- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580538
Training With Elastic Tubing in Cardiopaths: Clinical Trial
The Short-term Effects of a Resistive Training Program Using Elastic Tubing in Cardiac Patients: Clinical Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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