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

NCT ID: NCT03272737

Last Updated: 2022-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-04

Study Completion Date

2022-01-04

Brief Summary

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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.

Detailed Description

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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

Conditions

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Frail Elderly Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: Blood flow restriction + low intensity strength exercise Group 2: Low intensity strength exercise
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

1RM Test

Intervention Type PROCEDURE

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).

Speed gait test

Intervention Type PROCEDURE

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).

Venous occlusion plethysmography protocol

Intervention Type DEVICE

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).

Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity

Intervention Type DEVICE

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).

Isometric handgrip exercise protocol

Intervention Type DEVICE

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.

Vasodilatory capacity

Intervention Type DEVICE

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.

Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)

Intervention Type DEVICE

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).

Quality of Life EuroQol-5 Domain

Intervention Type DIAGNOSTIC_TEST

This questionnaire is used to estimate the quality of life in participants before and after the study.

Anthropometric Assessment

Intervention Type OTHER

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.

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

Group Type ACTIVE_COMPARATOR

1RM Test

Intervention Type PROCEDURE

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).

Speed gait test

Intervention Type PROCEDURE

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).

Venous occlusion plethysmography protocol

Intervention Type DEVICE

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).

Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity

Intervention Type DEVICE

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).

Isometric handgrip exercise protocol

Intervention Type DEVICE

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.

Vasodilatory capacity

Intervention Type DEVICE

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.

Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)

Intervention Type DEVICE

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).

Quality of Life EuroQol-5 Domain

Intervention Type DIAGNOSTIC_TEST

This questionnaire is used to estimate the quality of life in participants before and after the study.

Anthropometric Assessment

Intervention Type OTHER

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.

Interventions

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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).

Intervention Type 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).

Intervention Type PROCEDURE

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).

Intervention Type 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).

Intervention Type 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.

Intervention Type 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.

Intervention Type 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).

Intervention Type DEVICE

Quality of Life EuroQol-5 Domain

This questionnaire is used to estimate the quality of life in participants before and after the study.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Other Intervention Names

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1RM Test (Knee extension and Seated leg press)

Eligibility Criteria

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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).
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luciana D Janot, Phd

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

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Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016/07993-3

Identifier Type: -

Identifier Source: org_study_id

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