Cardiovascular DiseasesNCT05449652
Exercise Prescriptions for Patients With Cardiovascular Disease
An observational study of Cardiovascular Diseases, run by Hasselt University at 1 site in Belgium.
Trial summary
Physiotherapists are often confronted with patients with (elevated risk for) cardiovascular disease (CVD), even when this is not the primary indication for physiotherapy. Hence, physiotherapists should be able to provide evidence-based exercise advice to these patients, but this has not been assessed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- To prescribe exercise prescription for CVD patients
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Feb 2022to 30 Apr 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Professionaly active Flemish physiotherapists.
Inclusion Criteria: Currently professionally active Flemish physiotherapists
Exclusion Criteria: Not having access to a device that allows the use of the EXercise Prescription in Everyday practice \& Rehabilitative Training (EXPERT) tool.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Exercise Prescriptions for Patients With Cardiovascular Disease, Made by Physiotherapists, in Agreement With International Guidelines?
Physiotherapists are often confronted with patients with (elevated risk for) cardiovascular disease (CVD), even when this is not the primary indication for physiotherapy. Hence, physiotherapists should be able to provide evidence-based exercise advice to these patients, but this has not been assessed. The aim of this study was therefore to assess whether exercise prescriptions by physiotherapists to patients with CVD are in accordance with international recommendations.
Read the detailed description
In this prospective observational survey, forty-seven Belgian physiotherapists agreed to prescribe exercise intensity, frequency, session duration, program duration, and exercise type (endurance or strength training) for the same three patient cases. Exercise prescriptions were compared between clinicians and relations with clinician characteristics were studied. In addition, the agreement between physiotherapists' exercise prescriptions and those from international recommendations (based on a maximal score of 60/per case) was assessed.
- Conditions
- Cardiovascular Diseases
- Being tested
- To prescribe exercise prescription for CVD patients
- Keywords
- physiotherapy, exercise prescription, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To prescribe exercise prescription for CVD patientsOther
To prescribe exercise intensity, frequency, session duration, program duration, and exercise type (endurance or strength training) for the same three patient cases
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise intensity
Assessment of the prescription of exercise intensity (expressed in heart rate in beats per minute)
Measured: February - April 2022
Exercise frequency
Assessment of exercise frequency (expressed in number of exercise sessions per week)
Measured: February - April 2022
Session duration
Assessment of session duration (expressed in number of minutes)
Measured: February - April 2022
Program duration
Assessment of program duration (expressed in number of weeks)
Measured: February - April 2022
Exercise type
Aerobic exercise or strength exercise
Measured: February - April 2022
Total exercise volume
Multiplication of number of prescribed weeks, number of prescribed sessions/week, prescribed individual session duration and prescribed exercise intensity
Measured: February - April 2022
Secondary outcomes (1)
Association between exercise prescriptions and clinician characteristics'
Relations between exercise prescriptions (intensity, frequency, session/program duration, exercise type) and clinician characteristics (age, gender, education, experience,...) were studied.
Measured: February - April 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start16 Feb 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique Hansen, Prof, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449652
- Sponsor's protocol ID
- AXXON
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marinus N, Cornelissen V, Meesen R, Coninx K, Hansen D. Are exercise prescriptions for patients with cardiovascular disease, made by physiotherapists, in agreement with European recommendations? Eur J Cardiovasc Nurs. 2024 Apr 12;23(3):230-240. doi: 10.1093/eurjcn/zvad065.
PubMed 37439451
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Exercise Prescriptions for Patients With Cardiovascular Disease, Made by Physiotherapists, in Agreement With International Guidelines?
- ClinicalTrials.gov ID
- NCT05449652
- Acronym / sponsor ID
- AXXON
- Conditions
- Cardiovascular Diseases
- Keywords
- physiotherapy, exercise prescription, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 8 Jul 2022 (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.
Physiotherapists are often confronted with patients with (elevated risk for) cardiovascular disease (CVD), even when this is not the primary indication for physiotherapy. Hence, physiotherapists should be able to provide evidence-based exercise advice to these patients, but this has not been assessed. The aim of this study was therefore to assess whether exercise prescriptions by physiotherapists to patients with CVD are in accordance with international recommendations.
Detailed description
In this prospective observational survey, forty-seven Belgian physiotherapists agreed to prescribe exercise intensity, frequency, session duration, program duration, and exercise type (endurance or strength training) for the same three patient cases. Exercise prescriptions were compared between clinicians and relations with clinician characteristics were studied. In addition, the agreement between physiotherapists' exercise prescriptions and those from international recommendations (based on a maximal score of 60/per case) was assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Professionaly active Flemish physiotherapists.
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 |
|---|---|---|
| To prescribe exercise prescription for CVD patientsTo prescribe exercise intensity, frequency, session duration, program duration, and exercise type (endurance or strength training) for the same three patient cases | Other | – |
Primary outcome
Exercise intensity
Time frame: February - April 2022
Assessment of the prescription of exercise intensity (expressed in heart rate in beats per minute)
Exercise frequency
Time frame: February - April 2022
Assessment of exercise frequency (expressed in number of exercise sessions per week)
Session duration
Time frame: February - April 2022
Assessment of session duration (expressed in number of minutes)
Program duration
Time frame: February - April 2022
Assessment of program duration (expressed in number of weeks)
Exercise type
Time frame: February - April 2022
Aerobic exercise or strength exercise
Total exercise volume
Time frame: February - April 2022
Multiplication of number of prescribed weeks, number of prescribed sessions/week, prescribed individual session duration and prescribed exercise intensity
1 secondary outcome
Association between exercise prescriptions and clinician characteristics'
Time frame: February - April 2022
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 8 Jul 2022.
- Derived from this study: PubMed 37439451Marinus N, Cornelissen V, Meesen R, Coninx K, Hansen D. Are exercise prescriptions for patients with cardiovascular disease, made by physiotherapists, in agreement with European recommendations? Eur J Cardiovasc Nurs. 2024 Apr 12;23(3):230-240. doi: 10.1093/eurjcn/zvad065.
- 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.
Dominique Hansen, Prof principal investigator
Hasselt University
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 Cardiovascular Diseases, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 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 Belgium. 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?
Exercise intensity (time frame: February - April 2022). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05449652, which also lists 1 linked publication.
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 8 Jul 2022.