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Cardiorespiratory Performance in Diabetic Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniella Cunha Brandao, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01757080
First received: December 4, 2012
Last updated: December 20, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetics Patients
Hypertensive Patients
 Other: Cardiorespiratory performance assessment with ergospirometry test
Other: Biochemical analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • Cardiorespiratory exercise test [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    To analyze the influence of lipid control during a cardiorespiratory exercise test in two subgroups.


Secondary Outcome Measures:
  • Physical activity level assessment performed with the International Physical Activity Questionnaire (IPAQ) [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    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). [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 40
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetic-hypertensive elderly
Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test
 Other: Cardiorespiratory performance assessment with ergospirometry test Other: Biochemical analysis
Active Comparator: Hypertensive elderly
Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test
 Other: Cardiorespiratory performance assessment with ergospirometry test Other: Biochemical analysis

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757080

Locations
Brazil
Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil, 52061-100
Sponsors and Collaborators
Universidade Federal de Pernambuco
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Daniella Cunha Brandao, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01757080     History of Changes
Other Study ID Numbers: etiene
Study First Received: December 4, 2012
Last Updated: December 20, 2012
Health Authority: Brazil: Ethics Committee

ClinicalTrials.gov processed this record on May 23, 2013