Clinical trial NCT03272737: Low Intensity Training Combined With KAATSU on Muscle Vasodilatation and Arterial Stiffness in the Elderly Population
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: KAATSU
Cardiovascular system
Elderly
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-09-06
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Blood flow restriction + low intensity strength exercise Group 2: Low intensity strength exercise
Primary purpose: TREATMENT

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

Eligibility criteria: 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).

Primary outcomes:
measure: Anthropometric Assessment
timeFrame: Before and after 12 weeksof training
Secondary outcomes:
measure: Coagulation factors
timeFrame: Before and after 12 weeksof training
measure: Tolerability, adherence and adverse effects
timeFrame: Before and after 12 weeks of training
measure: Arterial pressure and heart rate
timeFrame: Before and after 12 weeks of training
measure: Speed Gait
timeFrame: Before and after 12 weeks of training
Other outcomes:
measure: Plesthysmography
timeFrame: Before and after 12 weeks of training
measure: Pulse wave velocity
timeFrame: Before and after 12 weeks of training
Locations:
city: São Paulo
country: Brazil
facility: Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
state: SP
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Luciana D Janot, Phd
role: PRINCIPAL_INVESTIGATOR
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