Clinical trial NCT03100214: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Distance walked during the six minute walk test
timeFrame: up to 14 days
Secondary outcomes:
measure: Forced expiratory volume in the first second
timeFrame: up to 14 days
measure: Cystic fibrosis quality of life questionary
timeFrame: up to 14 days
measure: C-reative protein
timeFrame: up to 14 days
measure: Interleukin-6
timeFrame: up to 14 days
measure: Interleukin-8
timeFrame: up to 14 days
measure: Tumor necrosis factor
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Paulo de Tarso Dalcin
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Paulo de Tarso R Dalcin, PhD
role: STUDY_DIRECTOR
References: