Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation; Feasibility Studies; Organization and Administration; Rehabilitation Exercise
• Intervention / Treatment: Procedure: Version 1: Paramedic; Procedure: Version 2: Physician-on-call; Procedure: Version 3: Trained instructor

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 Type: Interventional
• Enrollment (Actual): 446
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30169
      • Behinderten-Sportverband Niedersachsen e.V.
  • North-Rhine Westfalia
    • Frechen, North-Rhine Westfalia, Germany, 50226
      • National Paralympic Committee Germany (NPCG)
    • Münster, North-Rhine Westfalia, Germany, 48149
      • Instiute of Sport and Exercise Sciences
  • Saxony
    • Leipzig, Saxony, Germany, 04105
      • Sächsischer Behinderten- und Rehabilitationssportverband e. V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• For participants: Participation in the heart sports group with the consent of the prescribing physician

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Version 1: Paramedic; Physician is replaced by a paramedic, but the physician still acts as a supervisor.	Procedure: Version 1: Paramedic; 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.
EXPERIMENTAL: Version 2: Physician-on-call; Physician is not present, but is on call.	Procedure: Version 2: Physician-on-call; 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.
EXPERIMENTAL: Version 3: Trained instructor; Physician acts as a supervisor, but is not constantly present. The instructor received a special training preparing for emergency cases.	Procedure: Version 3: Trained instructor; 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.
NO_INTERVENTION: Control group; The sessions take place in the usual way, meaning that a physician is present in every session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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".	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".	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).	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).	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).	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).	Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other questions on the implementation of the concept (M3)	The questionnaire containing the 4 primary outcome questions includes also other questions on the implementation of the concept, e.g. the supervision, the communication between actors and the activity of the exercise instructor. No score is calculated.	Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Other questions on the implementation of the concept (M10)	The questionnaire containing the 4 primary outcome questions includes also other questions on the implementation of the concept, e.g. the supervision, the communication between actors and the activity of the exercise instructor. No score is calculated.	Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.

Collaborators and Investigators

• Sponsor: Westfälische Wilhelms-Universität Münster
• Collaborators: National Paralympic Committee Germany (NPCG)
• Investigators: Study Director: Benedikt Ewald, National Paralympic Committee Germany (NPCG); Principal Investigator: Michael Brach, Prof. Dr., University of Münster

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2018
• Primary Completion (ACTUAL): December 8, 2019
• Study Completion (ACTUAL): May 21, 2020

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (ACTUAL): February 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: exercise; cardiac rehabilitation; perceived safety; medical supervision
• Other Study ID Numbers: 2019-28-MB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No