Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)

NCT00935181 | Completed Phase 4

• 1 other identifier: 3145/06
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The investigators studied the effects of respiratory muscle stretching in an 8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled trial, conducted an out-patient clinic. Twenty six patients with COPD (mean age 68 ± 6 y, percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise program that had 3 sessions per week. The investigators measured inspiratory and expiratory muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise capacity (by 6-minute walk distance), dyspnea and quality of life.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; diaphragm; muscle; stretching; exercises; dyspnea; respiratory muscle stretching; pulmonary rehabilitation; exercise training; improved exercise capacity, dyspnea, quality of life

Outcome Measures

Primary Outcomes (1)

• Inspiratory muscle strength

  2 hours

Secondary Outcomes (1)

• Exercise capacity

  2 hours

Study Arms (1)

exercise training program

EXPERIMENTAL

The exercise training program consisted of three 90-minute sessions per week for eight weeks. Each session consisted of a stretching exercise, resistance that patients started at 70% of the initial one-repetition maximum (1RM: the maximum load which can be moved only once over the full range of motion without compensatory movements) in the first week (3x8 repetitions). Every week the load was increased by 5% of the 1RM, and endurance training (treadmill walking speed was set at 60% of the average speed obtained from the 6MWT (6MWTpeak) for 10 mins in the first week and was increased to 20 mins in week 8

Behavioral: respiratory muscle stretching

Interventions

respiratory muscle stretching BEHAVIORAL

stretching exercises for respiratory muscles like diaphragm, pectoral, dorsalis etc

Also known as: pulmonary rehabilitation

exercise training program

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program
• With a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), in a stable condition (without exacerbations or infections for at least a month)
• Former smokers

You may not qualify if:

• Patients with a known history of asthma, or severe and/or unstable heart disease
• Any other pathological condition that could impair their physical activities

Sponsors & Collaborators

• Faculdade Evangelica do Parana: lead

Study Sites (1)

Faculdade Evangelica do Paraná

Curitiba, Paraná, 80730-000, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Dyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

• Silvia R. Valderramas, Ph.D

  Faculdade Evangelica do Paraná

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: July 8, 2009
• Study Start: January 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2008
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

BR (1)