Low Intensity Training Combined With KAATSU on Muscle Vasodilatation and Arterial Stiffness in the Elderly Population

February 10, 2022 updated by: Hospital Israelita Albert Einstein

Effect of Low Intensity Strength Training Combined With Moderate Blood Flow Restriction on Muscle Vasodilatation and Arterial Stiffness in Elders With Low Gait Velocity.

The purpose of the present study is to evaluate the acute and chronic effect of low intensity strength training with or without moderate blood flow restriction on muscle vasodilation and arterial stiffness in elders with low gait speed. In addition, the responses of prothrombotic factors in blood coagulation, the impact on heart rate and arterial pressure will be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators propose a study of 26 sedentary elders with low speed gait, supervised by the Hospital Israelita Albert Einstein - Vila Mariana ambulatory. This will be an open clinical trial, prospective, single center, randomized and controlled study. It will be divided into two parts: acute and chronic phases. After signing an informed consent, the participants will be separated in two groups:

Group 1. Resistance exercise with low intensity combined with partial blood flow restriction Group 2. Conventional resistance exercise with low intensity

All of participants will be submitted to interventions tests before and after the period of training which are:

  1. Laboratory Tests: Blood tests
  2. Plethysmography
  3. Handgrip
  4. Quality of life questionaire
  5. FMD tests
  6. Vasodilation capacity

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05652-000
        • Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elderly people aged 60 to 85 years, with walking speed <0.8m / s (Guralnik, 1994).

Exclusion Criteria:

  • Elderly patients with uncontrolled diabetes mellitus or peripheral neuropathy;
  • Symptomatic peripheral obstructive arterial disease or brachial ankle index <0.9;
  • Uncontrolled arterial hypertension (BP> 160 / 100mmHg);
  • Uncontrolled dyslipidemia (total colostrum> 220mg / dL);
  • Infectious with less than 1 month;
  • Osteoarticular or neurological problems that prevent training;
  • History of anemia, cerebrovascular disease, myocardial infarction in the last 6 months;
  • Pior deep venous thrombosis;
  • Use of oral anticoagulant;
  • Smoking <6 months;
  • Use of antiplatelet agents and anticoagulants;
  • Cognitive dysfunctions: Mini-mental <24. (Brucki, 2003).

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Traditional strength exercise

This group will be carried out to knee extension exercise without blood flow restriction.

Interventions:

  • Plethysmography;
  • Protocols of isometric exercise;
  • Pulse wave Velocity (PWV);
  • Flow-mediated dilatation (FMD);
  • Arterial pressure and blood pressure;
  • Quality of life (Euro Qol);
  • 1RM test
  • Speed gait test
  • Anthropometric Assessment
Procedure: 1RM Test
The dynamic force of the lower limb muscles will be evaluated by the maximal repetition of knee extension and leg press exercise, according to the protocol presented in a previous study [37]. The elderly will perform a warm up consisting of 1 series with 10 unloaded repetitions. After the warm up, the mass to be lifted will be progressively increased until the maximum load that can be lifted is reached, with a maximum limit of 5 attempts and a 3 to 5 minutes interval between them. The test will be conducted by a physical education professional who will verbally encourage participants throughout these steps and perform the load adjustment at week 5 and 10 (Radaelli, 2014).
Other Names:
  • 1RM Test (Knee extension and Seated leg press)
Procedure: Speed gait test
To measure the gait speed of participants they will walk 4.6 metres and the time needed to cover this distance is measured. The mean of three attempts is recorded and divided by the distance. The participants included must achieve in the walking test an average of < 0.,9 m/s (Guralnik, 1994).
Device: Venous occlusion plethysmography protocol
A mercury-filled silastic tube, connected to a low-pressure transducer and a plethysmograph (D.E. Hokanson), will be placed around the largest circumference of the calf region. One cuff will be placed around the ankle and another around the thigh. The ankle cuff will be inflated to a supra-systolic pressure 30 seconds before starting the measurements. At 15-second intervals, the cuff around the thigh will be inflated above the venous pressure for a period of seven to eight seconds. Increased tension in the silastic tube reflects an increase in leg volume and vasodilation. The signal of the muscle blood flow wave will be recorded on a polygraph and analysed every minute, averaging three records per minute. The protocol will be performed during 5 minutes of rest, 3 minutes isometric exercise and 2 minutes of recovery (Bahia, 2006).
Device: Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity
Arterial stiffness will be estimated from the carotid-femoral aortic pulse wave velocity [33]. Carotid-femoral aortic pulse waves will be recorded by tonometry (SphygmoCor, AtCor Medical, Australia). At the same time, an electrocardiogram will be obtained to calculate the wave transit time. Two distances will be measured: the recording point of the carotid artery and the sternal furcula (distance 1) and the sternal furcula and the recording point in the femoral artery (distance 2). The distance travelled by the pulse wave will be calculated as "distance 2" - "distance 1". The carotid-femoral aortic pulse wave velocity will be calculated as: carotid-femoral aortic pulse wave velocity = ¼ * distance travelled by the pulse wave (m) / transit time(s).
Device: Isometric handgrip exercise protocol
In a supine position, the maximal voluntary handgrip force will be determined as the highest force in 3 consecutive attempts using a Jamar hydraulic palmar dynamometer (Asimow Engineering, CAL, USA). For activation of the central command, mechanoreceptors and muscular metaboreceptors the individual will perform, after 5 minutes of rest (baseline records), 3 minutes of exercise at 30% MVC. This manoeuvre isolates the activation of muscle metaboreceptors, observing the selective activation of these. After the isometric handgrip exercise, 2 minutes of recovery will be performed. Throughout the protocol muscle blood flow, blood pressure and heart rate will be recorded.
Device: Vasodilatory capacity
The vasodilatory capacity will be calculated as the percentage of increase of the diameter of the brachial artery and femoral post occlusion in relation to its basal values.
Device: Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)
Images of the brachial artery will be recorded by a two-dimensional ultrasonography device with a spectral Doppler and linear transducer (Ultra-0122, Philips, The Netherlands).
Diagnostic test: Quality of Life EuroQol-5 Domain
This questionnaire is used to estimate the quality of life in participants before and after the study.
Other: Anthropometric Assessment
Anthropometric measurements will be made before and after the training program following the standardization of the International Society for Anthropometric Assessments. The body mass will be measured with an accuracy of 0.1 kg (Filizola). The stature will be obtained by means of the stadiometer with an accuracy of 0.5 cm. The BMI will be calculated as body mass divided by height squared. The circumference of the quadriceps will be measured with a tape measure (Seca) with a precision of 0.1 cm.
ACTIVE_COMPARATOR: Strength exercise with KAATSU

This group will be carried out to knee extension exercise with partial blood flow restriction.

Interventions:

  • Plethysmography;
  • Protocols of isometric exercise;
  • Pulse wave Velocity (PWV);
  • Flow-mediated dilatation (FMD);
  • Arterial pressure and blood pressure;
  • Quality of life (Euro Qol);
  • 1RM test
  • Speed gait test
  • Anthropometric Assessment
Procedure: 1RM Test
The dynamic force of the lower limb muscles will be evaluated by the maximal repetition of knee extension and leg press exercise, according to the protocol presented in a previous study [37]. The elderly will perform a warm up consisting of 1 series with 10 unloaded repetitions. After the warm up, the mass to be lifted will be progressively increased until the maximum load that can be lifted is reached, with a maximum limit of 5 attempts and a 3 to 5 minutes interval between them. The test will be conducted by a physical education professional who will verbally encourage participants throughout these steps and perform the load adjustment at week 5 and 10 (Radaelli, 2014).
Other Names:
  • 1RM Test (Knee extension and Seated leg press)
Procedure: Speed gait test
To measure the gait speed of participants they will walk 4.6 metres and the time needed to cover this distance is measured. The mean of three attempts is recorded and divided by the distance. The participants included must achieve in the walking test an average of < 0.,9 m/s (Guralnik, 1994).
Device: Venous occlusion plethysmography protocol
A mercury-filled silastic tube, connected to a low-pressure transducer and a plethysmograph (D.E. Hokanson), will be placed around the largest circumference of the calf region. One cuff will be placed around the ankle and another around the thigh. The ankle cuff will be inflated to a supra-systolic pressure 30 seconds before starting the measurements. At 15-second intervals, the cuff around the thigh will be inflated above the venous pressure for a period of seven to eight seconds. Increased tension in the silastic tube reflects an increase in leg volume and vasodilation. The signal of the muscle blood flow wave will be recorded on a polygraph and analysed every minute, averaging three records per minute. The protocol will be performed during 5 minutes of rest, 3 minutes isometric exercise and 2 minutes of recovery (Bahia, 2006).
Device: Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity
Arterial stiffness will be estimated from the carotid-femoral aortic pulse wave velocity [33]. Carotid-femoral aortic pulse waves will be recorded by tonometry (SphygmoCor, AtCor Medical, Australia). At the same time, an electrocardiogram will be obtained to calculate the wave transit time. Two distances will be measured: the recording point of the carotid artery and the sternal furcula (distance 1) and the sternal furcula and the recording point in the femoral artery (distance 2). The distance travelled by the pulse wave will be calculated as "distance 2" - "distance 1". The carotid-femoral aortic pulse wave velocity will be calculated as: carotid-femoral aortic pulse wave velocity = ¼ * distance travelled by the pulse wave (m) / transit time(s).
Device: Isometric handgrip exercise protocol
In a supine position, the maximal voluntary handgrip force will be determined as the highest force in 3 consecutive attempts using a Jamar hydraulic palmar dynamometer (Asimow Engineering, CAL, USA). For activation of the central command, mechanoreceptors and muscular metaboreceptors the individual will perform, after 5 minutes of rest (baseline records), 3 minutes of exercise at 30% MVC. This manoeuvre isolates the activation of muscle metaboreceptors, observing the selective activation of these. After the isometric handgrip exercise, 2 minutes of recovery will be performed. Throughout the protocol muscle blood flow, blood pressure and heart rate will be recorded.
Device: Vasodilatory capacity
The vasodilatory capacity will be calculated as the percentage of increase of the diameter of the brachial artery and femoral post occlusion in relation to its basal values.
Device: Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)
Images of the brachial artery will be recorded by a two-dimensional ultrasonography device with a spectral Doppler and linear transducer (Ultra-0122, Philips, The Netherlands).
Diagnostic test: Quality of Life EuroQol-5 Domain
This questionnaire is used to estimate the quality of life in participants before and after the study.
Other: Anthropometric Assessment
Anthropometric measurements will be made before and after the training program following the standardization of the International Society for Anthropometric Assessments. The body mass will be measured with an accuracy of 0.1 kg (Filizola). The stature will be obtained by means of the stadiometer with an accuracy of 0.5 cm. The BMI will be calculated as body mass divided by height squared. The circumference of the quadriceps will be measured with a tape measure (Seca) with a precision of 0.1 cm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anthropometric Assessment
Time Frame: Before and after 12 weeksof training
The body weight will be evaluated using the Filizola brand scale, with an accuracy of 0.1 kg. The stature will be obtained by means of the stadiometer coupled to the Filizola scale, with an accuracy of 0.5 cm. The BMI will be calculated from the weight ratio by height squared. For measures of circumference of the quadriceps, a tape measure of the brand Seca, with precision of 0.1 cm will be used. Anthropometric measurements will be made following the standardization of the International Society for Anthropometric Assessments (ISAK, 2001).
Before and after 12 weeksof training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coagulation factors
Time Frame: Before and after 12 weeksof training
Blood tests (fibrinogen, Factor VIII, von Willebrand Factor, D-dimer, t-PA and PAI 1)
Before and after 12 weeksof training
Tolerability, adherence and adverse effects
Time Frame: Before and after 12 weeks of training
Evaluate the tolerability, adherence and adverse effects of both groups - Questionnaire
Before and after 12 weeks of training
Arterial pressure and heart rate
Time Frame: Before and after 12 weeks of training
Blood pressure and heart rate measurements
Before and after 12 weeks of training
Speed Gait
Time Frame: Before and after 12 weeks of training
The gait velocity analysis will be performed with time marking, in thousandths of a second, from the displacement of the elderly in a 4.6-meter straight course, based on the measurement (speed / distance traveled).
Before and after 12 weeks of training

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plesthysmography
Time Frame: Before and after 12 weeks of training
Evaluation of muscle blood flow by plethysmography of venous occlusion
Before and after 12 weeks of training
Pulse wave velocity
Time Frame: Before and after 12 weeks of training
The estimation of the arterial stiffness will be made from the evaluation of the carotid-femoral aortic pulse wave velocity.
Before and after 12 weeks of training

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Israelita Albert Einstein

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luciana D Janot, Phd, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 4, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/07993-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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