Clinical trial NCT03837639: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Hypertension
Keywords: arm-crank
exercise training
cardiovascular function
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: University of Nove de Julho
name: Northumbria University
First posted: 2019-02-12
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: ambulatory blood pressure
timeFrame: Change from baseline in ambulatory blood pressure at 12 weeks
Secondary outcomes:
measure: Clinic blood pressure
timeFrame: Change from baseline in ambulatory blood pressure at 12 weeks
measure: Central blood pressure
timeFrame: Change from baseline in ambulatory blood pressure at 12 weeks
measure: Heart rate variability
timeFrame: Change from baseline in ambulatory blood pressure at 12 weeks
measure: Arterial stiffness
timeFrame: Change from baseline in arterial stiffness at 12 weeks
measure: Vascular function
timeFrame: Change from baseline in flow-mediated vasodilation at 12 weeks
measure: Walking capacity
timeFrame: Change from baseline in walking distance at 12 weeks
measure: March in place
timeFrame: Change from baseline in the number of the steps at 12 weeks
measure: Subjective measurement of walking capacity
timeFrame: Change from baseline in the walking impairment questionnaire score after 12 weeks
measure: Subjective measurement of walking capacity compared to healthy subjects
timeFrame: Change from baseline in the Walking estimated limitation calculated by history questionnaire score after 12 weeks
measure: Overall strength test
timeFrame: Change from baseline in kgf of the handgrip test after 12 weeks
measure: Symptoms of intermittent claudication
timeFrame: Change from baseline in the Baltimore Activity Scale for Intermittent Claudication score after 12 weeks
measure: General functional capacity
timeFrame: Change from baseline in the Short Physical Performance Battery score after 12 weeks
measure: Specific quality of life of vascular patients
timeFrame: Change from baseline in the Vascular quality of life questionnaire score after 12 weeks
measure: General quality of life
timeFrame: Change from baseline in the World Health Organization Quality of Life score after 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Israelite Institute for Education and Research
name: Hélcio Kanegusuku, PhD
role: STUDY_CHAIR
References:
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.
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.