CClinicalTrials.gg
CompletedNCT04501432CODISUpdated Jan 6, 2022

Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19

An observational study in Cardiac Rehabilitation, sponsored by Ludwig Boltzmann Institute for Digital Health and Prevention. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-06.

Sponsored by Ludwig Boltzmann Institute for Digital Health and Prevention · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
27
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Rehabilitation

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Keywords

  • COVID-19
  • Exercise Tolerance
  • Physical Activity
  • Qualitative Interview
  • Secondary Prevention
  • Social Distancing
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 27 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Ludwig Boltzmann Institute for Digital Health and Prevention is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Contraindications for cardiopulmonary exercise testing
  • Pathologies limiting exercise performance
  • Pregnancy or breastfeeding
  • Limited German language
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
27 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherNo intervention

    This study does not include an intervention

06

What researchers measure

Primary outcomes

  1. Work load (W)

    Maximal work load (W) achieved in cycle ergometry test

    Time frame: up to 12 months

  2. Work load % of predicted value

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

    Time frame: up to 12 months

  3. Heart rate (bpm)

    Maximal heart rate (bpm) during cycle ergometry test

    Time frame: up to 12 months

  4. Framingham Recurrent Coronary Heart Disease risk score

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

    Time frame: up to 12 months

Secondary outcomes

  1. Metabolic Equivalent (MET) minutes / week

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

    Time frame: up to 12 months

  2. Patient Experience

    Semi-structured qualitative interview

    Time frame: 5 months

07

Study locations

1 site
  • Institute of Sports Medicine, Prevention and Rehabilitation
    Salzburg, 5020, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04501432
Lead sponsor
Ludwig Boltzmann Institute for Digital Health and Prevention
Collaborators
Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria
Responsible party
Sponsor
First posted
Aug 6, 2020
Start date
Jul 14, 2020
Primary completion
Oct 24, 2020
Completion
Oct 24, 2020
Last update
Jan 6, 2022

Study contacts

Stefan T Kulnik, PhD MRes
principal investigator · Ludwig Boltzmann Institute for Digital Health and Prevention

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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