Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease

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ClinicalTrials.gov Identifier: NCT03837639

Recruitment Status : Suspended (The study was suspended indefinitely because of Covid-19.)

First Posted : February 12, 2019

Last Update Posted : March 31, 2020

Sponsor:

Collaborators:

University of Nove de Julho

Northumbria University

Information provided by (Responsible Party):

Hospital Israelita Albert Einstein

Study Description

Brief Summary:

The aim of the study is to analyze the effect of 12 weeks of arm crank exercise (ACE) training on cardiovascular function in PAD patients, and compare it with treadmill exercise (TE), the actual recommendation for this patients. In this clinical trial, 45 patients will be allocated randomly in three experimental groups: ACE training, TE and control group. ACE and TE groups will perform exercises twice a week with the intensity equivalent to 13- 15 on Borg's Subjective Perception Exertion Scale. Patients in control group will meet twice a week, however only to perform diverse activities and group living, without any type of exercise involved. All groups will be encouraged to increase their levels of activity, as they are usually guided in medical consultations. Before and after 12 weeks of intervention, cardiovascular function, functional capacity, cognition, and quality of life will be assessed.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease Intermittent Claudication Hypertension	Other: Arm ergometer Other: Treadmill ergometer Other: Control group	Not Applicable

Detailed Description:

Arm-crank exercise (ACT) is an alternative exercise strategy for patients with symptomatic peripheral artery disease (PAD) due the benefits on functional capacity and quality of life, besides provoking less or no pain symptoms during the execution. This study sought to describe the protocol of a study that will analyse the effect of ACT exercise on walking capacity, cardiovascular function, cognition and quality of life in patients with symptomatic PAD.

This is a three-armed randomized, prospective, single-blind data collection, single-center, controlled study enrolling 45 patients with symptomatic PAD which will be randomized into 3 intervention groups: walking training (WT), ACT (WT and AC: 15 to 10 sets of 2 to 5 minutes, Borg 13 to 15) and control group (CG). Before and after 12 weeks of intervention, cardiovascular function (ambulatory blood pressure , clinic blood pressure, central blood pressure, heart rate variability, arterial stiffness, vascular function), functional capacity (six-minute walking test, 2 minute step test [2 MST], Walking impairment questionnaire [WIQ], Walking estimated limitation calculated by history [WELCH], Baltimore activity scale for intermittent claudication, handgrip test and short physical performance battery [SPPB]), cognition (executive function and memory) and quality of life (short version of world health organization quality of life and vascular quality of life questionnaire [VASCUQOL-6]) will be assessed.

This is the first trial to evaluate the effects of ACT on regulatory mechanisms of cardiovascular system in PAD patients. If the results are as expected, they will provide evidence of ACT in promoting cardiovascular benefits in symptomatic PAD population.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effects of Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease: a Randomized Controlled Trial
Actual Study Start Date :	June 10, 2019
Estimated Primary Completion Date :	December 10, 2021
Estimated Study Completion Date :	December 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension

MedlinePlus related topics: Exercise and Physical Fitness Peripheral Arterial Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm crank ergometer Arm-crank exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.	Other: Arm ergometer Arm-crank exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard
Experimental: Treadmill ergometer Walking exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.	Other: Treadmill ergometer Walking exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.
Control group Patients randomized to control group will attend to meetings with the researcher team twice a week during the 12 weeks. At these meetings, patients will perform manual tasks, with or without the use of artistic materials, cultural programs, cooking classes and home care, without any exercise component. This CG practice will be performed in order to minimize the effects of the patient's bi- weekly commitment and displacement to the training site, to minimize the influence of the patient- researcher contact and also minimize the convivial effect among the patients themselves, which will occur in the other two groups.	Other: Control group Patients randomized to control group will attend to meetings with the researcher team twice a week during the 12 weeks. At these meetings, patients will perform manual tasks, with or without the use of artistic materials, cultural programs, cooking classes and home care, without any exercise component. This CG practice will be performed in order to minimize the effects of the patient's bi- weekly commitment and displacement to the training site, to minimize the influence of the patient- researcher contact and also minimize the convivial effect among the patients themselves, which will occur in the other two groups.

Outcome Measures

Primary Outcome Measures :

ambulatory blood pressure [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
Systolic, diastolic and mean blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic ambulatory blood pressure monitor (Cardios, São Paulo, Brazil).

Secondary Outcome Measures :

Clinic blood pressure [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
Systolic and diastolic brachial blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
Central blood pressure [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
Systolic and diastolic central blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
Heart rate variability [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
Heart rate variability will be measured before and after 12 weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA).
Arterial stiffness [ Time Frame: Change from baseline in arterial stiffness at 12 weeks ]
Carotid femoral pulse wave velocity will be measured before and after 12 weeks of intervention period on intervention and control group by pulse wave velocity measurement with applanation tonometry (SphygmoCor, AtCor Medical, Australia).
Vascular function [ Time Frame: Change from baseline in flow-mediated vasodilation at 12 weeks ]
Flow-meadiated dilation will be measured before and after 12 weeks of intervention period on intervention and control group by a flow mediated dilation measurement with an ultrasound image (HDI 5000 Sono CT, Philips, The Netherlands).
Walking capacity [ Time Frame: Change from baseline in walking distance at 12 weeks ]
Six-minute walking test will be measured before and after 12 weeks of intervention
March in place [ Time Frame: Change from baseline in the number of the steps at 12 weeks ]
Two-minute step test will be measured before and after 12 weeks of intervention
Subjective measurement of walking capacity [ Time Frame: Change from baseline in the walking impairment questionnaire score after 12 weeks ]
Walking impairment questionnaire will be measured before and after 12 weeks of intervention
Subjective measurement of walking capacity compared to healthy subjects [ Time Frame: Change from baseline in the Walking estimated limitation calculated by history questionnaire score after 12 weeks ]
Walking estimated limitation calculated by history questionnaire will be measured before and after 12 weeks of intervention
Overall strength test [ Time Frame: Change from baseline in kgf of the handgrip test after 12 weeks ]
Handgrip strength test will be measured before and after 12 weeks of intervention
Symptoms of intermittent claudication [ Time Frame: Change from baseline in the Baltimore Activity Scale for Intermittent Claudication score after 12 weeks ]
The Baltimore Activity Scale for Intermittent Claudication is a questionnaire that will be measured before and after 12 weeks of intervention.
General functional capacity [ Time Frame: Change from baseline in the Short Physical Performance Battery score after 12 weeks ]
The Short Physical Performance Battery will be measured before and after 12 weeks of intervention.
Specific quality of life of vascular patients [ Time Frame: Change from baseline in the Vascular quality of life questionnaire score after 12 weeks ]
The Vascular quality of life questionnaire will be measured before and after 12 weeks of intervention.
General quality of life [ Time Frame: Change from baseline in the World Health Organization Quality of Life score after 12 weeks ]
The World Health Organization Quality of Life questionnaire will be measured before and after 12 weeks of intervention

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	45 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

PAD stage II
Ankle brachial index <0.90 in one or both lower limbs;
Women in post-menopause phase without hormone replacement therapy
Not an active smoker;
Able to perform exercise training;

Patients selected to participate in the study will be only excluded if:

Change their medication;
Present any health impairment that contraindicates the practice of physical exercise during the study;

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837639

Locations

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Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil, 05652-900

Sponsors and Collaborators

Hospital Israelita Albert Einstein

University of Nove de Julho

Northumbria University

More Information

Publications:

Cavalcante BR, Ritti-Dias RM, Soares AH, Lima AH, Correia MA, De Matos LD, Gobbi F, Leicht AS, Wolosker N, Cucato GG. A Single Bout of Arm-crank Exercise Promotes Positive Emotions and Post-Exercise Hypotension in Patients with Symptomatic Peripheral Artery Disease. Eur J Vasc Endovasc Surg. 2017 Feb;53(2):223-228. doi: 10.1016/j.ejvs.2016.11.021. Epub 2016 Dec 21.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jansen SC, Abaraogu UO, Lauret GJ, Fakhry F, Fokkenrood HJ, Teijink JA. Modes of exercise training for intermittent claudication. Cochrane Database Syst Rev. 2020 Aug 20;8:CD009638. doi: 10.1002/14651858.CD009638.pub3.

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Responsible Party:	Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:	NCT03837639
Other Study ID Numbers:	PAD01
First Posted:	February 12, 2019 Key Record Dates
Last Update Posted:	March 31, 2020
Last Verified:	June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	We are planing to share our data in the future.
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Time Frame:	After publication of the main paper.
Access Criteria:	Ask to authors permision.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Hospital Israelita Albert Einstein:


arm-crank exercise training cardiovascular function

Additional relevant MeSH terms:

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Peripheral Arterial Disease Peripheral Vascular Diseases Intermittent Claudication Vascular Diseases	Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases

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