- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837639
Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease
Effects of Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease: a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raphael M Ritti-Dias, PhD
- Phone Number: +551999406878
- Email: raphaelritti@gmail.com
Study Contact Backup
- Name: Marilia A Correia, PhD
- Phone Number: +5511999711669
- Email: marilia.correia@live.com
Study Locations
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-
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São Paulo, Brazil, 05652-900
- Recruiting
- Hospital Israelita Albert Einstein
-
Contact:
- Gabriel Cucato, PhD
- Phone Number: +5511967318023
- Email: gabriel.grizzo@einstein.br
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Principal Investigator:
- Gabriel Cucato, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Change from baseline in ambulatory blood pressure at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Change from baseline in ambulatory blood pressure at 12 weeks
|
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).
|
Change from baseline in ambulatory blood pressure at 12 weeks
|
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).
|
Change from baseline in ambulatory blood pressure at 12 weeks
|
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).
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Change from baseline in arterial stiffness at 12 weeks
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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).
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Change from baseline in flow-mediated vasodilation at 12 weeks
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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
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Change from baseline in walking distance at 12 weeks
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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
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Change from baseline in the number of the steps at 12 weeks
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Subjective measurement of walking capacity
Time Frame: Change from baseline in the walking impairment questionnaire score after 12 weeks
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Walking impairment questionnaire will be measured before and after 12 weeks of intervention
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Change from baseline in the walking impairment questionnaire score after 12 weeks
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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
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Change from baseline in the Walking estimated limitation calculated by history questionnaire score after 12 weeks
|
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
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Change from baseline in kgf of the handgrip test after 12 weeks
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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.
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Change from baseline in the Baltimore Activity Scale for Intermittent Claudication score after 12 weeks
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General functional capacity
Time Frame: Change from baseline in the Short Physical Performance Battery score after 12 weeks
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The Short Physical Performance Battery will be measured before and after 12 weeks of intervention.
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Change from baseline in the Short Physical Performance Battery score after 12 weeks
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Specific quality of life of vascular patients
Time Frame: Change from baseline in the Vascular quality of life questionnaire score after 12 weeks
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The Vascular quality of life questionnaire will be measured before and after 12 weeks of intervention.
|
Change from baseline in the Vascular quality of life questionnaire score after 12 weeks
|
General quality of life
Time Frame: Change from baseline in the World Health Organization Quality of Life score after 12 weeks
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The World Health Organization Quality of Life questionnaire will be measured before and after 12 weeks of intervention
|
Change from baseline in the World Health Organization Quality of Life score after 12 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Hélcio Kanegusuku, PhD, Israelite Institute for Education and Research
Publications and helpful links
General 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.
- 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(8):CD009638. doi: 10.1002/14651858.CD009638.pub3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAD01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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