CODIS: Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19

Sponsor

Ludwig Boltzmann Institute for Digital Health and Prevention (Other)

Overall Status

Completed

CT.gov ID

NCT04501432

Collaborator

Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria (Other)

Enrollment

Location

3.4

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

What was the impact of the COVID-19-related lockdown on patients' physical activity and physical fitness levels? (QUANT stage)
What was the patient experience of the closure of group-based cardiac rehabilitation training due to COVID-19 public health restrictions? (QUAL stage)
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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Rehabilitation	Other: No intervention

Study Design

Study Type:

Observational

Actual Enrollment :

27 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jul 14, 2020

Actual Primary Completion Date :

Oct 24, 2020

Actual Study Completion Date :

Oct 24, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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