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Completed

NCT Number: NCT05282342

Heart Transplant Patients, Health Status and 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).

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Itziar Salas Reguera

León, León, Castilla Y León, 24007, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic tests

Diagnostic Test

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

Primary outcomes

  1. Cardiovascular function assessment.

    Time frame: Through study completion, an average of 1 year.

    Analysis of several cardiovascular variables.

  2. Neuromuscular function assessment.

    Time frame: through study completion, an average of 1 year

    Analysis of several neuromuscular variables.

Secondary outcomes

  1. Basic blood analysis

    Time frame: Through study completion, an average of 1 year.

    Analysis of several blood parameters

  2. Flexibility

    Time frame: Through study completion, an average of 1 year.

    Analysis of several flexibility variables.

  3. Balance

    Time frame: Through study completion, an average of 1 year.

    Analysis of several balance variables.

  4. Functional Capacity

    Time frame: Through study completion, an average of 1 year.

    Analysis of several functional mobility variables.

  5. Quality of Life Status

    Time frame: Through study completion, an average of 1 year.

    Analysis of several quality of life variables.

Sponsors and collaborators

Lead sponsor

Luis Santos

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2022
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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