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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02103400
Other study ID # CAP2014
Secondary ID
Status Completed
Phase N/A
First received March 22, 2014
Last updated March 30, 2016
Start date March 2014
Est. completion date February 2015

Study information

Verified date March 2016
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial Summary

Hospitalized patients with community-acquired pneumonia (CAP) have reduced functional capacity, peripheral muscle strength and quality of life. Despite the high incidence and severity has not yet been demonstrated whether a physical training program can change these outcomes. Objectives: To evaluate the effects of an exercise training program in patients hospitalized for CAP, to compare this effects with traditional physical therapy and assess whether the inflammatory markers correlate with the functional status of the patient and type of treatment. Methods: A controlled, prospective, randomized clinical trial. Patients hospitalized for CAP, adults, conscious, hemodynamically stable and independent to walk will be studied. In the first day, a medical history, measured dyspnea, incremental shuttle walk test, Glittre test, measurement of peripheral muscle strength, spirometry, and the application of quality of life questionnaire Shor Form 36 will be held. The measurement of inflammatory markers (C-reactive protein and tumor necrosis factor) will also be held. Patients will be randomized into two groups: one will perform a program of physical training (stretching, active resistance exercises and aerobic exercises) and the other group held the traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight days. On the tenth day the same assessment will be carried out initially described.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of pneumonia

- Must be able to walk

- Time less than 48 hours of hospitalization

- Age above 18 years

- Conscious and oriented

- Hemodynamically stable

Exclusion Criteria:

- Patients with other respiratory diseases

- Osteoarticular or cognitive disorders

- Patients who refuse to participate or complete the procedures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Experimental group
Exercise Training Group
Control group
Exercise control group

Locations

Country Name City State
Brazil Universidade Nove de Julho São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glittre test up to 9 months Yes
Secondary Shuttle test up to 9 months Yes
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