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

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778568
• Other study ID #: RMR2013FCPE MOVED
• Status: Completed
• Phase: N/A
• First received: December 12, 2013
• Last updated: May 23, 2016
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University of Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Behavioral:
• Resistance training
Resistance training exercises
• Control
Stretching exercises

Locations

Country	Name	City	State
Brazil	Emergency Hospital of Pernambuco - PROCAPE	Recife	PE

Sponsors (3)

Lead Sponsor	Collaborator
University of Pernambuco	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure		Change from baseline to 12 and 24 weeks	No
Secondary	Change in Walking distance		Change from baseline to 12 and 24 weeks	No
Secondary	Change in Health related Quality of life		Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks	No
Secondary	Change in Muscle blood flow of limbs	Muscle blood flow assessed with venous occlusion plethysmography	Change from baseline to 12 and 24 weeks	No
Secondary	Change in body fat		Change from baseline to 12 and 24 weeks	No
Secondary	Change Serum Cholesterol		Change from baseline to 12 and 24 weeks	No
Secondary	Change in serum glucose		Change from baseline to 12 and 24 weeks	No
Secondary	Change in TNFalpha		Change from baseline to 12 and 24 weeks	No
Secondary	Change in Score Short-physical performance battery		Change from baseline to 12 and 24 weeks	No