Cardiac RehabilitationNCT04738383
Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation
A study testing Version 1: Paramedic, Version 2: Physician-on-call and Version 3: Trained instructor in people with Cardiac Rehabilitation and Rehabilitation Exercise, run by Universität Münster at 4 sites in Germany.
Trial summary
Exercise groups are a form of rehabilitation sport that is offered to cardiac patients (e.g. after a heart attack) in long-term rehabilitation. In Germany, the constant presence of a physician is mandatory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Rehabilitation Exercise, Organization and Administration
- What is being tested?
- Version 1: Paramedic, Version 2: Physician-on-call and Version 3: Trained instructor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 4 sitesGermany
- Study dates
- 5 Nov 2018to 21 May 2020
- 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
- For participants: Participation in the heart sports group with the consent of the prescribing physician
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
National Paralympic Committee Germany (NPCG)
Frechen, North-Rhine Westfalia, 50226
Behinderten-Sportverband Niedersachsen e.V.
Hanover, Lower Saxony, 30169
Sächsischer Behinderten- und Rehabilitationssportverband e. V.
Leipzig, Saxony, 04105
Instiute of Sport and Exercise Sciences
Münster, North-Rhine Westfalia, 48149
About this study
Exercise groups are a form of rehabilitation sport that is offered to cardiac patients (e.g. after a heart attack) in long-term rehabilitation. In Germany, the constant presence of a physician is mandatory. In order to meet the increasing demand for heart groups, the present study implements emergency care during the heart group sessions with three alternatives: paramedics, physician-on-call or specially trained instructors.
In the present study the investigators compare these alternatives (three experimental conditions) with the conventional way (control condition). Perceived safety, trust, acceptance and organisational feasibility are the main outcomes of the study. The methods used are questionnaires to the participants, instructors, organizers and, if applicable, paramedics. Additionally, partially structured interviews with attending physicians are conducted according to an interview guide.
Read the detailed description
Exercise groups are a form of rehabilitation sport that is offered to cardiac patients (e.g. after a heart attack) in long-term rehabilitation. In Germany it is paid for by the health insurance, when certain quality criteria are fulfilled. Among others, the constant presence of a physician is mandatory. In order to meet the increasing demand for heart groups, the National Paralympic Committee Germany (NPCG) received a special permit to try other forms of medical care during a pilot project. In this so-called "supervisor conception" the physician focuses on higher-level supervision for several exercise groups. Emergency care during the heart group sessions is ensured with three alternatives: by paramedics, by a physician-on-call or by specially trained instructors.
In the present study the investigators compare these alternatives (three experimental conditions) with the conventional way (control condition). Before the start of the research project, the different versions were defined and approved by the NPCG and other responsible actors in German rehabilitation sport. The project is implemented for 12 months.
The objectives of the evaluation are:
- Safety and acceptance of the participants, instructors and supervisors with regard to medical care, consultation and cooperation, feasibility and communication between the interfaces.
- Learning effects and implementation of the training measures for emergency management and health education measures
- Implementability of the supervisor conception in the clubs and regional associations of the three model regions and transferability on the clubs and state associations of the NPCG.
The methods used are questionnaires to the participants, instructors, organizers and, if applicable, paramedics, in which the assessment of the respondents is measured for perceived safety, acceptance and feasibility. The questionnaires to the participants and instructors are carried out during a session by employees of the participating sports clubs. The organizers fill out their questionnaires at a self-chosen time point. The questionnaires were developed by the university and were sent out after the client has given his/her informed consent.
Additionally, partially structured interviews with attending physicians are conducted according to an interview guide. The questions address the physicians' assessment of safety, acceptance and feasibility of the supervisor conception.The guidelines are developed by us and are used by us after approval by the client. We conduct the interviews ourselves by telephone and evaluate them.
- Conditions
- Cardiac Rehabilitation, Rehabilitation Exercise, Organization and Administration, Feasibility Studies
- Being tested
- Version 1: Paramedic, Version 2: Physician-on-call, Version 3: Trained instructor
- Keywords
- perceived safety, cardiac rehabilitation, exercise, medical supervision
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Version 1: ParamedicProcedure or surgery
Instead of a physician, who is constantly present, a paramedic is present next to the instructor during the sessions, who can give first aid in case of an emergency and bridge the time until the ambulance arrives on site. The physician still acts as a supervisor visiting the group roughly every six weeks.
Version 2: Physician-on-callProcedure or surgery
This version implicates that a physician is not physically present but is on call during the sessions and must be constantly accessible by phone and able to arrive within three minutes in case of an emergency. To ensure this, version two should be implemented in facilities, which are linked to cardiac or rehabilitation center.
Version 3: Trained instructorProcedure or surgery
The sessions take place with the instructor only, who receives a comprehensive emergency training before and during the model phase and replaces the constantly present physician. Just like in the previous versions the physician still acts as a supervisor visiting the group roughly every six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Version 1: Paramedic | Experimental | Physician is replaced by a paramedic, but the physician still acts as a supervisor. Receives: Procedure: Version 1: Paramedic |
| Version 2: Physician-on-call | Experimental | Physician is not present, but is on call. Receives: Procedure: Version 2: Physician-on-call |
| Version 3: Trained instructor | Experimental | Physician acts as a supervisor, but is not constantly present. The instructor received a special training preparing for emergency cases. Receives: Procedure: Version 3: Trained instructor |
| Control group | No intervention | The sessions take place in the usual way, meaning that a physician is present in every session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trust at M3
Trust of the participants, instructors, organizers and paramedics towards the three alternative versions in cardiac rehabilitation. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no trust).
Measured: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Trust at M10
Trust of the participants, instructors, organizers and paramedics towards the three alternative versions in cardiac rehabilitation. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no trust).
Measured: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Willingness at M3
Willingness of the participants, instructors and organizers to implement the versions of the supervisor conception. It is assessed with a "yes-no-question" in the questionnaire. The feasibility criterion is met, if 50% or less of the respondents answer "no".
Measured: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Willingness at M10
Willingness of the participants, instructors and organizers to implement the versions of the supervisor conception. It is assessed with a "yes-no-question" in the questionnaire. The feasibility criterion is met, if 50% or less of the respondents answer "no".
Measured: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Potential at M3
Assessment of the organizers, instructors and paramedics if the supervisor conception has the potential to be able to offer more cardiac rehabilitation groups. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no potential).
Measured: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Potential at M10
Assessment of the organizers, instructors and paramedics if the supervisor conception has the potential to be able to offer more cardiac rehabilitation groups. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no potential).
Measured: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Costs at M3
Organizers are asked if the supervisor conception causes more, less or the same amount of costs compared to the conventional cardiac rehabilitation group. It is measured with one question offering a seven-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 6 or 7 (more or much more costs).
Measured: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Costs at M10
Organizers are asked if the supervisor conception causes more, less or the same amount of costs compared to the conventional cardiac rehabilitation group. It is measured with one question offering a seven-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 6 or 7 (more or much more costs).
Measured: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start5 Nov 2018
- Primary completion8 Dec 2019
- Study completion21 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- control group and 3 different forms of medical supervision
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Collaborators
- National Paralympic Committee Germany (NPCG)
- Responsible party
- Sponsor
- Investigators
- Benedikt Ewald, Study director, National Paralympic Committee Germany (NPCG)Michael Brach, Prof. Dr., Principal investigator, Universität Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738383
- Sponsor's protocol ID
- 2019-28-MB
- Status last verified
- Oct 2020
- First submitted
- 25 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT04738383
- Acronym / sponsor ID
- 2019-28-MB
- Conditions
- Cardiac Rehabilitation, Rehabilitation Exercise, Organization and Administration, Feasibility Studies
- Keywords
- perceived safety, cardiac rehabilitation, exercise, medical supervision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Collaborators
- National Paralympic Committee Germany (NPCG)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 8 Dec 2019 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 4 Feb 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.
Exercise groups are a form of rehabilitation sport that is offered to cardiac patients (e.g. after a heart attack) in long-term rehabilitation. In Germany, the constant presence of a physician is mandatory. In order to meet the increasing demand for heart groups, the present study implements emergency care during the heart group sessions with three alternatives: paramedics, physician-on-call or specially trained instructors.
In the present study the investigators compare these alternatives (three experimental conditions) with the conventional way (control condition). Perceived safety, trust, acceptance and organisational feasibility are the main outcomes of the study. The methods used are questionnaires to the participants, instructors, organizers and, if applicable, paramedics. Additionally, partially structured interviews with attending physicians are conducted according to an interview guide.
Detailed description
Exercise groups are a form of rehabilitation sport that is offered to cardiac patients (e.g. after a heart attack) in long-term rehabilitation. In Germany it is paid for by the health insurance, when certain quality criteria are fulfilled. Among others, the constant presence of a physician is mandatory. In order to meet the increasing demand for heart groups, the National Paralympic Committee Germany (NPCG) received a special permit to try other forms of medical care during a pilot project. In this so-called "supervisor conception" the physician focuses on higher-level supervision for several exercise groups. Emergency care during the heart group sessions is ensured with three alternatives: by paramedics, by a physician-on-call or by specially trained instructors.
In the present study the investigators compare these alternatives (three experimental conditions) with the conventional way (control condition). Before the start of the research project, the different versions were defined and approved by the NPCG and other responsible actors in German rehabilitation sport. The project is implemented for 12 months.
The objectives of the evaluation are:
- Safety and acceptance of the participants, instructors and supervisors with regard to medical care, consultation and cooperation, feasibility and communication between the interfaces.
- Learning effects and implementation of the training measures for emergency management and health education measures
- Implementability of the supervisor conception in the clubs and regional associations of the three model regions and transferability on the clubs and state associations of the NPCG.
The methods used are questionnaires to the participants, instructors, organizers and, if applicable, paramedics, in which the assessment of the respondents is measured for perceived safety, acceptance and feasibility. The questionnaires to the participants and instructors are carried out during a session by employees of the participating sports clubs. The organizers fill out their questionnaires at a self-chosen time point. The questionnaires were developed by the university and were sent out after the client has given his/her informed consent.
Additionally, partially structured interviews with attending physicians are conducted according to an interview guide. The questions address the physicians' assessment of safety, acceptance and feasibility of the supervisor conception.The guidelines are developed by us and are used by us after approval by the client. We conduct the interviews ourselves by telephone and evaluate them.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- control group and 3 different forms of medical supervision
| Arm | Type | Receives |
|---|---|---|
| Version 1: Paramedic | Experimental | Procedure: Version 1: ParamedicPhysician is replaced by a paramedic, but the physician still acts as a supervisor. |
| Version 2: Physician-on-call | Experimental | Procedure: Version 2: Physician-on-callPhysician is not present, but is on call. |
| Version 3: Trained instructor | Experimental | Procedure: Version 3: Trained instructorPhysician acts as a supervisor, but is not constantly present. The instructor received a special training preparing for emergency cases. |
| Control group | No intervention | –The sessions take place in the usual way, meaning that a physician is present in every session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- For participants: Participation in the heart sports group with the consent of the prescribing physician
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Version 1: ParamedicInstead of a physician, who is constantly present, a paramedic is present next to the instructor during the sessions, who can give first aid in case of an emergency and bridge the time until the ambulance arrives on site. The physician still acts as a supervisor visiting the group roughly every six weeks. | Procedure or surgery | Version 1: Paramedic |
| Version 2: Physician-on-callThis version implicates that a physician is not physically present but is on call during the sessions and must be constantly accessible by phone and able to arrive within three minutes in case of an emergency. To ensure this, version two should be implemented in facilities, which are linked to cardiac or rehabilitation center. | Procedure or surgery | Version 2: Physician-on-call |
| Version 3: Trained instructorThe sessions take place with the instructor only, who receives a comprehensive emergency training before and during the model phase and replaces the constantly present physician. Just like in the previous versions the physician still acts as a supervisor visiting the group roughly every six weeks. | Procedure or surgery | Version 3: Trained instructor |
Primary outcome
Trust at M3
Time frame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Trust of the participants, instructors, organizers and paramedics towards the three alternative versions in cardiac rehabilitation. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no trust).
Trust at M10
Time frame: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Trust of the participants, instructors, organizers and paramedics towards the three alternative versions in cardiac rehabilitation. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no trust).
Willingness at M3
Time frame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Willingness of the participants, instructors and organizers to implement the versions of the supervisor conception. It is assessed with a "yes-no-question" in the questionnaire. The feasibility criterion is met, if 50% or less of the respondents answer "no".
Willingness at M10
Time frame: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Willingness of the participants, instructors and organizers to implement the versions of the supervisor conception. It is assessed with a "yes-no-question" in the questionnaire. The feasibility criterion is met, if 50% or less of the respondents answer "no".
Potential at M3
Time frame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Assessment of the organizers, instructors and paramedics if the supervisor conception has the potential to be able to offer more cardiac rehabilitation groups. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no potential).
Potential at M10
Time frame: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Assessment of the organizers, instructors and paramedics if the supervisor conception has the potential to be able to offer more cardiac rehabilitation groups. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no potential).
Costs at M3
Time frame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Organizers are asked if the supervisor conception causes more, less or the same amount of costs compared to the conventional cardiac rehabilitation group. It is measured with one question offering a seven-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 6 or 7 (more or much more costs).
Costs at M10
Time frame: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Organizers are asked if the supervisor conception causes more, less or the same amount of costs compared to the conventional cardiac rehabilitation group. It is measured with one question offering a seven-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 6 or 7 (more or much more costs).
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 4 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Benedikt Ewald study director
National Paralympic Committee Germany (NPCG)
Michael Brach, Prof. Dr. principal investigator
Universität Münster
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Version 1: Paramedic, Version 2: Physician-on-call and Version 3: Trained instructor in people with Cardiac Rehabilitation and Rehabilitation Exercise, run by Universität Münster at 4 sites 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 1 inclusion and 1 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Trust at M3 (time frame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021.