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Effects of an Early Rehabilitation Program During Hospitalization in Patients With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Control
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

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 16 years and older,
  • Regularly followed up in the Hospital de Clinicas de Porto Alegre Program for Adolescents and Adults with Cystic Fibrosis with a diagnosis of cystic fibrosis confirmed according to the consensus criteria,
  • Admitted to hospital admission due to exacerbation of lung disease.
  • Hospital stay will be defined as the stay equal to or greater than 24 hours in any Hospital de Clinicas de Porto Alegre unit.

Exclusion Criteria:

  • Patients with cardiac, orthopedic or trauma complications that make it impossible to perform the proposed exercises;
  • Pregnant patients;
  • Patients with hemodynamic instability, massive hemoptysis, pneumothorax, and continuous use of noninvasive ventilation.

Sites / Locations

  • Paulo de Tarso Dalcin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Exercise

Arm Description

Patients randomized to the control group will continue to receive the physiotherapeutic follow-up performed by the physiotherapist of the Program for Adults with CF during the hospitalization period. Supervision includes respiratory physiotherapy involving inhalation therapy and techniques for removal of secretions.

Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive an early rehabilitation program, which will begin within the first 48 hours after admission. The patient will perform physical training (aerobic and anaerobic) 5 times a week during the hospitalization period, with sessions about an hour. The professional who supervises the training will be blinded to the results of the measurements.

Outcomes

Primary Outcome Measures

Distance walked during the six minute walk test
The six-minute walk test will be performed at hospital discharge.

Secondary Outcome Measures

Forced expiratory volume in the first second
The spirometry will be performed at hospital discharge.
Cystic fibrosis quality of life questionary
Cystic fibrosis quality of life questionary will be performed at hospital discharge.
C-reative protein
C-reative protein will be performed at hospital discharge.
Interleukin-6
Interleukin-6 will be performed at hospital discharge.
Interleukin-8
Interleukin-8 will be performed at hospital discharge.
Tumor necrosis factor
Tumor necrosis factor will be performed at hospital discharge.

Full Information

First Posted
January 31, 2017
Last Updated
May 10, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03100214
Brief Title
Effects of an Early Rehabilitation Program During Hospitalization in Patients With Cystic Fibrosis
Official Title
Effects of an Early Rehabilitation Program During Hospitalization in Adolescents and Adults Patients With Cystic Fibrosis: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Studies demonstrate that exercise increases the maximal oxygen uptake, peak oxygen consumption, reduce effort-induced lactic acid production, and increase skeletal muscle oxidative capacity, as well as psychological aspects such as increased self-esteem and improvement of the quality of life. In the literature there is only one study involving rehabilitation in hospitalized pediatric patients with cystic fibrosis. Thus, more information on in-hospital rehabilitation is required in adult cystic fibrosis patients. The present study aims to evaluate the effects of an early rehabilitation program, based on aerobic training and muscle strength training, in adolescent and adult patients with cystic fibrosis hospitalized at Hospital de Clinicas de Porto Alegre for exacerbation of lung disease.
Detailed Description
After completing the study inclusion criteria, the individual will be invited to participate and will receive the consent form for signature. The patient will be submitted to the following evaluations: quality of life questionnaire for cystic fibrosis, spirometry, Shwachman-Kulczycki score, modified dyspnea questionnaire (Modified Medical Research Council), maximum repetition test, six minute walk test and blood sample for the determination of inflammatory markers. These evaluations should be performed within the first 48 hours of hospitalization, and will be repeated on the last day of hospitalization. In the period up to 48 hours after hospital admission, patients will be randomized to either the intervention group or the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients randomized to the control group will continue to receive the physiotherapeutic follow-up performed by the physiotherapist of the Program for Adults with CF during the hospitalization period. Supervision includes respiratory physiotherapy involving inhalation therapy and techniques for removal of secretions.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive an early rehabilitation program, which will begin within the first 48 hours after admission. The patient will perform physical training (aerobic and anaerobic) 5 times a week during the hospitalization period, with sessions about an hour. The professional who supervises the training will be blinded to the results of the measurements.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive an early rehabilitation program, which will begin within the first 48 hours after admission. The patient will perform physical training (aerobic and anaerobic) 5 times a week during the hospitalization period, with sessions about an hour. The professional who supervises the training will be blinded to the results of the measurements.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Patients randomized to the control group will continue to receive the physiotherapeutic follow-up performed by the physiotherapist of the Program for Adults with CF during the hospitalization period. Supervision includes respiratory physiotherapy involving inhalation therapy and techniques for removal of secretions
Primary Outcome Measure Information:
Title
Distance walked during the six minute walk test
Description
The six-minute walk test will be performed at hospital discharge.
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
Forced expiratory volume in the first second
Description
The spirometry will be performed at hospital discharge.
Time Frame
up to 14 days
Title
Cystic fibrosis quality of life questionary
Description
Cystic fibrosis quality of life questionary will be performed at hospital discharge.
Time Frame
up to 14 days
Title
C-reative protein
Description
C-reative protein will be performed at hospital discharge.
Time Frame
up to 14 days
Title
Interleukin-6
Description
Interleukin-6 will be performed at hospital discharge.
Time Frame
up to 14 days
Title
Interleukin-8
Description
Interleukin-8 will be performed at hospital discharge.
Time Frame
up to 14 days
Title
Tumor necrosis factor
Description
Tumor necrosis factor will be performed at hospital discharge.
Time Frame
up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 16 years and older, Regularly followed up in the Hospital de Clinicas de Porto Alegre Program for Adolescents and Adults with Cystic Fibrosis with a diagnosis of cystic fibrosis confirmed according to the consensus criteria, Admitted to hospital admission due to exacerbation of lung disease. Hospital stay will be defined as the stay equal to or greater than 24 hours in any Hospital de Clinicas de Porto Alegre unit. Exclusion Criteria: Patients with cardiac, orthopedic or trauma complications that make it impossible to perform the proposed exercises; Pregnant patients; Patients with hemodynamic instability, massive hemoptysis, pneumothorax, and continuous use of noninvasive ventilation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo de Tarso R Dalcin, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Paulo de Tarso Dalcin
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of an Early Rehabilitation Program During Hospitalization in Patients With Cystic Fibrosis

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