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Completed

NCT Number: NCT04501432

Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Sports Medicine, Prevention and Rehabilitation

Salzburg, 5020, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This study does not include an intervention

Primary outcomes

  1. Work load (W)

    Time frame: up to 12 months

    Maximal work load (W) achieved in cycle ergometry test

  2. Work load % of predicted value

    Time frame: up to 12 months

    Maximal work load (W) achieved in cycle ergometry test expressed as percentage of predicted value

  3. Heart rate (bpm)

    Time frame: up to 12 months

    Maximal heart rate (bpm) during cycle ergometry test

  4. Framingham Recurrent Coronary Heart Disease risk score

    Time frame: up to 12 months

    Range 1% to 29%, higher percentage indicating worse risk estimate

Secondary outcomes

  1. Metabolic Equivalent (MET) minutes / week

    Time frame: up to 12 months

    MET-minutes/week calculated from patient self-report of physical activity (International Physical Activity Questionnaire, IPAQ, 7 day version)

  2. Patient Experience

    Time frame: 5 months

    Semi-structured qualitative interview

Sponsors and collaborators

Lead sponsor

Ludwig Boltzmann Institute for Digital Health and Prevention

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CODIS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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