Cardiac RehabilitationCODISNCT04501432
Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19
An observational study of Cardiac Rehabilitation, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- How many people
- 27 participants
- Where
- 1 siteAustria
- Study dates
- 14 Jul 2020to 24 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adults (18 years and over)
- Cardiovascular disease (CVD)
- Currently enrolled in outpatient cardiac rehabilitation training at the study site
- Informed consent
Who cannot join
- Contraindications for cardiopulmonary exercise testing
- Pathologies limiting exercise performance
- Pregnancy or breastfeeding
- Limited German language
Trial locations and contacts
1 site in 1 country.
Austria1 site
Institute of Sports Medicine, Prevention and Rehabilitation
Salzburg, 5020
About this study
Official title: Cardiac Rehabilitation and Ongoing Physical Activity During the Coronavirus Disease (COVID-19) Pandemic: An Exploratory Mixed-Methods Study
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.
Read more
The study poses three research questions, which will be addressed in a mixed-methods study with sequential quantitative-qualitative (QUANT-QUAL) design:
- What was the impact of the COVID-19-related lockdown on patients' physical activity and physical fitness levels? (QUANT stage)
- What was the patient experience of the closure of group-based cardiac rehabilitation training due to COVID-19 public health restrictions? (QUAL stage)
- 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.
- Conditions
- Cardiac Rehabilitation
- Being tested
- No intervention
- Keywords
- COVID-19, Exercise Tolerance, Physical Activity, Qualitative Interview, Secondary Prevention, Social Distancing
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This study does not include an intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work load (W)
Maximal work load (W) achieved in cycle ergometry test
Measured: up to 12 months
Work load % of predicted value
Maximal work load (W) achieved in cycle ergometry test expressed as percentage of predicted value
Measured: up to 12 months
Heart rate (bpm)
Maximal heart rate (bpm) during cycle ergometry test
Measured: up to 12 months
Framingham Recurrent Coronary Heart Disease risk score
Range 1% to 29%, higher percentage indicating worse risk estimate
Measured: up to 12 months
Secondary outcomes (2)
Metabolic Equivalent (MET) minutes / week
MET-minutes/week calculated from patient self-report of physical activity (International Physical Activity Questionnaire, IPAQ, 7 day version)
Measured: up to 12 months
Patient Experience
Semi-structured qualitative interview
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start14 Jul 2020
- Primary completion24 Oct 2020
- Study completion24 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria
- Responsible party
- Sponsor
- Investigators
- Stefan T Kulnik, PhD MRes, Principal investigator, Ludwig Boltzmann Institute for Digital Health and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501432
- Sponsor's protocol ID
- 23_CODIS
- Acronym
- CODIS
- Status last verified
- Dec 2021
- First submitted
- 29 Jul 2020
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation and Ongoing Physical Activity During the Coronavirus Disease (COVID-19) Pandemic: An Exploratory Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT04501432
- Acronym / sponsor ID
- CODIS / 23_CODIS
- Conditions
- Cardiac Rehabilitation
- Keywords
- COVID-19, Exercise Tolerance, Physical Activity, Qualitative Interview, Secondary Prevention, Social Distancing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and PreventionUniversity, hospital or other
- Collaborators
- Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- 24 Oct 2020 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What was the impact of the COVID-19-related lockdown on patients' physical activity and physical fitness levels? (QUANT stage)
- What was the patient experience of the closure of group-based cardiac rehabilitation training due to COVID-19 public health restrictions? (QUAL stage)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation | – | Other: No interventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults (18 years and over)
- Cardiovascular disease (CVD)
- Currently enrolled in outpatient cardiac rehabilitation training at the study site
- Informed consent
Key exclusion criteria (4 listed)
- Contraindications for cardiopulmonary exercise testing
- Pathologies limiting exercise performance
- Pregnancy or breastfeeding
- Limited German language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis study does not include an intervention | Other | Cardiac Rehabilitation |
Primary outcome
Work load (W)
Time frame: up to 12 months
Maximal work load (W) achieved in cycle ergometry test
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
Heart rate (bpm)
Time frame: up to 12 months
Maximal heart rate (bpm) during cycle ergometry test
Framingham Recurrent Coronary Heart Disease risk score
Time frame: up to 12 months
Range 1% to 29%, higher percentage indicating worse risk estimate
2 secondary outcomes
Metabolic Equivalent (MET) minutes / week
Time frame: up to 12 months
Patient Experience
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan T Kulnik, PhD MRes principal investigator
Ludwig Boltzmann Institute for Digital Health and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work load (W) (time frame: up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.