Program Of Exercises During The Hospitalization Of Children And Adolescents With Cystic Fibrosis
- Conditions
- Cystic Fibrosis Pulmonary ExacerbationCystic FibrosisCystic Fibrosis With ExacerbationCystic Fibrosis in Children
- Interventions
- Other: Exercise protocol
- Registration Number
- NCT03273959
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief Summary
The objective of this study was to evaluate the effect of a physical exercise program on the functional capacity of children and adolescents with cystic fibrosis hospitalized at the Hospital de Clínicas of Porto Alegre (HCPA) through a six-minute walk test using the distance traveled In six minutes.
In the first 48 hours of hospital stay, the following evaluations will be performed: Six-minute walk test, physical and health fitness test, spirometry and data collection. Patients will be randomized to either control group or intervention group. The control group will receive the conventional treatment offered by hospital care, the intervention group will receive this same treatment plus an exercise protocol. After 14 days they will be reevaluated with the same tests applied at the beginning of hospitalization.
- Detailed Description
The objective of the study is to evaluate the effect of a protocol of physical exercises on the functional capacity of children and adolescents with cystic fibrosis, hospitalized, in the stage of exacerbation of the disease.
In the first 48 hours of hospitalization patients and their caregivers will be invited to participate in the study. We will start with the following evaluations: Six-minute walk test, spirometry, physical fitness and health test (includes: walking, abdominal, flexibility and abdominal circumference), clinical score of shwachman kulczycki and Collected data from medical records.
After the initial evaluation the patient will be randomized to control group or intervention group. The control group will receive the conventional physiotherapy by the assistance team and the recreation service by the physical education. The intervention group will receive the same assistance plus the intervention with the exercise protocol five times a week supervised by a health professional. The exercise protocol includes: Punching, climbing and descending steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge, jumping on the floor ladder, cycling on the cycle ergometer and stretching.
At hospital discharge both groups will repeat the initial tests. The hypothesis is that the intervention group showed an improvement in functional capacity compared to the control group.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- They will be included in the study of patients from 6 to 18 years old, regularly followed by the Pediatric Pulmonology team of the HCPA, with diagnosis of cystic fibrosis according to the consensus criteria admitted to hospital admission due to exacerbation of the disease.
- Hospital admission is defined as a stay of 24 hours or more in any HCPA unit.
- An exacerbation of lung disease is defined as the presence of one or more of the following: Change in sputum volume and color, new or enlarged hemoptysis, increased cough, increased dyspnoea, malaise, fatigue, lethargy, fever, anorexia or Loss of weight, headache or pain in the sinuses, alteration of the pulmonary auscultation, non-FEV1 decrease of more than 10%, radiological, eradication of new bacteria.
- Patients with cardiac, orthopedic or trauma complications that make it impossible to perform the proposed exercises;
- Patients with hemodynamic instability, massive hemoptysis, pneumothorax, and continuous use of noninvasive ventilation.
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Exercise protocol Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive a program of physical exercises, illustrated in the form of a booklet and guided by a health professional. The patient is instructed to perform physical exercises five times a week until a hospital discharge. The participant will receive with a booklet a diary to write down the days in which to carry out the proposed exercises, in case of fault he will write down the reason for not performing. The exercise protocol includes: Punching, climbing and descending steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge, jumping on the floor ladder, cycling on the cycle ergometer and stretching.
- Primary Outcome Measures
Name Time Method Functional capacity 14 days Evaluate the distance covered by the six-minute walk test
- Secondary Outcome Measures
Name Time Method Pulmonary functional capacity 14 days Spirometry
Clinical score Shwachman-Kulczycki 14 days Scoring for general activity, physical examination, nutrition and radiological findings of the thorax.
bacteriology 14 days The last bacteriological exams will be noted
Physical fitness and health 14 days Generate a score.
Nutrition assessment 14 days Body mass index
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil