NCT01452932

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_1 chronic-obstructive-pulmonary-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

2.5 years

First QC Date

October 13, 2011

Last Update Submit

June 22, 2012

Conditions

Keywords

Chronic obstructive pulmonary diseaseDyspneaExercise testEndurance training

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 12 weeks

  • 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.

    Up to 12 weeks

Study Arms (2)

Physiotherapy

EXPERIMENTAL

Group of participants who recive physiotherapy treatment using Kabat technique for the upper limbs resistance training during 12 weeks

Other: Physiotherapy

Yoga

OTHER

Group of participants who recive Yoga sessions during 12 weeks

Other: Yoga

Interventions

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.

Physiotherapy
YogaOTHER

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.

Yoga

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Interventions

Physical Therapy ModalitiesYoga

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationMind-Body TherapiesComplementary TherapiesSpiritual TherapiesExercise Movement Techniques

Study Officials

  • Nathalia Suarez, Profesional

    Professor CES University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 17, 2011

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 26, 2012

Record last verified: 2012-06