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NCT Number: NCT03100214

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

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.

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Key information

Conditions

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

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paulo de Tarso Dalcin

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Distance walked during the six minute walk test

    Time frame: up to 14 days

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

Secondary outcomes

  1. Forced expiratory volume in the first second

    Time frame: up to 14 days

    The spirometry will be performed at hospital discharge.

  2. Cystic fibrosis quality of life questionary

    Time frame: up to 14 days

    Cystic fibrosis quality of life questionary will be performed at hospital discharge.

  3. C-reative protein

    Time frame: up to 14 days

    C-reative protein will be performed at hospital discharge.

  4. Interleukin-6

    Time frame: up to 14 days

    Interleukin-6 will be performed at hospital discharge.

  5. Interleukin-8

    Time frame: up to 14 days

    Interleukin-8 will be performed at hospital discharge.

  6. Tumor necrosis factor

    Time frame: up to 14 days

    Tumor necrosis factor will be performed at hospital discharge.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2017
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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