Heart Transplant Patients, Health Status and Physical Activity

NCT05282342 | Completed

• 1 other identifier: ETICA-ULE-038-2021
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Disease, Chronic

Outcome Measures

Primary Outcomes (2)

• Cardiovascular function assessment.

  Analysis of several cardiovascular variables.

  Through study completion, an average of 1 year.

• Neuromuscular function assessment.

  Analysis of several neuromuscular variables.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Basic blood analysis

  Through study completion, an average of 1 year.

• Flexibility

  Through study completion, an average of 1 year.

• Balance

  Through study completion, an average of 1 year.

• Functional Capacity

  Through study completion, an average of 1 year.

• Quality of Life Status

  Through study completion, an average of 1 year.

Study Arms (4)

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

Interventions

Diagnostic tests DIAGNOSTIC_TEST

No intervention will be carried out. Participants of the whole groups will be underwent the same tests.

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)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active and sedentary heart transplant patients and sedentary healthy people.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luis Santos: lead

Study Sites (1)

Itziar Salas Reguera

León, León, Castilla Y León, 24007, Spain

Location

MeSH Terms

Conditions

Chronic Disease

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: March 16, 2022
• Study Start: January 10, 2022
• Primary Completion: January 10, 2022
• Study Completion: June 30, 2022
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

ES (1)