Impact of a Hospital Physical Therapy Program on Chronic Obstructive Pulmonary Disease (COPD) Patients

Universidade Federal de Sao Carlos

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Ground Walking Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01295359

DPOCexacaminhada

Details and patient eligibility

About

The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and mortality, so it's important to find actions that could improve quality of life and decrease the mortality. The objective of this study is to verify if a ground walking program applied to hospitalized exacerbated COPD patients has effects in quality of life, exercise capacity, airways obstruction, body composition, heart rate variability, quadriceps isometric force and in the "Body-mass index, Airway Obstruction, Dyspnea, Exercise Capacity index" (BODE index). An evaluators-blinded randomized controlled study will be conducted in "Hospital Escola Municipal de São Carlos" where forty patients will be recruited to participate. The volunteers will be randomized in two groups with twenty patients, the usual care group, that will receive only the usual care of the hospital; and the trained group that will receive the same care, but will also participate in a ground walking program associated with respiratory exercises. It will be evaluated, in the start and at the end of the program, the health related and general quality of life and the Barthel index. Daily, the patient will be submitted to the Six Minute Walk Test, to a body composition analysis, to a hand grip test and to a dyspnea assessment, and will be calculated its BODE index. All patients will be invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would receive the same evaluation of the last day in the hospital. All the collected data will be expressed in means and standard deviations or medians and range when appropriated. It will be chosen appropriated tests to compare and correlate them.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD Patients (FEV1/FVC < 0,70; FEV1 > 30% and < 80%)
• Hospitalized for exacerbation of COPD

Exclusion criteria

• Conditions that could restrict walking

  • Skeletal-muscle and joint disturbs
  • Extreme Obesity (BMI > 35kg/m²)

• Heart Failure (New York Heart Association class III and IV)

• Uncontrolled infection (fever > 38ºC and leukocytosis > 10000 cels/dl)

• Need of Invasive Mechanical Ventilation after the beginning of the program

• Previous Diagnosis of:

  • Stroke
  • Epilepsy

• Coagulation disorders (INR > 1,5 or platelets < 50.000/m³)

• Psychiatric Disorders or severe agitation

• Cardiac or respiratory instability

• Oxygen therapy > 3L/min at rest

• Respiratory Rate > 30 breaths/min at rest

• Tachycardia and Bradycardia

• Vasoactive Drugs need

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Trained Group

Experimental group

Description:

This group will receive the usual care of the hospital and a ground walking training program associated with respiratory exercises.

Treatment:

Other: Ground Walking Program

Usual Care Group

No Intervention group

Description:

This group will only receive the usual care of the hospital, including physical therapy