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

Not Applicable

Completed

• Conditions: Frail Elderly Syndrome
• Interventions: 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

• Registration Number: NCT03272737
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-06
• Study Start: 2018-02-04
• Status Verified: 2020-03
• Primary Completion: 2020-06-04
• Study Completion: 2022-01-04
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional strength exercise	Vasodilatory capacity	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
Traditional strength exercise	1RM Test	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
Traditional strength exercise	Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)	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
Traditional strength exercise	Venous occlusion plethysmography protocol	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
Strength exercise with KAATSU	Isometric handgrip exercise protocol	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
Traditional strength exercise	Speed gait test	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
Traditional strength exercise	Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity	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
Strength exercise with KAATSU	Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)	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
Strength exercise with KAATSU	Anthropometric Assessment	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
Traditional strength exercise	Isometric handgrip exercise protocol	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
Traditional strength exercise	Quality of Life EuroQol-5 Domain	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
Traditional strength exercise	Anthropometric Assessment	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
Strength exercise with KAATSU	Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity	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
Strength exercise with KAATSU	Vasodilatory capacity	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
Strength exercise with KAATSU	1RM Test	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
Strength exercise with KAATSU	Speed gait test	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
Strength exercise with KAATSU	Venous occlusion plethysmography protocol	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
Strength exercise with KAATSU	Quality of Life EuroQol-5 Domain	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

Primary Outcome Measures

Name	Time	Method
Anthropometric Assessment	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).

Secondary Outcome Measures

Name	Time	Method
Tolerability, adherence and adverse effects	Before and after 12 weeks of training	Evaluate the tolerability, adherence and adverse effects of both groups - Questionnaire
Arterial pressure and heart rate	Before and after 12 weeks of training	Blood pressure and heart rate measurements
Coagulation factors	Before and after 12 weeksof training	Blood tests (fibrinogen, Factor VIII, von Willebrand Factor, D-dimer, t-PA and PAI 1)
Speed Gait	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).

Trial Locations

Locations (1)

Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP); 🇧🇷 São Paulo, SP, Brazil