Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19 (CODIS)

Cardiac Rehabilitation and Ongoing Physical Activity During the Coronavirus Disease (COVID-19) Pandemic: An Exploratory Mixed-Methods Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Institute of Sports Medicine, Prevention and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention; This study does not include an intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work load (W)	Maximal work load (W) achieved in cycle ergometry test	up to 12 months
Work load % of predicted value	Maximal work load (W) achieved in cycle ergometry test expressed as percentage of predicted value	up to 12 months
Heart rate (bpm)	Maximal heart rate (bpm) during cycle ergometry test	up to 12 months
Framingham Recurrent Coronary Heart Disease risk score	Range 1% to 29%, higher percentage indicating worse risk estimate	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic Equivalent (MET) minutes / week	MET-minutes/week calculated from patient self-report of physical activity (International Physical Activity Questionnaire, IPAQ, 7 day version)	up to 12 months
Patient Experience	Semi-structured qualitative interview	5 months

Collaborators and Investigators

• Sponsor: Ludwig Boltzmann Institute for Digital Health and Prevention
• Collaborators: Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria
• Investigators: Principal Investigator: Stefan T Kulnik, PhD MRes, Ludwig Boltzmann Institute for Digital Health and Prevention

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 14, 2020
• Primary Completion (ACTUAL): October 24, 2020
• Study Completion (ACTUAL): October 24, 2020

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (ACTUAL): August 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Physical Activity; COVID-19; Exercise Tolerance; Secondary Prevention; Social Distancing; Qualitative Interview
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 23_CODIS

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