Cardiorespiratory Performance in Diabetic Elderly

December 20, 2012 updated by: Daniella Cunha Brandao, Universidade Federal de Pernambuco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52061-100
        • Universidade Federal de Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory exercise test
Time Frame: six months
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)
Time Frame: 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).
Six months
Assessment of functional capacity was quantitatively analyzed based on the scores obtained in the Instrumental Activities of Daily Living (IADL).
Time Frame: 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.
Six months
Assessment of biochemical determinations
Time Frame: 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).
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 28, 2012

Study Record Updates

Last Update Posted (Estimate)

December 28, 2012

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • etiene

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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