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

NCT03100214 | Completed

• 1 other identifier: 150443
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Distance walked during the six minute walk test

  The six-minute walk test will be performed at hospital discharge.

  up to 14 days

Secondary Outcomes (6)

• Forced expiratory volume in the first second

  up to 14 days

• Cystic fibrosis quality of life questionary

  up to 14 days

• C-reative protein

  up to 14 days

• Interleukin-6

  up to 14 days

• Interleukin-8

  up to 14 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Other: Control

Exercise

EXPERIMENTAL

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.

Other: Exercise

Interventions

Exercise OTHER

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.

Exercise

Control OTHER

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

Control

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Paulo de Tarso Dalcin

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paulo de Tarso R Dalcin, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: April 4, 2017
• Study Start: August 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-03

Locations

BR (1)