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

Primary Purpose

Peripheral Artery Disease, Intermittent Claudication

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance training
Control
Sponsored by
University of Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency Hospital of Pernambuco - PROCAPE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resistance Training

Control

Arm Description

Patients performed resistance exercises

Patients who performed flexibility exercise

Outcomes

Primary Outcome Measures

Change in blood pressure

Secondary Outcome Measures

Change in Walking distance
Change in Health related Quality of life
Change in Muscle blood flow of limbs
Muscle blood flow assessed with venous occlusion plethysmography
Change in body fat
Change Serum Cholesterol
Change in serum glucose
Change in TNFalpha
Change in Score Short-physical performance battery

Full Information

First Posted
December 12, 2013
Last Updated
May 23, 2016
Sponsor
University of Pernambuco
Collaborators
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02778568
Brief Title
Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients
Official Title
Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pernambuco
Collaborators
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Intermittent Claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance Training
Arm Type
Experimental
Arm Description
Patients performed resistance exercises
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients who performed flexibility exercise
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Other Intervention Name(s)
Physical training
Intervention Description
Resistance training exercises
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Stretching exercises
Primary Outcome Measure Information:
Title
Change in blood pressure
Time Frame
Change from baseline to 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Change in Walking distance
Time Frame
Change from baseline to 12 and 24 weeks
Title
Change in Health related Quality of life
Time Frame
Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks
Title
Change in Muscle blood flow of limbs
Description
Muscle blood flow assessed with venous occlusion plethysmography
Time Frame
Change from baseline to 12 and 24 weeks
Title
Change in body fat
Time Frame
Change from baseline to 12 and 24 weeks
Title
Change Serum Cholesterol
Time Frame
Change from baseline to 12 and 24 weeks
Title
Change in serum glucose
Time Frame
Change from baseline to 12 and 24 weeks
Title
Change in TNFalpha
Time Frame
Change from baseline to 12 and 24 weeks
Title
Change in Score Short-physical performance battery
Time Frame
Change from baseline to 12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilia A Correia, MS
Organizational Affiliation
University of Pernambuco
Official's Role
Study Chair
Facility Information:
Facility Name
Emergency Hospital of Pernambuco - PROCAPE
City
Recife
State/Province
PE
ZIP/Postal Code
50100-060
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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