Clinical trial NCT04501432: Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19
Official title: Cardiac Rehabilitation and Ongoing Physical Activity During the Coronavirus Disease (COVID-19) Pandemic: An Exploratory Mixed-Methods Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Rehabilitation
Keywords: COVID-19
Exercise Tolerance
Physical Activity
Qualitative Interview
Secondary Prevention
Social Distancing
Lead sponsor: Ludwig Boltzmann Institute for Digital Health and Prevention
Sponsor class: OTHER
Collaborators: name: Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria
First posted: 2020-08-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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.

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:

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.


Eligibility criteria: 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

Primary outcomes:
measure: Work load (W)
timeFrame: up to 12 months
measure: Work load % of predicted value
timeFrame: up to 12 months
measure: Heart rate (bpm)
timeFrame: up to 12 months
measure: Framingham Recurrent Coronary Heart Disease risk score
timeFrame: up to 12 months
Secondary outcomes:
measure: Metabolic Equivalent (MET) minutes / week
timeFrame: up to 12 months
measure: Patient Experience
timeFrame: 5 months
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Institute of Sports Medicine, Prevention and Rehabilitation
Study officials:
affiliation: Ludwig Boltzmann Institute for Digital Health and Prevention
name: Stefan T Kulnik, PhD MRes
role: PRINCIPAL_INVESTIGATOR
References: