Clinical trial NCT01757080: Cardiorespiratory Performance in Diabetic Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetics Patients
Hypertensive Patients
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2012-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cardiorespiratory exercise test
timeFrame: six months
Secondary outcomes:
measure: Physical activity level assessment performed with the International Physical Activity Questionnaire (IPAQ)
timeFrame: Six months
measure: Assessment of functional capacity was quantitatively analyzed based on the scores obtained in the Instrumental Activities of Daily Living (IADL).
timeFrame: Six months
measure: Assessment of biochemical determinations
timeFrame: Six months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
References:
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. 2006 Jan 3;113(1):20-9. doi: 10.1161/CIRCULATIONAHA.105.567107. Epub 2005 Dec 27.
citation: 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. doi: 10.1093/gerona/61.8.851.