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

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ClinicalTrials.gov Identifier: NCT03100214
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Exercise Other: Control Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of an Early Rehabilitation Program During Hospitalization in Adolescents and Adults Patients With Cystic Fibrosis: Randomized Clinical Trial
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: 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

Experimental: 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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100214


Contacts
Contact: Josani S Flores, Master 5551984226290 josiflores@hotmail.com
Contact: Bruna Ziegler, PhD 5551991221192 brunaziegler@yahoo.com.br

Locations
Brazil
Paulo de Tarso Dalcin Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Contact: Paulo de Tarso R Dalcin, PhD       pdalcin@terra.com.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Director: Paulo de Tarso R Dalcin, PhD Hospital de Clínicas de Porto Alegre

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03100214     History of Changes
Other Study ID Numbers: 150443
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases