Resistance TrainingNCT03580538
Training With Elastic Tubing in Cardiopaths: Clinical Trial
A study testing resistive exercise with elastic tube in people with Resistance Training and Muscular Strength, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistance Training, Muscular Strength, Cardiovascular Diseases
- What is being tested?
- resistive exercise with elastic tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2016to 30 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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%).
- Being tested
- resistive exercise with elastic tube
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistive exercise with elastic tubeOther
performed training with elastic tubing for six weeks, twice a week and the load was progressively increased every 15 days.
| Study group | Role | What they receive |
|---|---|---|
| elastic tube group | Experimental | Not described Receives: Other: resistive exercise with elastic tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: was performed at the start of the intervention protocol and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start5 Mar 2016
- Primary completion20 Jun 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayara Moura Alves da Cruz, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580538
- Sponsor's protocol ID
- 44443915.5.0000.5515
- Status last verified
- Jun 2018
- First submitted
- 14 Jun 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Effects of a Resistive Training Program Using Elastic Tubing in Cardiac Patients: Clinical Trial
- ClinicalTrials.gov ID
- NCT03580538
- Acronym / sponsor ID
- 44443915.5.0000.5515
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 5 Mar 2016 (actual)
- Primary completion
- 20 Jun 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elastic tube group | Experimental | Other: resistive exercise with elastic tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resistive exercise with elastic tubeperformed training with elastic tubing for six weeks, twice a week and the load was progressively increased every 15 days. | Other | elastic tube group |
Primary outcome
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
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Resistance Training
Not yet recruiting
Contribution of Corticospinal and Reticulospinal Mechanisms to Neural Adaptations Induced by Muscle Strengthening of Healthy Adults
Healthy Volunteers, Resistance Training Adaptation
Active, not recruiting
Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women
Overweight or Obesity, Prediabetes or Diabetes
Not yet recruiting
Effects of Resistance Training on Recovery During Hematopoietic Stem Cell Transplantation
Hematologic Malignancies, Hematopoietic Stem Cell Transplantation
Not yet recruiting
Does Estrogen Blunt the Effects of Exercise Training on Glycemic Control
To Determine Whether Estrogen Influences the Effects of Training on Glycemic Control and Insulin Sensitivity
Recruiting
Skeletal Muscle Adaptations to Peptide-Supplemented Resistance Exercise Training
Supplement, Resistance Training Adaptation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing resistive exercise with elastic tube in people with Resistance Training and Muscular Strength, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.