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Completed

NCT Number: NCT02778568

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

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

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Hospital of Pernambuco - PROCAPE

Recife, Pernambuco, 50100-060, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

Behavioral

Resistance training exercises

Other names: Physical training

Control

Behavioral

Stretching exercises

Primary outcomes

  1. Change in blood pressure

    Time frame: Change from baseline to 12 and 24 weeks

Secondary outcomes

  1. Change in Walking distance

    Time frame: Change from baseline to 12 and 24 weeks

  2. Change in Health related Quality of life

    Time frame: Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks

  3. 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

  4. Change in body fat

    Time frame: Change from baseline to 12 and 24 weeks

  5. Change Serum Cholesterol

    Time frame: Change from baseline to 12 and 24 weeks

  6. Change in serum glucose

    Time frame: Change from baseline to 12 and 24 weeks

  7. Change in TNFalpha

    Time frame: Change from baseline to 12 and 24 weeks

  8. Change in Score Short-physical performance battery

    Time frame: Change from baseline to 12 and 24 weeks

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Collaborators

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

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
May 20, 2016
Registry last updated
May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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