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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02935166
Other study ID # 656656933786
Secondary ID
Status Completed
Phase N/A
First received October 12, 2016
Last updated October 14, 2016
Start date February 2015
Est. completion date January 2016

Study information

Verified date October 2016
Source Fundación Cardiovascular de Colombia
Contact n/a
Is FDA regulated No
Health authority Colombia: Ethics Committee
Study type Interventional

Clinical Trial Summary

Respiratory muscle weakness and fatigue are related to clinical deterioration in patients with Chronic Obstructive Pulmonary Disease (COPD). Respiratory muscle training (RMT) is a key therapeutic strategy in these patients. It is necessary therefore to increase its dissemination on a large scale, improve patient´s adherence and optimize the control of the implementation of training. The aim of this project was to design a RMT device including light and sound incentives, digital registration application and analysis of the training sessions, and studying the effectiveness of a new shortened RMT scheme of high intensity that could provide added value to enhance the implementation of training in patients with COPD. From an operational point of view, researches were organized into three packages of complementary work focused on the design of a new portable dual valve with electronic lighting and auditory incentives components. The conceptualization and design of a software to analyze the performance and individual continuous use of the valve, and the evaluation of the feasibility, safety and efficacy of a shortened schedule of respiratory muscle training in adult patients with COPD were realized.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis from moderate to severe COPD muscle weakness inspiratory Must be able to do exercises

Exclusion Criteria:

- Positive bronchodilator response Cardiovascular, neuromuscular, or metabolic disease Hospital admission for any pathology in the last two months have completed a rehabilitation program in the last year

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Respiratory muscle training
General high-intensity training consists in maximum effort intervals of 30 seconds duration against an equivalent resistance 0.075 kg / kg of body mass followed by a recovery period of 4 minutes cycle ergometer; the total duration was 3 weeks. They were made in this regard, five weekly sessions of 30 minutes per session, Additionally, randomly, the patients were divided into one of 3 possible groups of respiratory training, which consisted of 5 sets of 10 full breaths (inspiration and expiration) in the morning and afternoon during 3 weeks.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Fundación Cardiovascular de Colombia Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Respiratory muscle strength assessed by Maximun Respiratory Pressure Defined as the ability to make a maximum respiratory effort, it was assessed using the MicroRPM® device. This test is to generate the maximum inspiratory pressure (from residual volume) and expiratory (from total lung capacity) against a road or occluded team, performing the maneuver by keeping the mouth and nose occluded. From baseline to 3 weeks No
Primary Change in Exercise Capacity assessed by cardiopulmonary exercise testing From baseline to 3 weeks No
Primary Change in Quality of life assessed by Quality of life Short Form 36 questionnaire From baseline to 3 weeks No
Secondary Change in Exercise Capacity assessed by Six minutes walking Test From baseline to 3 weeks No
Secondary Change in Respiratory function assessed by spirometry From baseline to 3 weeks No
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