Program Of Exercises During The Hospitalization Of Children And Adolescents With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Effects Of An Exercise Program During The Hospitalization Of Children And Adolescents With Cystic Fibrosis: Randomized Clinical Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03273959
• Other study ID #: 16-0126
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2017
• Last updated: September 4, 2017
• Start date: August 28, 2017
• Est. completion date: March 28, 2019

Study information

• Verified date: August 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Bruna Ziegler
• Phone: 5551991221192
• Email: brunaziegler[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 28, 2019
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis in Children
• Cystic Fibrosis Pulmonary Exacerbation
• Cystic Fibrosis With Exacerbation
• Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• Exercise protocol
Protocol of exercises performed in hospital admission in children and adolescents with cystic fibrosis in the exacerbation phase.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity	Evaluate the distance covered by the six-minute walk test	14 days
Secondary	Pulmonary functional capacity	Spirometry	14 days
Secondary	Physical fitness and health	Generate a score.	14 days
Secondary	Clinical score Shwachman-Kulczycki	Scoring for general activity, physical examination, nutrition and radiological findings of the thorax.	14 days
Secondary	bacteriology	The last bacteriological exams will be noted	14 days
Secondary	Nutrition assessment	Body mass index	14 days