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

Study Overview
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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: Laboratory Tests: Blood tests Plethysmography Handgrip Quality of life questionaire FMD tests Vasodilation capacity

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

Conditions
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Frail Elderly Syndrome

Intervention / Treatment
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* Procedure: 1RM Test
* Procedure: Speed gait test
* Device: Venous occlusion plethysmography protocol
* Device: Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity
* Device: Isometric handgrip exercise protocol
* Device: Vasodilatory capacity
* Device: Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)
* Diagnostic Test: Quality of Life EuroQol-5 Domain
* Other: Anthropometric Assessment


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Blood flow restriction + low intensity strength exercise Group 2: Low intensity strength exercise
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional strength exercise<br>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<br>* 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).<br>* Other names: 1RM Test (Knee extension and Seated leg press);Procedure: Speed gait test<br>* 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).<br>Device: Venous occlusion plethysmography protocol<br>* 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).<br>Device: Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity<br>* 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).<br>Device: Isometric handgrip exercise protocol<br>* 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.<br>Device: Vasodilatory capacity<br>* 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.<br>Device: Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)<br>* 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).<br>Diagnostic Test: Quality of Life EuroQol-5 Domain<br>* This questionnaire is used to estimate the quality of life in participants before and after the study.<br>Other: Anthropometric Assessment<br>* 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.<br>|
| Active Comparator: Strength exercise with KAATSU<br>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<br>* 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).<br>* Other names: 1RM Test (Knee extension and Seated leg press);Procedure: Speed gait test<br>* 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).<br>Device: Venous occlusion plethysmography protocol<br>* 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).<br>Device: Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity<br>* 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).<br>Device: Isometric handgrip exercise protocol<br>* 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.<br>Device: Vasodilatory capacity<br>* 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.<br>Device: Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)<br>* 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).<br>Diagnostic Test: Quality of Life EuroQol-5 Domain<br>* This questionnaire is used to estimate the quality of life in participants before and after the study.<br>Other: Anthropometric Assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric Assessment | 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 | 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 | Evaluate the tolerability, adherence and adverse effects of both groups - Questionnaire | Before and after 12 weeks of training | 
| Arterial pressure and heart rate | Blood pressure and heart rate measurements | Before and after 12 weeks of training | 
| Speed Gait | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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KAATSU, Cardiovascular system, Elderly