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

NCT04738383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2021-02-04

No results posted yet for this study

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. 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.

Conditions

  • Cardiac Rehabilitation
  • Rehabilitation Exercise
  • Organization and Administration
  • Feasibility Studies

Interventions

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.

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.

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.

Sponsors & Collaborators

  • National Paralympic Committee Germany (NPCG)

    collaborator UNKNOWN
  • Universität Münster

    lead OTHER

Principal Investigators

  • Benedikt Ewald · National Paralympic Committee Germany (NPCG)

  • Michael Brach, Prof. Dr. · Universität Münster

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2019-12-08
Completion
2020-05-21

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738383 on ClinicalTrials.gov