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

Not Applicable

• Conditions: Peripheral Arterial Disease; Intermittent Claudication; Hypertension

• Registration Number: NCT03837639
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2019-06-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-07
• Primary Completion: 2022-12-10
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ambulatory blood pressure	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

Name	Time	Method
March in place	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	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	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
Central blood pressure	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).
General functional capacity	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.
Arterial stiffness	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).
Overall strength test	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
Clinic blood pressure	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).
Symptoms of intermittent claudication	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.
Heart rate variability	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).
Vascular function	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	Change from baseline in walking distance at 12 weeks	Six-minute walking test will be measured before and after 12 weeks of intervention
Specific quality of life of vascular patients	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	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

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil