Training With Elastic Tubing in Cardiopaths: Clinical Trial

July 6, 2018 updated by: Mayara Moura Alves da Cruz, Universidade Estadual Paulista Júlio de Mesquita Filho

The Short-term Effects of a Resistive Training Program Using Elastic Tubing in Cardiac Patients: Clinical Trial

Background: Resistance training is effective in cardiac rehabilitation; however, other types of training, such as elastic tubing, are rarely used and may present good therapeutic alternatives. Due to its practicality and cost effectiveness, training using elastic tubing may become an important tool in cardiovascular rehabilitation. Objective: To evaluate muscular strength, functional capacity, aerobic capacity and quality of life in patients with cardiovascular diseases in phase II of rehabilitation, after resistance training with elastic tubing. Methods: patients with cardiovascular diseases performed training with elastic tubing for six weeks, twice a week and the load was progressively increased every 15 days. The following muscle groups were evaluated and trained: shoulder abductors and flexors, elbow flexors, and knee flexors and extensors. Muscular strength was evaluated using a dynamometer; functional capacity with a 6-minute walk test and ergospirometric test; and quality of life using the SF-36 questionnaire. Data normality was assessed using the Shapiro Wilk test. Comparisons before and after training were performed using the paired Student's t test or the Wilcoxon test (p <5%).

Study Overview

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes
  • Aged between 45-79 years
  • Clinical diagnosis of heart disease (coronary artery disease, postoperative myocardial revascularization, acute myocardial infarction)
  • In phase II of CRP for at least three months

Exclusion Criteria:

  • Patients hemodynamically unstable
  • Patients with changes in medication for a minimum of 30 days
  • Patients who presented arteriopathies, neurological, muscular or orthopedic disorders, such as rheumatism and unstable heart disease that could be detected by electrocardiogram, and lung diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: elastic tube group
performed training with elastic tubing for six weeks, twice a week and the load was progressively increased every 15 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Muscular Strength at 6 weeks
Time Frame: The evaluation of muscular strength was performed at the start of the intervention protocol and after 6 weeks.
The evaluation of muscular strength was performed at the start of the intervention protocol and after 6 weeks, using a digital force gauge, brand Force Gauge®, model FG-100kg - United States, and all results were expressed in Newtons (N). The evaluation was performed with the dominant member of each patient, using a steel cord coated with rigid plastic attached to a dynamometer, with one end attached to a fixed bar and the other end to the distal portion of the dominant member of the patient
The evaluation of muscular strength was performed at the start of the intervention protocol and after 6 weeks.
Change from baseline Functional Capacity at 6 weeks
Time Frame: was performed at the start of the intervention protocol and after 6 weeks
The evaluation of functional capacity was carried out through the 6-minute walk test (6MWT). The 6MWT followed the criteria established by the American Thoracic Society15. The test was performed in a gym hall at Oeste Paulista University, Presidente Prudente/SP-Brazil, and was repeated twice with an interval of 30 minutes between attempts and the highest value was taken into account, during the test Standardized verbal performance incentives were given every minute. During the 6MWT was measured blood pressure, oximetry, perception subjective of effort, heart and respiratory rate.
was performed at the start of the intervention protocol and after 6 weeks
Change from baseline Evaluation of maximal aerobic capacity at 6 weeks
Time Frame: was performed at the start of the intervention protocol and after 6 weeks

The patients underwent a cardiopulmonary test performed by a cardiologist. All tests were performed on a treadmill (Inbrasport ATL 2000). The modified Bruce protocol16 was used and the test performed until voluntary exhaustion. No patient presented alterations in the electrocardiogram that prevented the realization and completion of the test.

Cardiovascular parameters were monitored continuously: heart rate through the Polar S810i, Finland, arterial oxygen saturation using the Mindray PM 50 pulse oximeter, Brazil, and the subjective perception of effort.17 The ventilatory variables were obtained through the VO2000 gas analyzer (Medical Graphics, USA) calibrated before each test according to the manufacturer's instructions. The average air flow was used in all tests and obtained every 10 seconds, Aerograph®, Michigan, USA.

was performed at the start of the intervention protocol and after 6 weeks
Change from baseline Evaluation of quality of life at 6 weeks
Time Frame: was performed at the start of the intervention protocol and after 6 weeks
The quality of life of these patients was assessed using the generic quality of life evaluation questionnaire SF-36, validated in Brazil, which has eight dimensions that are scored from 0 to 100. For each dimension, values greater than 50 are positive in relation to a good perception of quality of life
was performed at the start of the intervention protocol and after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2016

Primary Completion (Actual)

June 20, 2016

Study Completion (Actual)

July 30, 2016

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 44443915.5.0000.5515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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