Cardiorespiratory Performance in Diabetic Elderly

Study Overview
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Brief Summary
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OBJECTIVE: To analyze the influence of lipid control during a cardiorespiratory exercise test in two subgroups. DESIGN: Parallel trial study. PARTICIPANTS: The sample consisted of 40 elderly people, male and female, divided into two groups: 20 hypertensive (G1; 68.50 ±5.85 years) and 20 diabetic-hypertensive (G2; 68.95 ±6.79 years). MEASUREMENTS: Nutritional status; glucose and lipid controls - postprandial glucose (PPG), triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL-C), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C); blood pressure, and cardiorespiratory performance. The significance level was set at p<0.05.

Conditions
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Diabetics Patients, Hypertensive Patients

Intervention / Treatment
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* Other: Cardiorespiratory performance assessment with ergospirometry test
* Other: Biochemical analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60-years-old or above diagnosis of hypertension and/or T2DM for at least 2 years member active of the hypertension and diabetes mellitus program be on optimized drug therapy for more than 3 months BMI above 22 kg/m²; no heart disease non-insulin-dependent, sedentary according to the International Physical Activity Questionnaire (IPAQ) and functionally independent. Exclusion Criteria: ergospirometry interrupted by adaptive, hemodynamic, and electrocardiographic complications; respiratory exchange ratio (R) lower than 1.0 at the end of exertion, VE/VCO2 value higher than 34 in the first anaerobic threshold; chronic atrial fibrillation; neuromuscular, orthopedic, peripheral vascular, pulmonary diseases; myocardial infarction within 6 months; orthopedic limitation or musculoskeletal pain.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetic-hypertensive elderly<br>Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test | Other: Cardiorespiratory performance assessment with ergospirometry test<br> <br> Other: Biochemical analysis<br> <br> |
| Active Comparator: Hypertensive elderly<br>Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test | Other: Cardiorespiratory performance assessment with ergospirometry test<br> <br> Other: Biochemical analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory exercise test | To analyze the influence of lipid control during a cardiorespiratory exercise test in two subgroups. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity level assessment performed with the International Physical Activity Questionnaire (IPAQ) | This questionnaire was validated in a Brazilian population and in an interview approach. It contains questions regarding frequency and duration of physical activities, classifying the elderly in four categories: very active, active, irregularly active, and sedentary. The physical activity level was investigated considering two variables: Sedentariness and Time of moderate intensity activities (TMIA). The presence of sedentariness was established in those subjects who were classified as sedentary and all other classifications were grouped as absence of sedentariness. The TMIA referred to the time self-reported by the subjects, weekly, in minutes spent in performing moderate intensity activities , calculated according to the answers to questions 2a and 2b from IPAQ, as follows: TMIA = (n days) x (time in min). | Six months | 
| Assessment of functional capacity was quantitatively analyzed based on the scores obtained in the Instrumental Activities of Daily Living (IADL). | This scale has as maximum score 27 points, with the following classification: (27-26 points), partially dependent (25-10 points) and dependent (<10 points). The presence of functional decline was seen in those patients who had complete or partial dependence on IADL. | Six months | 
| Assessment of biochemical determinations | Venous blood samples were drawn from an antecubital vein early in the morning in a fasting state and assessed by a biochemical laboratory. The measured parameters included: Fasting plasma glucose (FPG), lipid profile (serum triglycerides _ TG, serum total cholesterol _ TC, serum low density lipoprotein cholesterol _ LDL-C, serum high density lipoprotein cholesterol _ HDL-C). Serum biochemistries were performed by automated enzimatic method, under routine laboratory procedures. The LDL-C was calculated using the Friedewald formula [22]. The normal values for parameters FPG, TG, TC, LDL-C, HDL-C used in this research were defined by the revised National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III). | Six months |