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

June 22, 2012 updated by: Nathalia Suarez, CES University

Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD in an Institution Health Service Provider in the Department of Antioquia

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Physiotherapy
Group of participants who recive physiotherapy treatment using Kabat technique for the upper limbs resistance training during 12 weeks

The physiotherapeutic intervention was based on the Kabat (PNF) technique. Thirty-three sessions were planed. Each session lasted between thirty and fifty minutes.

The experimental group was guided by a physiotherapist or a physiotherapy student and each session took place in a hospital auditorium provided with oxygen cylinders, chairs and water.

Each session consisted of a warm up and stretch period, a period of resistance training of the upper limbs with their rest periods in which diaphragmatic breathing exercises and finally a cooling period.

The instructions and instruments given to each participant such as weights and elastic bands were the same for all of them.

OTHER: Yoga
Group of participants who recive Yoga sessions during 12 weeks

The intervention for the other group was the Yoga technique. Thirty-six sessions were planed. Each session was based on breathing, relaxation, and stretching exercises. Each session lasted between thirthy and forty minutes.

The group was led by a Yoga Instructor and each sessions took place in a hospital auditorium provided by oxygen cylinders, chairs and water.

No instruments were needed for this intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea degree
Time Frame: 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.
Up to 12 weeks
Aerobic capacity
Time Frame: 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.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Nathalia Suarez, Profesional, Professor CES University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

October 14, 2011

First Posted (ESTIMATE)

October 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2012

Last Update Submitted That Met QC Criteria

June 22, 2012

Last Verified

June 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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