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

NCT ID: NCT03273959

Last Updated: 2017-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-28
• Study Completion Date: 2019-03-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type: EXPERIMENTAL

Exercise protocol

Intervention Type: OTHER

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

Interventions

Exercise protocol

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruna Ziegler

Role: STUDY_DIRECTOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Bruna Ziegler

Role: CONTACT

brunaziegler@yahoo.com.br

5551991221192

Taiane Feiten

Role: CONTACT

taifeiten@gmail.com

5551991539788

Facility Contacts

Bruna Ziegler

Role: primary

brunaziegler@yahoo.com.br

5551991221192

Taiane Feiten

Role: backup

taifeiten@gmail.com

5551991539788

Other Identifiers

16-0126

Identifier Type: -

Identifier Source: org_study_id