Clinical trial NCT06206967: Promotion of Active Lifestyle in Thromboembolism Patients
Official title: Rehabilitation Program for Promotion Active Lifestyle After Suffering a Pulmonary Thromboembolism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Thromboembolism
Keywords: Pulmonary Thromboembolism
Rehabilitation
Activity Promotion
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who have suffered a pulmonary thromboembolism used to reduce their activity levels because of the symptoms and the fear to suffer other pulmonary thromboembolism. These patients often have sequelae after the hospitalization that previous studies have associated with a lack of physical activity.

The main objective of this research is to investigate the efficacy of a rehabilitation program for promotion higher activity levels in quality of life and self-perceived discapacity of thromboembolism patients.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes.
* Agreed to participate.
* Thromboembolism patients meeting the diagnosis criteria for this disease.

Exclusion Criteria:

* Neurological or orthopaedic pathologies that limited voluntary movement.
* Cognitive impairment that prevented them from understanding and answering the questionnaires.
* Patients suffering from a previous pulmonary thromboembolism.
* Patients who don´t understand Spanish language

Primary outcomes:
measure: Changes in discapacity
timeFrame: Baseline
measure: Changes in discapacity
timeFrame: Immediately after the hospital stay
measure: Changes in discapacity
timeFrame: At 12 weeks at the hospital discharge
measure: Quality of life measure with EuroQol-5D-5L
timeFrame: Baseline
measure: Quality of life measure with EuroQol-5D-5L
timeFrame: Immediately after the hospital stay
measure: Quality of life measure with EuroQol-5D-5L
timeFrame: At 12 weeks at the hospital discharge
measure: Physical Activity Levels measured wit IPAQ
timeFrame: Baseline
measure: Physical Activity Levels measured wit IPAQ
timeFrame: At 12 weeks at the hospital discharge
Secondary outcomes:
measure: Dyspnoea
timeFrame: Baseline
measure: Dyspnoea
timeFrame: Immediately after the hospital stay
measure: Dyspnoea
timeFrame: At 12 weeks at the hospital discharge
measure: Changes in Psycho-emotional status
timeFrame: Baseline
measure: Changes in Psycho-emotional status
timeFrame: Hospital Discharge
measure: Changes in Psycho-emotional status
timeFrame: At 12 weeks at the hospital discharge
measure: Changes in Performance status
timeFrame: Baseline
measure: Changes in Performance status
timeFrame: Immediately after the hospital stay
measure: Changes in Performance status
timeFrame: At 12 weeks at the hospital discharge
measure: Changes in Breathlessness Beliefs
timeFrame: Baseline
measure: Changes in Breathlessness Beliefs
timeFrame: Immediately after the hospital stay
measure: Changes in Breathlessness Beliefs
timeFrame: At 12 weeks at the hospital discharge
measure: Changes in managing the own healthcare
timeFrame: Immediately after the hospital stay
measure: Changes in managing the own healthcare
timeFrame: At 12 weeks at the hospital discharge
measure: Changes in physical functioning
timeFrame: Baseline
measure: Changes in physical functioning
timeFrame: Immediately after the hospital stay
measure: Changes in physical functioning
timeFrame: At 12 weeks at the hospital discharge
measure: Changes in Maximal Grip Strength
timeFrame: Baseline
measure: Changes in Maximal Grip Strength
timeFrame: Immediately after the hospital stay
measure: Changes in Maximal Grip Strength
timeFrame: At 12 weeks at the hospital discharge
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences, University of Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References: