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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

26

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

Hospital Israelita Albert Einstein

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • 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)

February 4, 2018

Primary Completion (ACTUAL)

June 4, 2020

Study Completion (ACTUAL)

January 4, 2022

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (ACTUAL)

September 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID 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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