Promotion of Active Lifestyle in Thromboembolism Patients

NCT ID: NCT06206967

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Physical Activity Promotion Group

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.

Group Type: EXPERIMENTAL

Physical Activity Promotion

Intervention Type: 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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Control Intervention

Intervention Type: 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.

Interventions

Physical Activity Promotion

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.

Intervention Type: OTHER

Control Intervention

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.

Intervention Type: OTHER

Other Intervention Names

Motivation for being more physically active

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Marie Carmen Valenza

UNIVERSITY PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Carmen Valenza, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Faculty of Health Sciences, University of Granada

Granada, , Spain

Countries

Spain

Central Contacts

Marie Carmen Valenza, PhD

Role: CONTACT

cvalenza@ugr.es

958 248035

Facility Contacts

Marie Carmen Valenza, PhD

Role: primary

cvalenza@ugr.es

958 248035

Other Identifiers

DF0099UG

Identifier Type: -

Identifier Source: org_study_id