Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19

NCT04501432 | Completed

• 1 other identifier: 23_CODIS
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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. 1.What was the impact of the COVID-19-related lockdown on patients' physical activity and physical fitness levels? (QUANT stage)
2. 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. 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)

Conditions

Cardiac Rehabilitation

Keywords

COVID-19; Exercise Tolerance; Physical Activity; Qualitative Interview; Secondary Prevention; Social Distancing

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Metabolic Equivalent (MET) minutes / week

  up to 12 months

• Patient Experience

  5 months

Study Arms (1)

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

Interventions

No intervention OTHER

This study does not include an intervention

Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Contraindications for cardiopulmonary exercise testing
• Pathologies limiting exercise performance
• Pregnancy or breastfeeding
• Limited German language

Sponsors & Collaborators

• Ludwig Boltzmann Institute for Digital Health and Prevention: lead
• Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria: collaborator

Study Sites (1)

Institute of Sports Medicine, Prevention and Rehabilitation

Salzburg, 5020, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

COVID-19; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Stefan T Kulnik, PhD MRes

  Ludwig Boltzmann Institute for Digital Health and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: July 14, 2020
• Primary Completion: October 24, 2020
• Study Completion: October 24, 2020
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)