Frail Elderly Syndrome Clinical Trial
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.
Verified date | March 2020 |
Source | Hospital Israelita Albert Einstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 4, 2022 |
Est. primary completion date | June 4, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP) | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
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* Note: There are 65 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Plesthysmography | Evaluation of muscle blood flow by plethysmography of venous occlusion | Before and after 12 weeks of training | |
Other | Pulse wave velocity | The estimation of the arterial stiffness will be made from the evaluation of the carotid-femoral aortic pulse wave velocity. | Before and after 12 weeks of training | |
Primary | 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 | Coagulation factors | Blood tests (fibrinogen, Factor VIII, von Willebrand Factor, D-dimer, t-PA and PAI 1) | Before and after 12 weeksof training | |
Secondary | Tolerability, adherence and adverse effects | Evaluate the tolerability, adherence and adverse effects of both groups - Questionnaire | Before and after 12 weeks of training | |
Secondary | Arterial pressure and heart rate | Blood pressure and heart rate measurements | Before and after 12 weeks of training | |
Secondary | 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 |
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