Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease, Dyspnea
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Physiotherapy
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Dyspnea, Exercise test, Endurance training
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Physiotherapy
Yoga
Arm Description
Group of participants who recive physiotherapy treatment using Kabat technique for the upper limbs resistance training during 12 weeks
Group of participants who recive Yoga sessions during 12 weeks
Outcomes
Primary Outcome Measures
Dyspnea degree
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01452932
First Posted
October 13, 2011
Last Updated
June 22, 2012
Sponsor
CES University
Collaborators
La ceja Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01452932
Brief Title
Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD
Official Title
Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD in an Institution Health Service Provider in the Department of Antioquia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CES University
Collaborators
La ceja Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Dyspnea
Keywords
Chronic obstructive pulmonary disease, Dyspnea, Exercise test, Endurance training
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy
Arm Type
Experimental
Arm Description
Group of participants who recive physiotherapy treatment using Kabat technique for the upper limbs resistance training during 12 weeks
Arm Title
Yoga
Arm Type
Other
Arm Description
Group of participants who recive Yoga sessions during 12 weeks
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dyspnea degree
Description
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.
Time Frame
Up to 12 weeks
Title
Aerobic capacity
Description
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.
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalia Suarez, Profesional
Organizational Affiliation
Professor CES University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD
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