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Pulmonary ThromboembolismACTIVATEPNCT06206967

Promotion of Active Lifestyle in Thromboembolism Patients

A study testing Physical Activity Promotion in people with Pulmonary Thromboembolism, run by Universidad de Granada at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Thromboembolism
What is being tested?
Physical Activity Promotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSpain
Study dates
20 Jan 2024to Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Marie Carmen Valenza, PhD contact

958 248035

cvalenza@ugr.es

Spain1 site
  • Faculty of Health Sciences, University of Granada

    Granada, 18071

    Marie Carmen Valenza, PhD, 958 248035, cvalenza@ugr.es

Other trials in Spain

About this study

Official title: Rehabilitation Program for Promotion Active Lifestyle After Suffering a Pulmonary Thromboembolism

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.

Being tested
Physical Activity Promotion, Control Intervention
Keywords
Pulmonary Thromboembolism, Rehabilitation, Activity Promotion
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity PromotionOther

    Also called Motivation for being more physically active

    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 InterventionOther

    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.

Study groups in NCT06206967
Study groupRoleWhat they receive
Physical Activity Promotion GroupExperimentalThe 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.
Receives: Other: Physical Activity Promotion
Control groupActive comparatorPatients 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.
Receives: Other: Control Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Immediately after the hospital stay

  3. 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.

    Measured: At 12 weeks at the hospital discharge

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Immediately after the hospital stay

  6. 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.

    Measured: At 12 weeks at the hospital discharge

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: At 12 weeks at the hospital discharge

Secondary outcomes (20)
  1. Dyspnoea

    The perceived dyspnoea is measure with the Borg Scale. This scale in range from 0-10, where higher score indicate higher levels of dyspnoea. Worse.

    Measured: Baseline

  2. Dyspnoea

    The perceived dyspnoea is measure with the Borg Scale. This scale in range from 0-10, where higher score indicate higher levels of dyspnoea. Worse.

    Measured: Immediately after the hospital stay

  3. Dyspnoea

    The perceived dyspnoea is measure with the Borg Scale. This scale in range from 0-10, where higher score indicate higher levels of dyspnoea. Worse.

    Measured: At 12 weeks at the hospital discharge

  4. Changes in Psycho-emotional status

    The DASS-21 scale asks respondents to answer 21 questions focused on experiencing symptoms of depression, anxiety, and stress in the past week.

    Participants were provided four response options: 0=never, 1=sometimes, 2=a lot of the time, 3=most or all of the time. Higher response values, and higher scores, indicate higher levels of experiencing the condition measured.

    Measured: Baseline

  5. Changes in Psycho-emotional status

    The DASS-21 scale asks respondents to answer 21 questions focused on experiencing symptoms of depression, anxiety, and stress in the past week.

    Participants were provided four response options: 0=never, 1=sometimes, 2=a lot of the time, 3=most or all of the time. Higher response values, and higher scores, indicate higher levels of experiencing the condition measured.

    Measured: Hospital Discharge

  6. Changes in Psycho-emotional status

    The DASS-21 scale asks respondents to answer 21 questions focused on experiencing symptoms of depression, anxiety, and stress in the past week.

    Participants were provided four response options: 0=never, 1=sometimes, 2=a lot of the time, 3=most or all of the time. Higher response values, and higher scores, indicate higher levels of experiencing the condition measured.

    Measured: At 12 weeks at the hospital discharge

  7. Changes in Performance status

    The performance status is measure with the Canadian Occupational Performance Measure. In a semi structured interview, the patient is encouraged to discuss areas of activity that may present problems that they may need to, want to, or are expected to carry out on a regular basis. These problem areas are then rated in terms of importance to the patient´s life using the rating scale from 1 - 10, where 1 = not at all important, and 10 = extremely important to the client. The five most important problems are then the focus of intervention and the outcome measurement. The patient, using a similar scale, is then asked to rate his/her perception of performance and satisfaction with this performance in the selected problem areas. The two scores are separately summed and divided by the number of problem areas, giving the mean foreach.

    Measured: Baseline

  8. Changes in Performance status

    The performance status is measure with the Canadian Occupational Performance Measure. In a semi structured interview, the patient is encouraged to discuss areas of activity that may present problems that they may need to, want to, or are expected to carry out on a regular basis. These problem areas are then rated in terms of importance to the patient´s life using the rating scale from 1 - 10, where 1 = not at all important, and 10 = extremely important to the client. The five most important problems are then the focus of intervention and the outcome measurement. The patient, using a similar scale, is then asked to rate his/her perception of performance and satisfaction with this performance in the selected problem areas. The two scores are separately summed and divided by the number of problem areas, giving the mean foreach.

    Measured: Immediately after the hospital stay

  9. Changes in Performance status

    The performance status is measure with the Canadian Occupational Performance Measure. In a semi structured interview, the patient is encouraged to discuss areas of activity that may present problems that they may need to, want to, or are expected to carry out on a regular basis. These problem areas are then rated in terms of importance to the patient´s life using the rating scale from 1 - 10, where 1 = not at all important, and 10 = extremely important to the client. The five most important problems are then the focus of intervention and the outcome measurement. The patient, using a similar scale, is then asked to rate his/her perception of performance and satisfaction with this performance in the selected problem areas. The two scores are separately summed and divided by the number of problem areas, giving the mean foreach.

    Measured: At 12 weeks at the hospital discharge

  10. Changes in Breathlessness Beliefs

    The Breathlessness Beliefs Questionnaire (BBQ) is a concise 10-item self-report assessment tool used in the realm of respiratory health. It gauges an individual's perceptions and beliefs regarding breathlessness or dyspnea. Respondents rate their agreement with statements on a scale, often ranging from 0 to 10, reflecting their thoughts about the causes, consequences, and controllability of breathlessness. Higher scores may indicate more negative beliefs, while lower scores suggest more positive or adaptive beliefs. The BBQ aids in tailoring interventions and treatments for individuals with respiratory conditions, shedding light on the cognitive factors contributing to breathlessness-related distress and ultimately improving patient well-being and functional outcomes.

    Measured: Baseline

  11. Changes in Breathlessness Beliefs

    The Breathlessness Beliefs Questionnaire (BBQ) is a concise 10-item self-report assessment tool used in the realm of respiratory health. It gauges an individual's perceptions and beliefs regarding breathlessness or dyspnea. Respondents rate their agreement with statements on a scale, often ranging from 0 to 10, reflecting their thoughts about the causes, consequences, and controllability of breathlessness. Higher scores may indicate more negative beliefs, while lower scores suggest more positive or adaptive beliefs. The BBQ aids in tailoring interventions and treatments for individuals with respiratory conditions, shedding light on the cognitive factors contributing to breathlessness-related distress and ultimately improving patient well-being and functional outcomes.

    Measured: Immediately after the hospital stay

  12. Changes in Breathlessness Beliefs

    The Breathlessness Beliefs Questionnaire (BBQ) is a concise 10-item self-report assessment tool used in the realm of respiratory health. It gauges an individual's perceptions and beliefs regarding breathlessness or dyspnea. Respondents rate their agreement with statements on a scale, often ranging from 0 to 10, reflecting their thoughts about the causes, consequences, and controllability of breathlessness. Higher scores may indicate more negative beliefs, while lower scores suggest more positive or adaptive beliefs. The BBQ aids in tailoring interventions and treatments for individuals with respiratory conditions, shedding light on the cognitive factors contributing to breathlessness-related distress and ultimately improving patient well-being and functional outcomes.

    Measured: At 12 weeks at the hospital discharge

  13. Changes in managing the own healthcare

    The Patient Activation Measure-13 (PAM-13) is a concise assessment tool designed to evaluate an individual's knowledge, skills, and confidence in managing their own healthcare. Comprising 13 items, this self-report questionnaire helps healthcare professionals and researchers gauge a patient's level of activation and engagement in their healthcare journey. Respondents answer a series of questions related to their health-related knowledge, confidence in managing their health, and their proactivity in seeking healthcare information and making informed decisions. Higher PAM-13 scores indicate a higher level of patient activation, which is often associated with better health outcomes and more effective self-management of chronic conditions. This tool plays a crucial role in tailoring patient education and support strategies.

    Measured: Immediately after the hospital stay

  14. Changes in managing the own healthcare

    The Patient Activation Measure-13 (PAM-13) is a concise assessment tool designed to evaluate an individual's knowledge, skills, and confidence in managing their own healthcare. Comprising 13 items, this self-report questionnaire helps healthcare professionals and researchers gauge a patient's level of activation and engagement in their healthcare journey. Respondents answer a series of questions related to their health-related knowledge, confidence in managing their health, and their proactivity in seeking healthcare information and making informed decisions. Higher PAM-13 scores indicate a higher level of patient activation, which is often associated with better health outcomes and more effective self-management of chronic conditions. This tool plays a crucial role in tailoring patient education and support strategies.

    Measured: At 12 weeks at the hospital discharge

  15. Changes in physical functioning

    The physical functioning is measured using the "Short Physical Performance Battery" (SPPB). To assess usual walking speed (meters/second), the participants were asked to walk 4 metro at their regular pace twice from a standing position. The standing balance tests included side-by-side, semi-tandem, and full-tandem standing, and the participants were timed until they moved, or 10 s had elapsed. To assess the 5-times sit-to-stand test, the participants were asked to perform five chair stands as quickly as possible. Time (in seconds) was registered with a stopwatch with a resolution of 0.01 s. The total score ranged from 0 (worst) to 12 points (best). An increase of 1-point is recommended in disability research.

    Measured: Baseline

  16. Changes in physical functioning

    The physical functioning is measured using the "Short Physical Performance Battery" (SPPB). To assess usual walking speed (meters/second), the participants were asked to walk 4 metro at their regular pace twice from a standing position. The standing balance tests included side-by-side, semi-tandem, and full-tandem standing, and the participants were timed until they moved, or 10 s had elapsed. To assess the 5-times sit-to-stand test, the participants were asked to perform five chair stands as quickly as possible. Time (in seconds) was registered with a stopwatch with a resolution of 0.01 s. The total score ranged from 0 (worst) to 12 points (best). An increase of 1-point is recommended in disability research.

    Measured: Immediately after the hospital stay

  17. Changes in physical functioning

    The physical functioning is measured using the "Short Physical Performance Battery" (SPPB). To assess usual walking speed (meters/second), the participants were asked to walk 4 metro at their regular pace twice from a standing position. The standing balance tests included side-by-side, semi-tandem, and full-tandem standing, and the participants were timed until they moved, or 10 s had elapsed. To assess the 5-times sit-to-stand test, the participants were asked to perform five chair stands as quickly as possible. Time (in seconds) was registered with a stopwatch with a resolution of 0.01 s. The total score ranged from 0 (worst) to 12 points (best). An increase of 1-point is recommended in disability research.

    Measured: At 12 weeks at the hospital discharge

  18. Changes in Maximal Grip Strength

    Maximal grip strength was assessed using a Jamar hydraulic hand dynamometer. The participant was told to squeeze it as hard as possible and then release. This procedure was repeated three times with each hand alternating between both hands with 5 minutes rest between the trials. The grip strength was recorded in kg and the highest of the three trials was used.

    Measured: Baseline

  19. Changes in Maximal Grip Strength

    Maximal grip strength was assessed using a Jamar hydraulic hand dynamometer. The participant was told to squeeze it as hard as possible and then release. This procedure was repeated three times with each hand alternating between both hands with 5 minutes rest between the trials. The grip strength was recorded in kg and the highest of the three trials was used.

    Measured: Immediately after the hospital stay

  20. Changes in Maximal Grip Strength

    Maximal grip strength was assessed using a Jamar hydraulic hand dynamometer. The participant was told to squeeze it as hard as possible and then release. This procedure was repeated three times with each hand alternating between both hands with 5 minutes rest between the trials. The grip strength was recorded in kg and the highest of the three trials was used.

    Measured: At 12 weeks at the hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start20 Jan 2024 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06206967
Sponsor's protocol ID
DF0099UG
Acronym
ACTIVATEP
Status last verified
Jan 2024
First submitted
15 Nov 2023
Last updated
16 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Promotion in people with Pulmonary Thromboembolism, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marie Carmen Valenza, PhD (958 248035, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in discapacity (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.

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