Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19

Cardiac Rehabilitation Clinical Trial

— CODIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501432
• Other study ID #: 23_CODIS
• Status: Completed
• Start date: July 14, 2020
• Est. completion date: October 24, 2020

Study information

• Verified date: December 2021
• Source: Ludwig Boltzmann Institute for Digital Health and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 24, 2020
• Est. primary completion date: October 24, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• COVID-19

Intervention

Other:
• No intervention
This study does not include an intervention

Locations

Country	Name	City	State
Austria	Institute of Sports Medicine, Prevention and Rehabilitation	Salzburg

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig Boltzmann Institute for Digital Health and Prevention	Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work load (W)	Maximal work load (W) achieved in cycle ergometry test	up to 12 months
Primary	Work load % of predicted value	Maximal work load (W) achieved in cycle ergometry test expressed as percentage of predicted value	up to 12 months
Primary	Heart rate (bpm)	Maximal heart rate (bpm) during cycle ergometry test	up to 12 months
Primary	Framingham Recurrent Coronary Heart Disease risk score	Range 1% to 29%, higher percentage indicating worse risk estimate	up to 12 months
Secondary	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
Secondary	Patient Experience	Semi-structured qualitative interview	5 months