Heart Transplant Patients, Health Status and Physical Activity

Completed

• Conditions: Disease, Chronic
• Interventions: Diagnostic Test: Diagnostic tests

• Registration Number: NCT05282342
• Lead Sponsor: Luis Santos

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Study Start: 2022-01-10
• Primary Completion: 2022-01-10
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Study Completion: 2022-06-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-28
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy sedentary individuals (S)	Diagnostic tests	-
Transplanted with low levels of physical activity (TPL)	Diagnostic tests	-
Transplanted with high levels of physical activity (TPH)	Diagnostic tests	-
Transplanted with moderate levels of physical activity (TPM)	Diagnostic tests	-

Primary Outcome Measures

Name	Time	Method
Cardiovascular function assessment.	Through study completion, an average of 1 year.	Analysis of several cardiovascular variables.
Neuromuscular function assessment.	through study completion, an average of 1 year	Analysis of several neuromuscular variables.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Itziar Salas Reguera; 🇪🇸 León, León, Castilla Y León, Spain