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

Primary Purpose

Cystic Fibrosis, Cystic Fibrosis in Children, Cystic Fibrosis Pulmonary Exacerbation

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise protocol
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Physiotherapy, Physical Therapy, Exercise, Hospitalization, Pediatric, Adolescents

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group control

Intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Functional capacity
Evaluate the distance covered by the six-minute walk test

Secondary Outcome Measures

Pulmonary functional capacity
Spirometry
Physical fitness and health
Generate a score.
Clinical score Shwachman-Kulczycki
Scoring for general activity, physical examination, nutrition and radiological findings of the thorax.
bacteriology
The last bacteriological exams will be noted
Nutrition assessment
Body mass index

Full Information

First Posted
September 4, 2017
Last Updated
September 4, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03273959
Brief Title
Program Of Exercises During The Hospitalization Of Children And Adolescents With Cystic Fibrosis
Official Title
Effects Of An Exercise Program During The Hospitalization Of Children And Adolescents With Cystic Fibrosis: Randomized Clinical Test
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
August 28, 2018 (Anticipated)
Study Completion Date
March 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Cystic Fibrosis in Children, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis With Exacerbation
Keywords
Physiotherapy, Physical Therapy, Exercise, Hospitalization, Pediatric, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized into two groups: control and intervention.
Masking
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise protocol
Intervention Description
Protocol of exercises performed in hospital admission in children and adolescents with cystic fibrosis in the exacerbation phase.
Primary Outcome Measure Information:
Title
Functional capacity
Description
Evaluate the distance covered by the six-minute walk test
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Pulmonary functional capacity
Description
Spirometry
Time Frame
14 days
Title
Physical fitness and health
Description
Generate a score.
Time Frame
14 days
Title
Clinical score Shwachman-Kulczycki
Description
Scoring for general activity, physical examination, nutrition and radiological findings of the thorax.
Time Frame
14 days
Title
bacteriology
Description
The last bacteriological exams will be noted
Time Frame
14 days
Title
Nutrition assessment
Description
Body mass index
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruna Ziegler
Phone
5551991221192
Email
brunaziegler@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Taiane Feiten
Phone
5551991539788
Email
taifeiten@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruna Ziegler
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruna Ziegler
Phone
5551991221192
Email
brunaziegler@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Taiane Feiten
Phone
5551991539788
Email
taifeiten@gmail.com

12. IPD Sharing Statement

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

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