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

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 60 to 85 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: 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

Frail Elderly Syndrome

Being tested

1RM Test, Speed gait test, Venous occlusion plethysmography protocol, Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity, Isometric handgrip exercise protocol

Keywords

KAATSU, Cardiovascular system, Elderly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 1RM TestProcedure or surgery

  Also called 1RM Test (Knee extension and Seated leg press)

  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 testProcedure or surgery

  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 protocolDevice

  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 VelocityDevice

  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 protocolDevice

  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 capacityDevice

  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)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 DomainDiagnostic test

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

• Anthropometric AssessmentOther

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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).

   Measured: Before and after 12 weeksof training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Sep 2017
2. Study start4 Feb 2018
3. Primary completion4 Jun 2020
4. Study completion4 Jan 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (66)Papers the sponsor has linked to this study.
• Other trials for Frail Elderly SyndromeStudies 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.