Heart Transplant Patients, Health Status and Physical Activity

April 28, 2024 updated by: Luis Santos

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • León, Castilla Y León
      • León, León, Castilla Y León, Spain, 24007
        • Itziar Salas Reguera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Active and sedentary heart transplant patients and sedentary healthy people.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transplanted with low levels of physical activity (TPL)
Diagnostic test: Diagnostic tests
No intervention will be carried out. Participants of the whole groups will be underwent the same tests.
Transplanted with moderate levels of physical activity (TPM)
Diagnostic test: Diagnostic tests
No intervention will be carried out. Participants of the whole groups will be underwent the same tests.
Transplanted with high levels of physical activity (TPH)
Diagnostic test: Diagnostic tests
No intervention will be carried out. Participants of the whole groups will be underwent the same tests.
Healthy sedentary individuals (S)
Diagnostic test: Diagnostic tests
No intervention will be carried out. Participants of the whole groups will be underwent the same tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular function assessment.
Time Frame: Through study completion, an average of 1 year.
Analysis of several cardiovascular variables.
Through study completion, an average of 1 year.
Neuromuscular function assessment.
Time Frame: through study completion, an average of 1 year
Analysis of several neuromuscular variables.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: Through study completion, an average of 1 year.
Analysis of several balance variables.
Through study completion, an average of 1 year.
Flexibility
Time Frame: Through study completion, an average of 1 year.
Analysis of several flexibility variables.
Through study completion, an average of 1 year.
Functional Capacity
Time Frame: Through study completion, an average of 1 year.
Analysis of several functional mobility variables.
Through study completion, an average of 1 year.
Quality of Life Status
Time Frame: Through study completion, an average of 1 year.
Analysis of several quality of life variables.
Through study completion, an average of 1 year.
Basic blood analysis
Time Frame: Through study completion, an average of 1 year.
Analysis of several blood parameters
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luis Santos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

January 10, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETICA-ULE-038-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Disease, Chronic

Clinical Trials on Diagnostic tests

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe