Hypertension, Intermittent Claudication, Peripheral Arterial Disease
Conditions
Keywords
arm-crank, exercise training, cardiovascular function
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.
Interventions
OTHERArm 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
OTHERTreadmill 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.
OTHERControl 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.
Sponsors
University of Nove de Julho
Northumbria University
Hospital Israelita Albert Einstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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 |
| 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 |
| 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). |
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
Countries
Brazil
Contacts
Primary ContactRaphael M Ritti-Dias, PhD
Backup ContactMarilia A Correia, PhD
Outcome results
None listed