Peripheral Arterial DiseaseNCT03092336
Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity
A study testing Electrical Stimulation and Strength training in people with Peripheral Arterial Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Introduction: the peripheral obstructive arterial disease is an condition that affects around 15% of the world population interfering in muscle strength, life quality and functional capacity of patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Electrical Stimulation and Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PAD and IC.
- Age from 40 to 80 years.
- Stage I and II of Fontaine.
- Symptoms of Intermittent Claudication for at least 3 months with resting brachial index ≤ 0.90 in 1 or 2 legs
Who cannot join
- Critical ischemia in one of the lower limbs.
- Moderate or severe ulcers in one of the lower limbs. Orthopedic problems that prevent exercise or evaluation.
- Participation in other studies with rehabilitation.
- Decreased arterial hypertension.
- Decompensated Diabetes
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90640030
Márcio Garcia, MD, 0555133597434, mgmarciogarcia@gmail.com
Rosane M Nery, PhD, 0555133597634, rosane.nery@gmail.com
About this study
Official title: Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity on Patients With Peripheral Artery Disease: a Randomized Clinical Trial
Introduction: the peripheral obstructive arterial disease is an condition that affects around 15% of the world population interfering in muscle strength, life quality and functional capacity of patients.
Read the detailed description
Study aim: to assess three methods of physical training (strength training, aerobic training and electrical stimulation training) in muscle strength, functional capacity and life quality of patients with peripheral obstructive arterial disease
- Conditions
- Peripheral Arterial Disease
- Being tested
- Electrical Stimulation, Strength training
- Keywords
- Peripheral Arterial Disease, training
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulationOther
electrical stimulation training
Strength trainingOther
strength training group
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation | Experimental | The training with electrostimulation will be performed with the following intensity:
Medium frequency current: 2.500Hz Modulation frequency: up to 50Hz Time on / off: 1: 2 Average session time 10 to 15 min Being applied in the same muscle groups that will be trained in the group that will perform strength training. Receives: Other: Electrical Stimulation |
| Strength training | Experimental | There will be 10 exercises: upper limbs: Supine with dumbbells; High pulley pull; Alternating thread with dumbbells; Triceps dumbbell test; Lower limbs: knee extensor, squatting with body weight, plantar flexion, knee flexion and plantar dorsiflexion. The session time will be from 45 minutes to one hour 2 times weekly totaling at the end of the 12 weeks, 24 strength training sessions. Receives: Other: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiopulmonary exercise test
assess functional capacity
Measured: 13 months
Secondary outcomes (4)
WHOQOL Questionnaire
asses quality of life
Measured: 13 months
Brachial ultrasonography
endothelial function
Measured: 13 months
Analog scale of pain
assess pain intensity
Measured: 13 months
Repetition maximum strength test (1RM)
assess Muscle strengh
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startMay 2011
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio C Santos, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092336
- Sponsor's protocol ID
- 11-0566
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garcia LA. Epidemiology and pathophysiology of lower extremity peripheral arterial disease. J Endovasc Ther. 2006 Feb;13 Suppl 2:II3-9. doi: 10.1177/15266028060130S204.
PubMed 16472007Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available.
PubMed 17223489Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.
PubMed 11560536Gardner AW, Montgomery PS, Afaq A. Exercise performance in patients with peripheral arterial disease who have different types of exertional leg pain. J Vasc Surg. 2007 Jul;46(1):79-86. doi: 10.1016/j.jvs.2007.02.037. Epub 2007 May 30.
PubMed 17540534Chi YW, Jaff MR. Optimal risk factor modification and medical management of the patient with peripheral arterial disease. Catheter Cardiovasc Interv. 2008 Mar 1;71(4):475-89. doi: 10.1002/ccd.21401.
PubMed 18307227Makdisse M, Pereira Ada C, Brasil Dde P, Borges JL, Machado-Coelho GL, Krieger JE, Nascimento Neto RM, Chagas AC; Hearts of Brazil Study and Peripheral Arterial Disease Committee of the Brazilian Society of Cardiology/Funcor. Prevalence and risk factors associated with peripheral arterial disease in the Hearts of Brazil Project. Arq Bras Cardiol. 2008 Dec;91(6):370-82. doi: 10.1590/s0066-782x2008001800008.
PubMed 19142364Kullo IJ, Bailey KR, Kardia SL, Mosley TH Jr, Boerwinkle E, Turner ST. Ethnic differences in peripheral arterial disease in the NHLBI Genetic Epidemiology Network of Arteriopathy (GENOA) study. Vasc Med. 2003 Nov;8(4):237-42. doi: 10.1191/1358863x03vm511oa.
PubMed 15125483Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004 Aug 10;110(6):738-43. doi: 10.1161/01.CIR.0000137913.26087.F0. Epub 2004 Jul 19.
PubMed 15262830Garg PK, Tian L, Criqui MH, Liu K, Ferrucci L, Guralnik JM, Tan J, McDermott MM. Physical activity during daily life and mortality in patients with peripheral arterial disease. Circulation. 2006 Jul 18;114(3):242-8. doi: 10.1161/CIRCULATIONAHA.105.605246. Epub 2006 Jul 3.
PubMed 16818814Askew CD, Green S, Walker PJ, Kerr GK, Green AA, Williams AD, Febbraio MA. Skeletal muscle phenotype is associated with exercise tolerance in patients with peripheral arterial disease. J Vasc Surg. 2005 May;41(5):802-7. doi: 10.1016/j.jvs.2005.01.037.
PubMed 15886664Bendermacher BL, Willigendael EM, Teijink JA, Prins MH. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005263. doi: 10.1002/14651858.CD005263.pub2.
PubMed 16625633Murphy TP, Hirsch AT, Ricotta JJ, Cutlip DE, Mohler E, Regensteiner JG, Comerota AJ, Cohen DJ; CLEVER Steering Committee. The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods. J Vasc Surg. 2008 Jun;47(6):1356-63. doi: 10.1016/j.jvs.2007.12.048. Epub 2008 Apr 25.
PubMed 18440181Andreozzi GM, Leone A, Laudani R, Deinite G, Martini R. Acute impairment of the endothelial function by maximal treadmill exercise in patients with intermittent claudication, and its improvement after supervised physical training. Int Angiol. 2007 Mar;26(1):12-7.
PubMed 17353883European Stroke Organisation; Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E, Ostergren J, Poldermans D, Riambau V, Roffi M, Rother J, Sievert H, van Sambeek M, Zeller T; ESC Committee for Practice Guidelines. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011 Nov;32(22):2851-906. doi: 10.1093/eurheartj/ehr211. Epub 2011 Aug 26. No abstract available.
PubMed 21873417Treesak C, Kasemsup V, Treat-Jacobson D, Nyman JA, Hirsch AT. Cost-effectiveness of exercise training to improve claudication symptoms in patients with peripheral arterial disease. Vasc Med. 2004 Nov;9(4):279-85. doi: 10.1191/1358863x04vm570oa.
PubMed 15678620
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity on Patients With Peripheral Artery Disease: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03092336
- Acronym / sponsor ID
- 11-0566
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: the peripheral obstructive arterial disease is an condition that affects around 15% of the world population interfering in muscle strength, life quality and functional capacity of patients.
Detailed description
Study aim: to assess three methods of physical training (strength training, aerobic training and electrical stimulation training) in muscle strength, functional capacity and life quality of patients with peripheral obstructive arterial disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation | Experimental | Other: Electrical StimulationThe training with electrostimulation will be performed with the following intensity: Medium frequency current: 2.500Hz Modulation frequency: up to 50Hz Time on / off: 1: 2 Average session time 10 to 15 min Being applied in the same muscle groups that will be trained in the group that will perform strength training. |
| Strength training | Experimental | Other: Strength trainingThere will be 10 exercises: upper limbs: Supine with dumbbells; High pulley pull; Alternating thread with dumbbells; Triceps dumbbell test; Lower limbs: knee extensor, squatting with body weight, plantar flexion, knee flexion and plantar dorsiflexion. The session time will be from 45 minutes to one hour 2 times weekly totaling at the end of the 12 weeks, 24 strength training sessions. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PAD and IC.
- Age from 40 to 80 years.
- Stage I and II of Fontaine.
- Symptoms of Intermittent Claudication for at least 3 months with resting brachial index ≤ 0.90 in 1 or 2 legs
Key exclusion criteria (5 listed)
- Critical ischemia in one of the lower limbs.
- Moderate or severe ulcers in one of the lower limbs. Orthopedic problems that prevent exercise or evaluation.
- Participation in other studies with rehabilitation.
- Decreased arterial hypertension.
- Decompensated Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Stimulationelectrical stimulation training | Other | Electrical Stimulation |
| Strength trainingstrength training group | Other | Strength training |
Primary outcome
cardiopulmonary exercise test
Time frame: 13 months
assess functional capacity
4 secondary outcomes
WHOQOL Questionnaire
Time frame: 13 months
Brachial ultrasonography
Time frame: 13 months
Analog scale of pain
Time frame: 13 months
Repetition maximum strength test (1RM)
Time frame: 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Background: PubMed 16472007Garcia LA. Epidemiology and pathophysiology of lower extremity peripheral arterial disease. J Endovasc Ther. 2006 Feb;13 Suppl 2:II3-9. doi: 10.1177/15266028060130S204.
- Background: PubMed 17223489Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available.
- Background: PubMed 11560536Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.
- Background: PubMed 17540534Gardner AW, Montgomery PS, Afaq A. Exercise performance in patients with peripheral arterial disease who have different types of exertional leg pain. J Vasc Surg. 2007 Jul;46(1):79-86. doi: 10.1016/j.jvs.2007.02.037. Epub 2007 May 30.
- Background: PubMed 18307227Chi YW, Jaff MR. Optimal risk factor modification and medical management of the patient with peripheral arterial disease. Catheter Cardiovasc Interv. 2008 Mar 1;71(4):475-89. doi: 10.1002/ccd.21401.
- Background: PubMed 19142364Makdisse M, Pereira Ada C, Brasil Dde P, Borges JL, Machado-Coelho GL, Krieger JE, Nascimento Neto RM, Chagas AC; Hearts of Brazil Study and Peripheral Arterial Disease Committee of the Brazilian Society of Cardiology/Funcor. Prevalence and risk factors associated with peripheral arterial disease in the Hearts of Brazil Project. Arq Bras Cardiol. 2008 Dec;91(6):370-82. doi: 10.1590/s0066-782x2008001800008.
- Background: PubMed 15125483Kullo IJ, Bailey KR, Kardia SL, Mosley TH Jr, Boerwinkle E, Turner ST. Ethnic differences in peripheral arterial disease in the NHLBI Genetic Epidemiology Network of Arteriopathy (GENOA) study. Vasc Med. 2003 Nov;8(4):237-42. doi: 10.1191/1358863x03vm511oa.
- Background: PubMed 15262830Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004 Aug 10;110(6):738-43. doi: 10.1161/01.CIR.0000137913.26087.F0. Epub 2004 Jul 19.
- Background: PubMed 16818814Garg PK, Tian L, Criqui MH, Liu K, Ferrucci L, Guralnik JM, Tan J, McDermott MM. Physical activity during daily life and mortality in patients with peripheral arterial disease. Circulation. 2006 Jul 18;114(3):242-8. doi: 10.1161/CIRCULATIONAHA.105.605246. Epub 2006 Jul 3.
- Background: PubMed 15886664Askew CD, Green S, Walker PJ, Kerr GK, Green AA, Williams AD, Febbraio MA. Skeletal muscle phenotype is associated with exercise tolerance in patients with peripheral arterial disease. J Vasc Surg. 2005 May;41(5):802-7. doi: 10.1016/j.jvs.2005.01.037.
- Background: PubMed 16625633Bendermacher BL, Willigendael EM, Teijink JA, Prins MH. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005263. doi: 10.1002/14651858.CD005263.pub2.
- Background: PubMed 18440181Murphy TP, Hirsch AT, Ricotta JJ, Cutlip DE, Mohler E, Regensteiner JG, Comerota AJ, Cohen DJ; CLEVER Steering Committee. The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods. J Vasc Surg. 2008 Jun;47(6):1356-63. doi: 10.1016/j.jvs.2007.12.048. Epub 2008 Apr 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio C Santos, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation and Strength training in people with Peripheral Arterial Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Márcio Garcia, MD (05551597634, mgmarciogarcia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiopulmonary exercise test (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092336, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.