Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients

May 23, 2016 updated by: Raphael M. Ritti Dias, University of Pernambuco
The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several studies have shown that strength training can promote important benefits for the cardiovascular system in healthy subjects and patients with chronic diseases. However, the effects of resistance exercise on cardiovascular function in intermittent claudication patients are unclear. In addition, it also do not know the chronic effects on cardiovascular function in these patients.

Study Type

Interventional

Enrollment (Actual)

30

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
    • PE
      • Recife, PE, Brazil, 50100-060
        • Emergency Hospital of Pernambuco - PROCAPE

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

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Had a graded treadmill test that was limited by claudication (2 minutes)
  • Had an ankle brachial index <0.90
  • Had systolic blood pressure ,160 mmHg and/or diastolic blood pressure,105 mmHg
  • Were not performing any regular exercise program
  • Were not using antihypertensive medications affecting the heart rate (e.g., b-blockers and nondihydropyridine calcium channel blockers)
  • Were nonobese
  • Individuals who have not undergone bypass surgery or angioplasty least one year ago

Exclusion Criteria:

  • Had no symptoms related to myocardial ischemia during the treadmill test
  • Amputation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance Training
Patients performed resistance exercises
Behavioral: Resistance training
Resistance training exercises
Other Names:
  • Physical training
Active Comparator: Control
Patients who performed flexibility exercise
Behavioral: Control
Stretching exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in blood pressure
Time Frame: Change from baseline to 12 and 24 weeks
Change from baseline to 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Walking distance
Time Frame: Change from baseline to 12 and 24 weeks
Change from baseline to 12 and 24 weeks
Change in Health related Quality of life
Time Frame: Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks
Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks
Change in Muscle blood flow of limbs
Time Frame: Change from baseline to 12 and 24 weeks
Muscle blood flow assessed with venous occlusion plethysmography
Change from baseline to 12 and 24 weeks
Change in body fat
Time Frame: Change from baseline to 12 and 24 weeks
Change from baseline to 12 and 24 weeks
Change Serum Cholesterol
Time Frame: Change from baseline to 12 and 24 weeks
Change from baseline to 12 and 24 weeks
Change in serum glucose
Time Frame: Change from baseline to 12 and 24 weeks
Change from baseline to 12 and 24 weeks
Change in TNFalpha
Time Frame: Change from baseline to 12 and 24 weeks
Change from baseline to 12 and 24 weeks
Change in Score Short-physical performance battery
Time Frame: Change from baseline to 12 and 24 weeks
Change from baseline to 12 and 24 weeks

Collaborators and Investigators

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

Sponsor

University of Pernambuco

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco

Investigators

  • Study Chair: Marilia A Correia, MS, University of Pernambuco

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, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Estimate)

May 25, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMR2013FCPE MOVED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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