases
- Keywords
- physical activity promotion, physical activity referral scheme, physician-initiated, behaviour change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Physical activity referral scheme (PARS)Participants receive a physical activity referral scheme. |
| Control Group | Active comparator | Behavioral: Physical activity advice (PAA)Participants receive physical activity advice from general practitioners. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Group |
| 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. | Behavioural | Control Group |
Primary outcome
Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Changes in physical activity-related health competence: BGK Questionnaire
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
5 secondary outcomes
Changes in quality of life: EuroQol (EQ-5D-5L)
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in self-efficacy towards physical activity: Selbstwirksamkeit zur sportlichen Aktivität-Skala (SSA-Scale)
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in participants' perceived autonomy support: Health Care Climate Questionnaire-Deutschland (HCCQ-D)
Time frame: Baseline (T0), 24 weeks (T1; only intervention group)
Changes in stages of change: transtheoretical model (TTM)
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in sport- and movement-related self-concordance: Sport- und bewegungsbezogenen Selbstkonkordanz Skala (SSK-Scale)
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 38777585Klamroth 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.
- Derived from this study: PubMed 35964042Weissenfels 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.
- Individual participant dataSharing planned: Undecided
Related trials for Non-Communicable Chronic Diseases
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingObservational study
Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data
Non-communicable Diseases (NCD), Neoplams
RecruitingObservational study
Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease
Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease
Not yet recruitingObservational study
Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness
Liver Fibrosis, Liver Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Pfeifer, Prof. Dr. principal investigator
Friedrich-Alexander-University Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity referral scheme (PARS) and Physical activity advice (PAA) in people with Non-Communicable Chronic Diseases, run by University of Erlangen-Nürnberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire (time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04947787, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.