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

NCT03837639 | Unknown DMC

• 1 other identifier: PAD01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Hypertension

Keywords

arm-crank; exercise training; cardiovascular function

Outcome Measures

Primary Outcomes (1)

• 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).

  Change from baseline in ambulatory blood pressure at 12 weeks

Secondary Outcomes (14)

• Clinic blood pressure

  Change from baseline in ambulatory blood pressure at 12 weeks

• Central blood pressure

  Change from baseline in ambulatory blood pressure at 12 weeks

• Heart rate variability

  Change from baseline in ambulatory blood pressure at 12 weeks

• Arterial stiffness

  Change from baseline in arterial stiffness at 12 weeks

• Vascular function

  Change from baseline in flow-mediated vasodilation at 12 weeks

Study Arms (3)

Arm crank ergometer

EXPERIMENTAL

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

Treadmill ergometer

EXPERIMENTAL

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

Control group

OTHER

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

Interventions

Arm ergometer OTHER

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 ergometer

Treadmill ergometer OTHER

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.

Treadmill ergometer

Control group OTHER

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.

Control group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• University of Nove de Julho: collaborator
• Northumbria University: collaborator

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 28012910 BACKGROUND

• Costa RM, Kanegusuku H, Cucato GG, Wolosker N, Ritti-Dias RM, Correia MA. Arm Crank Exercise Training Improves Ambulatory Blood Pressure in Patients With Symptomatic Peripheral Artery Disease: Randomized Controlled Trial. J Cardiopulm Rehabil Prev. 2024 Mar 1;44(2):145-147. doi: 10.1097/HCR.0000000000000829. Epub 2023 Nov 30. No abstract available.

  PMID: 38032247 DERIVED

• 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.

  PMID: 32829481 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Hypertension

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hélcio Kanegusuku, PhD

  Israelite Institute for Education and Research

  STUDY CHAIR

Central Study Contacts

Raphael M Ritti-Dias, PhD

CONTACT

+551999406878; raphaelritti@gmail.com

Marilia A Correia, PhD

CONTACT

+5511999711669; marilia.correia@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 12, 2019
• Study Start: June 10, 2019
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2023
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the main paper.
• Access Criteria: Ask to authors permision.

Locations

BR (1)