Heart Transplant Patients, Health Status and Physical Activity

Disease, Chronic Clinical Trial

Official title:

Comparative Analysis of the Health Status of Heart Transplant Patients With Different Levels of Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05282342
• Other study ID #: ETICA-ULE-038-2021
• Status: Completed
• Start date: January 10, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2024
• Source: University of Oviedo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 classified as sedentary (due to their level of physical activity).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 30, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Disease, Chronic

Intervention

Diagnostic Test:
• Diagnostic tests
No intervention will be carried out. Participants of the whole groups will be underwent the same tests.

Locations

Country	Name	City	State
Spain	Itziar Salas Reguera	León	León, Castilla Y León

Sponsors (1)

Lead Sponsor	Collaborator
Luis Santos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular function assessment.	Analysis of several cardiovascular variables.	Through study completion, an average of 1 year.
Primary	Neuromuscular function assessment.	Analysis of several neuromuscular variables.	through study completion, an average of 1 year
Secondary	Basic blood analysis	Analysis of several blood parameters	Through study completion, an average of 1 year.
Secondary	Flexibility	Analysis of several flexibility variables.	Through study completion, an average of 1 year.
Secondary	Balance	Analysis of several balance variables.	Through study completion, an average of 1 year.
Secondary	Functional Capacity	Analysis of several functional mobility variables.	Through study completion, an average of 1 year.
Secondary	Quality of Life Status	Analysis of several quality of life variables.	Through study completion, an average of 1 year.