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

NCT04738383 | Completed

• 1 other identifier: 2019-28-MB
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

perceived safety; cardiac rehabilitation; exercise; medical supervision

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Other questions on the implementation of the concept (M3)

  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)

  Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.

Study Arms (4)

Version 1: Paramedic

EXPERIMENTAL

Physician is replaced by a paramedic, but the physician still acts as a supervisor.

Procedure: Version 1: Paramedic

Version 2: Physician-on-call

EXPERIMENTAL

Physician is not present, but is on call.

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.

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.

Interventions

Version 1: Paramedic PROCEDURE

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 1: Paramedic

Version 2: Physician-on-call PROCEDURE

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 2: Physician-on-call

Version 3: Trained instructor PROCEDURE

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.

Version 3: Trained instructor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Universität Münster: lead
• National Paralympic Committee Germany (NPCG): collaborator

Study Sites (4)

Behinderten-Sportverband Niedersachsen e.V.

Hanover, Lower Saxony, 30169, Germany

Location

National Paralympic Committee Germany (NPCG)

Frechen, North-Rhine Westfalia, 50226, Germany

Location

Instiute of Sport and Exercise Sciences

Münster, North-Rhine Westfalia, 48149, Germany

Location

Sächsischer Behinderten- und Rehabilitationssportverband e. V.

Leipzig, Saxony, 04105, Germany

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Benedikt Ewald

  National Paralympic Committee Germany (NPCG)

  STUDY DIRECTOR

• Michael Brach, Prof. Dr.

  Universität Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: control group and 3 different forms of medical supervision

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 4, 2021
• Study Start: November 5, 2018
• Primary Completion: December 8, 2019
• Study Completion: May 21, 2020
• Last Updated: February 4, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)