Rehabilitation Program for Promotion Active Lifestyle After Suffering a Pulmonary Thromboembolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Quality of life measure with EuroQol-5D-5L
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes.
- •Agreed to participate.
- •Thromboembolism patients meeting the diagnosis criteria for this disease.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Physical Activity Promotion (Other)
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.
干预措施: Control Intervention (Other)
结局指标
主要结局
Quality of life measure with EuroQol-5D-5L
时间窗: At 12 weeks at the hospital discharge
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.
Changes in discapacity
时间窗: At 12 weeks at the hospital discharge
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.
Physical Activity Levels measured wit IPAQ
时间窗: At 12 weeks at the hospital discharge
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.
Changes in discapacity
时间窗: Baseline
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.
Changes in discapacity
时间窗: Immediately after the hospital stay
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.
Quality of life measure with EuroQol-5D-5L
时间窗: Baseline
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.
Quality of life measure with EuroQol-5D-5L
时间窗: Immediately after the hospital stay
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.
Physical Activity Levels measured wit IPAQ
时间窗: Baseline
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.
次要结局
- Dyspnoea(At 12 weeks at the hospital discharge)
- Changes in Breathlessness Beliefs(At 12 weeks at the hospital discharge)
- Changes in managing the own healthcare(At 12 weeks at the hospital discharge)
- Changes in Psycho-emotional status(At 12 weeks at the hospital discharge)
- Changes in physical functioning(At 12 weeks at the hospital discharge)
- Changes in Performance status(At 12 weeks at the hospital discharge)
- Changes in Maximal Grip Strength(At 12 weeks at the hospital discharge)
- Dyspnoea(Baseline)
- Dyspnoea(Immediately after the hospital stay)
- Changes in Psycho-emotional status(Baseline)
- Changes in Psycho-emotional status(Hospital Discharge)
- Changes in Performance status(Baseline)
- Changes in Performance status(Immediately after the hospital stay)
- Changes in Breathlessness Beliefs(Baseline)
- Changes in Breathlessness Beliefs(Immediately after the hospital stay)
- Changes in managing the own healthcare(Immediately after the hospital stay)
- Changes in physical functioning(Baseline)
- Changes in physical functioning(Immediately after the hospital stay)
- Changes in Maximal Grip Strength(Baseline)
- Changes in Maximal Grip Strength(Immediately after the hospital stay)
研究者
Marie Carmen Valenza
UNIVERSITY PROFESSOR
Universidad de Granada