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

NCT03273959 | Unknown

• 1 other identifier: 16-0126
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Cystic Fibrosis in Children; Cystic Fibrosis Pulmonary Exacerbation; Cystic Fibrosis With Exacerbation

Keywords

Physiotherapy; Physical Therapy; Exercise; Hospitalization; Pediatric; Adolescents

Outcome Measures

Primary Outcomes (1)

• Functional capacity

  Evaluate the distance covered by the six-minute walk test

  14 days

Secondary Outcomes (5)

• Pulmonary functional capacity

  14 days

• Physical fitness and health

  14 days

• Clinical score Shwachman-Kulczycki

  14 days

• bacteriology

  14 days

• Nutrition assessment

  14 days

Study Arms (2)

Group control

NO INTERVENTION

Patients randomized to the control group will receive routine physiotherapeutic follow-up, performed by the physiotherapist of the hospital during the hospitalization period. Supervision includes inhalation therapy and respiratory physiotherapy. Respiratory exercises and thoracic maneuvers for bronchial hygiene will be performed, according to what the patient is accustomed to perform. Other techniques besides these can be added at the discretion of the physiotherapist according to the needs of the patient. In pediatric hospitalization patients also receive care from physical educators who associate recreational and recreational activities with the treatment.

Intervention group

EXPERIMENTAL

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.

Other: Exercise protocol

Interventions

Exercise protocol OTHER

Protocol of exercises performed in hospital admission in children and adolescents with cystic fibrosis in the exacerbation phase.

Intervention group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• Bruna Ziegler

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Central Study Contacts

Bruna Ziegler

CONTACT

5551991221192; brunaziegler@yahoo.com.br

Taiane Feiten

CONTACT

5551991539788; taifeiten@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into two groups: control and intervention.

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 6, 2017
• Study Start: August 28, 2017
• Primary Completion: August 28, 2018
• Study Completion: March 28, 2019
• Last Updated: September 6, 2017

Record last verified: 2017-08

Locations

BR (1)