- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01452932
Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Nathalia Suarez, Profesional, Professor CES University
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCESCOPD
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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