Disease, ChronicNCT05282342
Heart Transplant Patients, Health Status and Physical Activity
An observational study of Disease, Chronic, run by Luis Santos at 1 site in Spain.
Trial summary
The aim of this cross-sectional observational study is (1) to assess the health status of a group of heart transplant patients and their level of physical activity, (2) and to compare the health status of a group of heart transplant patients with different levels of physical activity, with a group of healthy people… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Disease, Chronic
- What is being tested?
- Diagnostic tests
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 30 Jun 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Active and sedentary heart transplant patients and sedentary healthy people.
Who may be able to join
- Heart transplant adults (18 years old) whose transplant had taken place at least twelve months before the study data was taken.
- Heart transplant patients with low, moderate and high levels of physical activity, according to the results of the International Physical Activity Questionnaire - Long Form (IPAQ-L).
- Healthy people with low levels of physical activity, according to the results of the International Physical Activity Questionnaire - Long Form (IPAQ-L).
Who cannot join
- Do not meet the eligibility criteria.
- Have physical disabilities and/or other limiting pathologies that would condition their level of physical activity.
- Have participated in cardiac rehabilitation programs during the twelve months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of the Health Status of Heart Transplant Patients With Different Levels of Physical Activity
The aim of this cross-sectional observational study is (1) to assess the health status of a group of heart transplant patients and their level of physical activity, (2) and to compare the health status of a group of heart transplant patients with different levels of physical activity, with a group of healthy people classified as sedentary (due to their level of physical activity).
- Conditions
- Disease, Chronic
- Being tested
- Diagnostic tests
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testsDiagnostic test
No intervention will be carried out. Participants of the whole groups will be underwent the same tests.
| Study group | Role | What they receive |
|---|---|---|
| Transplanted with low levels of physical activity (TPL) | Not described Receives: Diagnostic Test: Diagnostic tests | |
| Transplanted with moderate levels of physical activity (TPM) | Not described Receives: Diagnostic Test: Diagnostic tests | |
| Transplanted with high levels of physical activity (TPH) | Not described Receives: Diagnostic Test: Diagnostic tests | |
| Healthy sedentary individuals (S) | Not described Receives: Diagnostic Test: Diagnostic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular function assessment.
Analysis of several cardiovascular variables.
Measured: Through study completion, an average of 1 year.
Neuromuscular function assessment.
Analysis of several neuromuscular variables.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Basic blood analysis
Analysis of several blood parameters
Measured: Through study completion, an average of 1 year.
Flexibility
Analysis of several flexibility variables.
Measured: Through study completion, an average of 1 year.
Balance
Analysis of several balance variables.
Measured: Through study completion, an average of 1 year.
Functional Capacity
Analysis of several functional mobility variables.
Measured: Through study completion, an average of 1 year.
Quality of Life Status
Analysis of several quality of life variables.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start10 Jan 2022
- Primary completion10 Jan 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease, ChronicStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luis Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luis Santos, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282342
- Sponsor's protocol ID
- ETICA-ULE-038-2021
- Status last verified
- Apr 2024
- First submitted
- 29 Dec 2021
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Health Status of Heart Transplant Patients With Different Levels of Physical Activity
- ClinicalTrials.gov ID
- NCT05282342
- Acronym / sponsor ID
- ETICA-ULE-038-2021
- Conditions
- Disease, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Luis SantosUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Mar 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.
The aim of this cross-sectional observational study is (1) to assess the health status of a group of heart transplant patients and their level of physical activity, (2) and to compare the health status of a group of heart transplant patients with different levels of physical activity, with a group of healthy people classified as sedentary (due to their level of physical activity).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transplanted with low levels of physical activity (TPL) | – | Diagnostic Test: Diagnostic tests |
| Transplanted with moderate levels of physical activity (TPM) | – | Diagnostic Test: Diagnostic tests |
| Transplanted with high levels of physical activity (TPH) | – | Diagnostic Test: Diagnostic tests |
| Healthy sedentary individuals (S) | – | Diagnostic Test: Diagnostic tests |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Active and sedentary heart transplant patients and sedentary healthy people.
Key inclusion criteria (3 listed)
- Heart transplant adults (18 years old) whose transplant had taken place at least twelve months before the study data was taken.
- Heart transplant patients with low, moderate and high levels of physical activity, according to the results of the International Physical Activity Questionnaire - Long Form (IPAQ-L).
- Healthy people with low levels of physical activity, according to the results of the International Physical Activity Questionnaire - Long Form (IPAQ-L).
Key exclusion criteria (3 listed)
- Do not meet the eligibility criteria.
- Have physical disabilities and/or other limiting pathologies that would condition their level of physical activity.
- Have participated in cardiac rehabilitation programs during the twelve months prior to the study.
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 |
|---|---|---|
| Diagnostic testsNo intervention will be carried out. Participants of the whole groups will be underwent the same tests. | Diagnostic test | Healthy sedentary individuals (S), Transplanted with high levels of physical activity (TPH), Transplanted with low levels of physical activity (TPL), Transplanted with moderate levels of physical activity (TPM) |
Primary outcome
Cardiovascular function assessment.
Time frame: Through study completion, an average of 1 year.
Analysis of several cardiovascular variables.
Neuromuscular function assessment.
Time frame: through study completion, an average of 1 year
Analysis of several neuromuscular variables.
5 secondary outcomes
Basic blood analysis
Time frame: Through study completion, an average of 1 year.
Flexibility
Time frame: Through study completion, an average of 1 year.
Balance
Time frame: Through study completion, an average of 1 year.
Functional Capacity
Time frame: Through study completion, an average of 1 year.
Quality of Life Status
Time frame: Through study completion, an average of 1 year.
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 30 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disease, Chronic, run by Luis Santos at 1 site in Spain.
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 3 inclusion and 3 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 30 Apr 2024. 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 Spain. 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?
Cardiovascular function assessment. (time frame: Through study completion, an average of 1 year.). The study lists 2 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 30 Apr 2024.