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

Cystic Fibrosis Clinical Trial

Official title:

Effects of an Early Rehabilitation Program During Hospitalization in Adolescents and Adults Patients With Cystic Fibrosis: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100214
• Other study ID #: 150443
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: May 1, 2019

Study information

• Verified date: March 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Exercise
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.
• Control
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

Locations

Country	Name	City	State
Brazil	Paulo de Tarso Dalcin	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance walked during the six minute walk test	The six-minute walk test will be performed at hospital discharge.	up to 14 days
Secondary	Forced expiratory volume in the first second	The spirometry will be performed at hospital discharge.	up to 14 days
Secondary	Cystic fibrosis quality of life questionary	Cystic fibrosis quality of life questionary will be performed at hospital discharge.	up to 14 days
Secondary	C-reative protein	C-reative protein will be performed at hospital discharge.	up to 14 days
Secondary	Interleukin-6	Interleukin-6 will be performed at hospital discharge.	up to 14 days
Secondary	Interleukin-8	Interleukin-8 will be performed at hospital discharge.	up to 14 days
Secondary	Tumor necrosis factor	Tumor necrosis factor will be performed at hospital discharge.	up to 14 days