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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
CES University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 13, 2011
    Last Updated
    June 22, 2012
    Sponsor
    CES University
    Collaborators
    La ceja Hospital
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    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

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

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