Cystic Fibrosis, Cystic Fibrosis in Children, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis With Exacerbation
Conditions
Keywords
Physiotherapy, Physical Therapy, Exercise, Hospitalization, Pediatric, Adolescents
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.
Interventions
OTHERExercise protocol
Protocol of exercises performed in hospital admission in children and adolescents with cystic fibrosis in the exacerbation phase.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The evaluator who will apply the tests at the beginning and end of the hospital stay will be blinded. The evaluator who will apply the tests at the beginning and end of the hospital stay will be blinded. Another health professional who will participate in the research will apply the protocol of supervised exercises in patients who are randomized to the intervention group.
Intervention model description
Patients will be randomized into two groups: control and intervention.
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity | 14 days | Evaluate the distance covered by the six-minute walk test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary functional capacity | 14 days | Spirometry |
| Physical fitness and health | 14 days | Generate a score. |
| 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 |
| Nutrition assessment | 14 days | Body mass index |
Countries
Brazil
Contacts
Primary ContactBruna Ziegler
Backup ContactTaiane Feiten
Outcome results
None listed