Rehabilitation of Patients With Lung Chronic Obstructive Pulmonary Disease

NCT02468635 | Unknown

• 1 other identifier: ca141078
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is characterized by the obstruction is not fully reversible airway, where the severity of the disease and the prognosis is not determined solely by changes in lung function. Pulmonary rehabilitation is a multidisciplinary program of care for patients with chronic respiratory diseases, individually designed to optimize physical and social performance and autonomy of these patients, promoting improvement in functional exercise capacity, quality of life, reducing dyspnea, frequency and duration of hospitalizations and reduce the frequency of exacerbations of the disease. The overall objective of the research is to evaluate the effects of pulmonary rehabilitation program on exercise capacity, lung function, quality of daily life and reduction of dyspnea in patients with COPD. A study type randomized, open-label trial following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials) will be held. The study will be conducted at the Clinic Physiotherapy Course of the School with a sample of 58 patients. The intervention will be performed sessions three times a week for 16 weeks (8 weeks for assessment and 8 weeks for adaptation and (pulmonary rehabilitation training). The PR (pulmonary rehabilitation) will last 60-120 minutes each.O group A (control) will receive treatment of traditional pulmonary rehabilitation and without resistive training for upper limb (UL) and group B will receive the same treatment control with additional training of upper limb strength.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary rehabilitation; chronic obstructive pulmonary disease; physical ability; pulmonary function; quality of daily life

Outcome Measures

Primary Outcomes (1)

• Change in distance of the six-minute walk test

  measure: metres

  8 weeks

Secondary Outcomes (5)

• Change in quality of life

  8 weeks

• Change in forced expiratory volume in one second

  8 weeks

• Change in forced vital capacity

  8 weeks

• Change in respiratory muscle strength

  8 weeks

• repetition maximum (RM);

  8 weeks

Study Arms (2)

without training for upper limb

OTHER

Receive treatment from traditional pulmonary rehabilitation and without resistive training for upper limb (UL)

Other: without training for upper limb

upper limb exercises

OTHER

Receive the same treatment control with additional upper limb resistance training.

Other: upper limb exercises

Interventions

upper limb exercises OTHER

HEATING PHASE: diagonals for upper and lower limbs (5-10 minutes). AEROBIC PHASE: aerobic exercise on a treadmill or bicycle between 5 - 30 minutes and rest 1-2 minutes according to the Borg scale and patient tolerance (Borg scores for dyspnea 4-5); RESISTANCE STAGE: upper limb exercises with weight training equipment or dumbbells (the patient's adaptation) with 50% of maximum load reached the maximum repetition test. Series 2 minutes and rest interval between sets 1-2 minutes. RESPIRATORY TRAINING : Strengthening of the respiratory muscles 5-15 minutes with Threshold with load of 50% of the affected MIP (measure maximal inspiratory pressure) evaluation. RELAXATION: Stretching and muscle massage therapy group involved in the 5-10 minute workout.

upper limb exercises

without training for upper limb OTHER

HEATING PHASE: diagonals for upper and lower limbs (5-10 minutes). AEROBIC PHASE: aerobic exercise on a treadmill or bicycle between 5 - 30 minutes and rest 1-2 minutes according to the Borg scale and patient tolerance (Borg scores for dyspnea 4-5); RESPIRATORY TRAINING: Strengthening respiratory muscles 5-15 minutes with Threshold with load of 50% of MIP hit in the evaluation. RELAXATION: Stretching and muscle massage therapy group involved in the 5-10 minute workout.

without training for upper limb

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with COPD eligible to moderate COPD according to the criteria of gold GOLD (Global Initiative for Chronic Obstructive Lung Disease) and who had post-bronchodilator spirometry results in the last year of FEV1 (forced expiratory volume in one second) / FVC (forced vital capacity) \<0.7 and FEV1 between 50% and 80% of previsto.
• Besides being former smokers for at least three months and were clinically stable, no disease exacerbation in the past three months.
• Accompanied by a pulmonologist.
• Age between 40-85 years.
• They are not practicing physical activity.
• Without cardiovascular or orthopedic disease that makes it impossible to perform the exercises of the RP protocol.
• Without presenting other comorbidities that put them at risk during the exercises .
• Use of bronchodilators and oral theophylline, oxygen therapy or corticosteroids.

You may not qualify if:

• Patients who have musculoskeletal comorbidities that interfere with walking or performing upper extremity exercises.
• lower peripheral saturation decrease of oxygen lower than 90% during the 6 minute walk test (six) minutes.
• Presenting difficulty of cognitive understanding of body awareness and the ability to recall information for the questionnaire responses applied in the evaluation and re-evaluation in addition to this also children, adolescents and legally incapable

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Federal University of Bahia

Salvador, Estado de Bahia, 40110100, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adelmir Machado, research

  Federal University of Bahia

  STUDY DIRECTOR

Central Study Contacts

Cássio Magalhães, research

CONTACT

+557199616304; cassiofisio2@yahoo.com.br

Mansueto Neto, research

CONTACT

+557199188277; netofisio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2015
• First Posted: June 11, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

BR (1)