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

NCT ID: NCT03837639

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2023-12-10

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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Arm ergometer

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Treadmill ergometer

Intervention Type: 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.

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.

Group Type: OTHER

Control group

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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;

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hélcio Kanegusuku, PhD

Role: STUDY_CHAIR

Israelite Institute for Education and Research

Locations

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Raphael M Ritti-Dias, PhD

Role: CONTACT

raphaelritti@gmail.com

+551999406878

Marilia A Correia, PhD

Role: CONTACT

marilia.correia@live.com

+5511999711669

Facility Contacts

Gabriel Cucato, PhD

Role: primary

gabriel.grizzo@einstein.br

+5511967318023

References

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.

Reference Type: BACKGROUND

PMID: 28012910 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38032247 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32829481 (View on PubMed)

Other Identifiers

PAD01

Identifier Type: -

Identifier Source: org_study_id