Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19

NCT ID: NCT04501432

Last Updated: 2022-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-14

Study Completion Date

2020-10-24

Brief Summary

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The current Coronavirus Disease 2019 (COVID-19) pandemic has resulted in extraordinary public health orders of social distancing and self-isolation, leading to widespread disruption and discontinuation of cardiac rehabilitation programmes and other social opportunities for cardiovascular disease (CVD) patients to exercise. In Austria, the government initiated drastic public health measures (national lockdown) on March 16, 2020, leading to closure of all outpatient cardiac rehabilitation facilities and restriction of inpatient rehabilitation to patients with urgent medical indications only.

This study aims to explore the impact of COVID-19-related national lockdown and public health restrictions on cardiac rehabilitation patients, with respect to maintenance of physical activity for secondary CVD prevention.

The study poses three research questions, which will be addressed in a mixed-methods study with sequential quantitative-qualitative (QUANT-QUAL) design:

1. What was the impact of the COVID-19-related lockdown on patients' physical activity and physical fitness levels? (QUANT stage)
2. What was the patient experience of the closure of group-based cardiac rehabilitation training due to COVID-19 public health restrictions? (QUAL stage)
3. Which insights and learning points may be drawn from patients' experiences during COVID-19 public health restrictions with respect to the provision of home-based digital support for physical activity? (QUAL stage)

The study will recruit a cohort of up to 40 cardiac rehabilitation patients from one outpatient cardiac rehabilitation centre in Salzburg, Austria, whose rehabilitation programme was interrupted by COVID-19 public health orders, including "lockdown".

Patients will undergo re-assessment of physical fitness in cycle ergometry test and re-assessment of cardiovascular risk profile. This will be compared with patients' most recent available test results from before the COVID-19 lockdown (i.e. prior to mid-March 2020) from patient records. Additionally, patients will take part in a semi-structured qualitative interview in which they will be invited to reflect on their personal experiences during the COVID-19 lockdown and thereafter.

Detailed Description

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Conditions

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Cardiac Rehabilitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cardiac Rehabilitation

Participants will be recruited from a group of patients who regularly attended group-based cardiac rehabilitation exercise training at the study site until COVID-19 restrictions (national lockdown) came into force on 16th March 2020.

No intervention

Intervention Type OTHER

This study does not include an intervention

Interventions

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No intervention

This study does not include an intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults (18 years and over)
* Cardiovascular disease (CVD)
* Currently enrolled in outpatient cardiac rehabilitation training at the study site
* Informed consent

Exclusion Criteria

* Contraindications for cardiopulmonary exercise testing
* Pathologies limiting exercise performance
* Pregnancy or breastfeeding
* Limited German language
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria

UNKNOWN

Sponsor Role collaborator

Ludwig Boltzmann Institute for Digital Health and Prevention

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan T Kulnik, PhD MRes

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann Institute for Digital Health and Prevention

Locations

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Institute of Sports Medicine, Prevention and Rehabilitation

Salzburg, , Austria

Site Status

Countries

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Austria

Other Identifiers

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23_CODIS

Identifier Type: -

Identifier Source: org_study_id

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