Promotion of Active Lifestyle in Thromboembolism Patients

NCT06206967 | Unknown

• 1 other identifier: DF0099UG
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Thromboembolism

Keywords

Pulmonary Thromboembolism; Rehabilitation; Activity Promotion

Outcome Measures

Primary Outcomes (8)

• Changes in discapacity

  Changes in self-perceived discapacity were measured using the World Health Organization Disability Assessment Schedule, WHODAS 2.0, which provides a global measure of disability and 7 domain-specific scores.

  Baseline

• Changes in discapacity

  Changes in self-perceived discapacity were measured using the World Health Organization Disability Assessment Schedule, WHODAS 2.0, which provides a global measure of disability and 7 domain-specific scores. The punctuation range from 36 to 144, and higher score indicate higher disability, worse.

  Immediately after the hospital stay

• Changes in discapacity

  Changes in self-perceived discapacity were measured using the World Health Organization Disability Assessment Schedule, WHODAS 2.0, which provides a global measure of disability and 7 domain-specific scores. The punctuation range from 36 to 144, and higher score indicate higher disability, worse.

  At 12 weeks at the hospital discharge

• Quality of life measure with EuroQol-5D-5L

  Changes in quality of life were measured using the Euroqol 5dimensions which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. It also includes a visual analogue scale to report the health status from 0 to 100.

  Baseline

• Quality of life measure with EuroQol-5D-5L

  Changes in quality of life were measured using the Euroqol 5dimensions which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. It also includes a visual analogue scale to report the health status from 0 to 100.

  Immediately after the hospital stay

• Quality of life measure with EuroQol-5D-5L

  Changes in quality of life were measured using the Euroqol 5dimensions which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. It also includes a visual analogue scale to report the health status from 0 to 100.

  At 12 weeks at the hospital discharge

• Physical Activity Levels measured wit IPAQ

  The International Physical Activity Questionnaire (IPAQ) was developed to measure health-related physical activity (PA) in populations. The activities are classified as vigorous, moderate and walking, and total METs are calculated. NO minimum or maximum valors are stablished. Higher scores indicates higher physical activity levels. Better.

  Baseline

• Physical Activity Levels measured wit IPAQ

  The International Physical Activity Questionnaire (IPAQ) was developed to measure health-related physical activity (PA) in populations. The activities are classified as vigorous, moderate and walking, and total METs are calculated. NO minimum or maximum valors are stablished. Higher scores indicates higher physical activity levels. Better.

  At 12 weeks at the hospital discharge

Secondary Outcomes (20)

• Dyspnoea

  Baseline

• Dyspnoea

  Immediately after the hospital stay

• Dyspnoea

  At 12 weeks at the hospital discharge

• Changes in Psycho-emotional status

  Baseline

• Changes in Psycho-emotional status

  Hospital Discharge

Study Arms (2)

Physical Activity Promotion Group

EXPERIMENTAL

The rehabilitation program has the purpose of motivating patients to be more physically active. The treatment protocol had a total duration of 12 weeks. Three sessions are conducted during hospitalization for the education of patients and to start physical activity. A diary is provided to patients to record the activities that they perform during each week until completing the 12 weeks. Additionally, phone calls are performed at 15 days, 1 and 2 months to motivate patients and answer any questions they may have.

Other: Physical Activity Promotion

Control group

ACTIVE COMPARATOR

Patients received an informational brochure in a consultation with a health professional. The brochure explained the importance of physical activity to improve the health condition of these patients. Patients had the opportunity to ask any questions to the healthcare professional.

Other: Control Intervention

Interventions

Physical Activity Promotion OTHER

This intervention includes a hospital-based and a home-based intervention. During the hospital stay, the patients were provided with a health education which included information about thromboembolism pathophysiology and its management, healthy-lifestyle habits, benefits of early-mobilisation, and any questions patients may have would be answered. Additionally, an early-mobilization program is provided, which includes resistance and aerobic exercise. At the end of the hospital stay, a diary is provided to patients for recording the physical activity that performing the following 3 months. This diary is accompanied by phone calls at 15 days, 1 and 2 months of the hospital stay. During the phone calls, patients are motivated to increase their activity levels, and any questions patients may have, are answered.

Also known as: Motivation for being more physically active

Physical Activity Promotion Group

Control Intervention OTHER

Patients received an informational brochure in a consultation with a health professional. The brochure explained the importance of physical activity to improve the health condition of these patients. Patients had the opportunity to ask any questions to the healthcare professional.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences, University of Granada

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marie Carmen Valenza, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Carmen Valenza, PhD

CONTACT

958 248035; cvalenza@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNIVERSITY PROFESSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: January 16, 2024
• Study Start: January 20, 2024
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

ES (1)