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

Primary Purpose

Peripheral Arterial Disease, Intermittent Claudication, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Arm ergometer
Treadmill ergometer
Control group
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring arm-crank, exercise training, cardiovascular function

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Hospital Israelita Albert EinsteinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Arm crank ergometer

Treadmill ergometer

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

ambulatory blood pressure
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
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
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
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
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
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
Six-minute walking test will be measured before and after 12 weeks of intervention
March in place
Two-minute step test will be measured before and after 12 weeks of intervention
Subjective measurement of walking capacity
Walking impairment questionnaire will be measured before and after 12 weeks of intervention
Subjective measurement of walking capacity compared to healthy subjects
Walking estimated limitation calculated by history questionnaire will be measured before and after 12 weeks of intervention
Overall strength test
Handgrip strength test will be measured before and after 12 weeks of intervention
Symptoms of intermittent claudication
The Baltimore Activity Scale for Intermittent Claudication is a questionnaire that will be measured before and after 12 weeks of intervention.
General functional capacity
The Short Physical Performance Battery will be measured before and after 12 weeks of intervention.
Specific quality of life of vascular patients
The Vascular quality of life questionnaire will be measured before and after 12 weeks of intervention.
General quality of life
The World Health Organization Quality of Life questionnaire will be measured before and after 12 weeks of intervention

Full Information

First Posted
February 7, 2019
Last Updated
December 6, 2021
Sponsor
Hospital Israelita Albert Einstein
Collaborators
University of Nove de Julho, Northumbria University
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1. Study Identification

Unique Protocol Identification Number
NCT03837639
Brief Title
Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease
Official Title
Effects of Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
December 10, 2022 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
Collaborators
University of Nove de Julho, Northumbria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Intermittent Claudication, Hypertension
Keywords
arm-crank, exercise training, cardiovascular function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm crank ergometer
Arm Type
Experimental
Arm Description
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 Title
Treadmill ergometer
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Arm ergometer
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Treadmill ergometer
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
ambulatory blood pressure
Description
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).
Time Frame
Change from baseline in ambulatory blood pressure at 12 weeks
Secondary Outcome Measure Information:
Title
Clinic blood pressure
Description
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).
Time Frame
Change from baseline in ambulatory blood pressure at 12 weeks
Title
Central blood pressure
Description
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).
Time Frame
Change from baseline in ambulatory blood pressure at 12 weeks
Title
Heart rate variability
Description
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).
Time Frame
Change from baseline in ambulatory blood pressure at 12 weeks
Title
Arterial stiffness
Description
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).
Time Frame
Change from baseline in arterial stiffness at 12 weeks
Title
Vascular function
Description
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).
Time Frame
Change from baseline in flow-mediated vasodilation at 12 weeks
Title
Walking capacity
Description
Six-minute walking test will be measured before and after 12 weeks of intervention
Time Frame
Change from baseline in walking distance at 12 weeks
Title
March in place
Description
Two-minute step test will be measured before and after 12 weeks of intervention
Time Frame
Change from baseline in the number of the steps at 12 weeks
Title
Subjective measurement of walking capacity
Description
Walking impairment questionnaire will be measured before and after 12 weeks of intervention
Time Frame
Change from baseline in the walking impairment questionnaire score after 12 weeks
Title
Subjective measurement of walking capacity compared to healthy subjects
Description
Walking estimated limitation calculated by history questionnaire will be measured before and after 12 weeks of intervention
Time Frame
Change from baseline in the Walking estimated limitation calculated by history questionnaire score after 12 weeks
Title
Overall strength test
Description
Handgrip strength test will be measured before and after 12 weeks of intervention
Time Frame
Change from baseline in kgf of the handgrip test after 12 weeks
Title
Symptoms of intermittent claudication
Description
The Baltimore Activity Scale for Intermittent Claudication is a questionnaire that will be measured before and after 12 weeks of intervention.
Time Frame
Change from baseline in the Baltimore Activity Scale for Intermittent Claudication score after 12 weeks
Title
General functional capacity
Description
The Short Physical Performance Battery will be measured before and after 12 weeks of intervention.
Time Frame
Change from baseline in the Short Physical Performance Battery score after 12 weeks
Title
Specific quality of life of vascular patients
Description
The Vascular quality of life questionnaire will be measured before and after 12 weeks of intervention.
Time Frame
Change from baseline in the Vascular quality of life questionnaire score after 12 weeks
Title
General quality of life
Description
The World Health Organization Quality of Life questionnaire will be measured before and after 12 weeks of intervention
Time Frame
Change from baseline in the World Health Organization Quality of Life score after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raphael M Ritti-Dias, PhD
Phone
+551999406878
Email
raphaelritti@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marilia A Correia, PhD
Phone
+5511999711669
Email
marilia.correia@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélcio Kanegusuku, PhD
Organizational Affiliation
Israelite Institute for Education and Research
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Cucato, PhD
Phone
+5511967318023
Email
gabriel.grizzo@einstein.br
First Name & Middle Initial & Last Name & Degree
Gabriel Cucato, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are planing to share our data in the future.
IPD Sharing Time Frame
After publication of the main paper.
IPD Sharing Access Criteria
Ask to authors permision.
Citations:
PubMed Identifier
28012910
Citation
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.
Results Reference
background
PubMed Identifier
32829481
Citation
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.
Results Reference
derived

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

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