Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; Dyspnea
• Interventions: Other: Physiotherapy; Other: Yoga

• Registration Number: NCT01452932
• Lead Sponsor: CES University

Brief Summary

Objective: To estimate the effectiveness of muscle training, the degree of dyspnea and aerobic capacity in patients over 50 with COPD, in a health care institution provider in Antioquia.

Question: What is the effectiveness of muscle training, in the degree of dyspnea and aerobic capacity in COPD patients over 50 years, in a health service institution provider in the department of Antioquia?

Hypothesis: Muscle training causes changes in the degree of dyspnea and aerobic capacity, other than the breathing exercises and relaxation

Design: Randomized clinical trial with allocation and blinding of the autcomes assesor.

Participants: COPD patients stage II and II, male and female, over 50 years old, who are attending to a community health service provider in the department of Antioquia.

Intervention: A physiotherapeutic intervention using PNF technique was applied to the experimental physiotherapy group versus Yoga sessions applied to the other group. Twelve weeks protocol performing three sessions per week.

Outcome measures: Dyspnea degree and aerobic capacity was measured using the MMRC scale and the six minute walking test respectively at the begining and the end of the study.

Detailed Description

Chronic obstructive pulmonary disease (COPD) is defined by GOLD (The Global Initiative for Chronic Obstructive Lung Disease) as a disease process characterized by progressive airflow limitation associated with an abnormal inflammatory response of the lungs to particles or harmful gases and is not fully reversible. This restriction generates an expiratory flow of air entrapment resulting hyperinflation, coupled with the effects that systemic, structural changes occur in skeletal muscles which leads to greater fatigue causing dyspnea. Consequently, patients with COPD require participation of accessory muscles of respiration, which should have a dual function during activities involving the upper limbs, to supply the ventilatory requirements and movements of the shoulder girdle, which increases dyspnea carrying the patient to stop their activities, leading to physical deconditioning and progressively decreasing aerobic capacity. This demonstrates the need to improve the resistance of the upper limb muscles in these patients, thus contributing to a reduction in the degree of dyspnea and improved their aerobic capacity. The investigators propose a study aimed at determining the effectiveness of muscle training in the degree of dyspnea and aerobic capacity in COPD.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-17
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-26
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Men and women over 50 years with a diagnosis of COPD stage II and III according to GOLD classification, performed spirometry
• Patients who manifest dyspnea on MRC
• Patients SGSS affiliates.
• COPD controlled, verified medical history
• Voluntary participation in informed consent

Exclusion Criteria

• Higher mental functions altered
• Degenerative musculoskeletal diseases (acute state)
• Multisystem disease not controlled
• Perform a current fitness program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiotherapy	Physiotherapy	Group of participants who recive physiotherapy treatment using Kabat technique for the upper limbs resistance training during 12 weeks
Yoga	Yoga	Group of participants who recive Yoga sessions during 12 weeks

Primary Outcome Measures

Name	Time	Method
Dyspnea degree	Up to 12 weeks	The degree of dyspnea is measured at baseline as one of the most important criteria for inclusion, after randomization of participants and past twelve weeks (duration of the intervention protocol) is measured this variable as a primary outcome.
Aerobic capacity	Up to 12 weeks	Aerobic capacity is measured with the six minutes walking test (6MWT) at baseline as one of the most important criteria for inclusion, performed after randomization of participants and past twelve weeks (duration of the intervention protocol) is measured this variable as a secondary outcome.