Cardiorespiratory Performance in Diabetic Elderly

Not Applicable

Completed

• Conditions: Diabetics Patients; Hypertensive Patients
• Interventions: Other: Cardiorespiratory performance assessment with ergospirometry test; Other: Biochemical analysis

• Registration Number: NCT01757080
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-06
• Status Verified: 2012-10
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-20
• Last Update Submitted: 2012-12-20
• Study First Posted: 2012-12-28
• Last Update Posted: 2012-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic-hypertensive elderly	Cardiorespiratory performance assessment with ergospirometry test	Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test
Diabetic-hypertensive elderly	Biochemical analysis	Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test
Hypertensive elderly	Cardiorespiratory performance assessment with ergospirometry test	Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test
Hypertensive elderly	Biochemical analysis	Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory exercise test	six months	To analyze the influence of lipid control during a cardiorespiratory exercise test in two subgroups.

Secondary Outcome Measures

Name	Time	Method
Physical activity level assessment performed with the International Physical Activity Questionnaire (IPAQ)	Six months	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).
Assessment of functional capacity was quantitatively analyzed based on the scores obtained in the Instrumental Activities of Daily Living (IADL).	Six months	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.
Assessment of biochemical determinations	Six months	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).

Trial Locations

Locations (1)

Universidade Federal de Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil