NCT01757080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 28, 2012

Completed
Last Updated

December 28, 2012

Status Verified

October 1, 2012

Enrollment Period

Same day

First QC Date

December 4, 2012

Last Update Submit

December 20, 2012

Conditions

Diabetics PatientsHypertensive Patients

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory exercise test

    To analyze the influence of lipid control during a cardiorespiratory exercise test in two subgroups.

    six months

Secondary Outcomes (3)

  • Physical activity level assessment performed with the International Physical Activity Questionnaire (IPAQ)

    Six months

  • Assessment of functional capacity was quantitatively analyzed based on the scores obtained in the Instrumental Activities of Daily Living (IADL).

    Six months

  • Assessment of biochemical determinations

    Six months

Study Arms (2)

Diabetic-hypertensive elderly

EXPERIMENTAL

Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test

Other: Cardiorespiratory performance assessment with ergospirometry testOther: Biochemical analysis

Hypertensive elderly

ACTIVE COMPARATOR

Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test

Other: Cardiorespiratory performance assessment with ergospirometry testOther: Biochemical analysis

Interventions

Cardiorespiratory performance assessment with ergospirometry testOTHER
Diabetic-hypertensive elderlyHypertensive elderly
Biochemical analysisOTHER
Diabetic-hypertensive elderlyHypertensive elderly

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 52061-100, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 16380547RESULT

  • 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.

    PMID: 16912104RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 4, 2012

First Posted

December 28, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

December 28, 2012

Record last verified: 2012-10

Locations

BR(1)