NCT03580538

Brief Summary

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%).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

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

March 5, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
Last Updated

July 9, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

June 14, 2018

Last Update Submit

July 6, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change from baseline Muscular Strength at 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

    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

    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

    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

Study Arms (1)

elastic tube group

EXPERIMENTAL
Other: resistive exercise with elastic tube

Interventions

performed training with elastic tubing for six weeks, twice a week and the load was progressively increased every 15 days.

elastic tube group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

June 14, 2018

First Posted

July 9, 2018

Study Start

March 5, 2016

Primary Completion

June 20, 2016

Study Completion

July 30, 2016

Last Updated

July 9, 2018

Record last verified: 2018-06