Cardiorespiratory Performance in Diabetic Elderly

Hypertensive Patients Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757080
• Other study ID #: etiene
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: December 20, 2012
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetics Patients
• Hypertensive Patients

Intervention

Other:
• Cardiorespiratory performance assessment with ergospirometry test

• Biochemical analysis

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Hollenberg M, Yang J, Haight TJ, Tager IB. Longitudinal changes in aerobic capacity: implications for concepts of aging. J Gerontol A Biol Sci Med Sci. 2006 Aug;61(8):851-8. — View Citation

Kathiresan S, Otvos JD, Sullivan LM, Keyes MJ, Schaefer EJ, Wilson PW, D'Agostino RB, Vasan RS, Robins SJ. Increased small low-density lipoprotein particle number: a prominent feature of the metabolic syndrome in the Framingham Heart Study. Circulation. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory exercise test	To analyze the influence of lipid control during a cardiorespiratory exercise test in two subgroups.	six months	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

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