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Decrease in Blood Pressure in PARQVE

Primary Purpose

Knee Osteoarthritis, Blood Pressure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ABPM
The arterial stiffness and endothelial reactivity
Euroqol EQ-5D-5L
Lectures about knee OA
Continuous intensity exercise
Exercises with varying intensity and interval
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Blood Pressure, HIIT

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women diagnosed with OAJ and SAH using antihypertensive medications
  • Classified as Kelgreen and Lawrence grades I to III (K-L), ie any degree of gonarthritis without obliteration of the joint space.
  • Indication of clinical treatment of OA.
  • Patients not submitted to previous lower limb arthroplasty.
  • Patients not submitted to knee infiltration up to 6 months before study.
  • Patients without personal history of cognitive, psychiatric and / or neurological disorders, whose symptoms presented at the time of the evaluation are related or significantly interfere with the functions of attention, memory, logical reasoning, understanding, in order to impair the assimilation of the given guidelines.
  • Patients who have not been doing regular physical activity (more than once a week) for the past 6 months.
  • Patients able to perform physical activity from a cardiological point of view
  • Ability to read, understand and answer the questionnaires.

Exclusion Criteria:

- Missing interventions and not performing the tasks determined by professionals.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Control group

    Continuous group

    Interval group

    Arm Description

    Two days of lectures about knee OA, but will also come to the hospital after the first class to consult about nutritional habits to be improved; therapy session with the psychologists, sessions with the physical therapy team; sessions with the physical educators team. They will be submitted to 24-hour ambulatory blood pressure monitoring (ABPM) at baseline and at the end fo the study; The arterial stiffness and endothelial reactivity will be assessed by measurement of the carotid-femoral pulse wave velocity by means of a non-invasive automatic device at baseline and at the end fo the study; Answer EQ-5D-5L at baseline and at the end fo the study.

    Two days of lectures about knee OA, but will also come to the hospital after the first class to consult about nutritional habits to be improved; therapy session with the psychologists, sessions with the physical therapy team; sessions with the physical educators team. The supervised exercise sessions will consist of 10 min of warm-up stretching exercises, 40 min of treadmill (40 min on treadmill at 60% of reserve heart rate), 20 min of sub-maximal strength training and 10 min of cooling exercises. They will be submitted to 24-hour ambulatory blood pressure monitoring (ABPM) at baseline and at the end of the study. The arterial stiffness and endothelial reactivity will be assessed by measurement of the carotid-femoral pulse wave velocity by means of a non-invasive automatic device at baseline and at the end of the study.

    Two days of lectures about knee OA, but will also come to the hospital after the first class to consult about nutritional habits to be improved; therapy session with the psychologists, sessions with the physical therapy team; sessions with the physical educators team. The supervised exercise sessions will consist of 10 min of warm-up stretching exercises, 40 min of treadmill (40 min on treadmill with alternating intensity between 50% and 80%) of HR, resulting in an average load of 60% ((50% 2) + 80% 3)), 20 min of sub-maximal strength training and 10 min of cooling exercises. They will be submitted to 24-hour ambulatory blood pressure monitoring (ABPM) at baseline and at the end of the study. The arterial stiffness and endothelial reactivity will be assessed by measurement of the carotid-femoral pulse wave velocity by means of a non-invasive automatic device at baseline and at the end of the study.

    Outcomes

    Primary Outcome Measures

    Effects of high intensity exercise on blood pressure in individuals undergoing treatment for knee osteoarthritis
    To assess the effect of high intensity versus continuous interval training of moderate intensity associated with an educational program on resting blood pressure.

    Secondary Outcome Measures

    Effects of high intensity exercise on quality of life
    Evaluate whether the high-intensity interval training associated with an educational program improves the quality of life evaluated through the Euroqol (ranging from 0 to 1, with higher score indicating better)

    Full Information

    First Posted
    August 2, 2019
    Last Updated
    August 12, 2019
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04052308
    Brief Title
    Decrease in Blood Pressure in PARQVE
    Official Title
    Decrease in Blood Pressure in PARQVE
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    February 28, 2020 (Anticipated)
    Study Completion Date
    March 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The tripod of OA clinical treatment is education, weight loss and exercise. A sedentary lifestyle has been characterized as an independent risk factor for cardiovascular disease. Studies have shown the inverse association between the level of physical activity and the incidence of cardiovascular disease. High Intensity Interval Training (HIIT), which consists of repeated high-intensity exercise sessions interspersed with passive recovery. Active, has been studied as a new therapeutic approach and has been shown to be effective in controlling blood pressure (BP) and arterial stiffness in treated hypertensive individuals. HIIT training has also been shown to be able to reverse the hemodynamic, metabolic and hormonal changes that are involved in the pathophysiology of essential hypertension, leading to improved arterial stiffness and BP response, endothelin-1 and nitrite / nitrate to exercise, increased cardiorespiratory fitness when compared to moderate-intensity continuous exercise in young women with a family history of essential hypertension. Six weeks of HIIT training (3 times / week) reduced body fat and waist circumference in young women. , while increasing fat-free mass, maximum running speed and aerobic fitness. Two recent studies evaluating body weight change in overweight patients have shown that HIIT training is comparable to moderate-intensity continuous exercise, but HIIT is more efficient compared to time spent training, which may facilitate the inclusion of daily routine training of patients. Previous work performed by the authors patients undergoing an education and physical activity program showed improvement in WOMAC. The investigators believe that the inclusion of an HIIT training protocol may lead to improved BP and hemodynamic variables in patients with knee osteoarthritis. To evaluate the effect of high intensity interval physical training associated with an educational program on BP, hemodynamic variables of individuals undergoing treatment for knee OA. 63 patients with knee OA will be randomized into 3 groups: interval exercise (21), continuous exercise (21) and control (21). Patients will be evaluated for BP using ABPM, arterial stiffness and endothelial reactivity by measuring carotid-femoral pulse wave velocity and quality of life using the Euroqol scale.
    Detailed Description
    High Intensity Interval Training (HIIT), which consists of repeated high intensity exercise sessions interspersed with passive / active recovery, has been studied as a new approach to hypertension therapy and systemic arterial hypertension. HIIT training has also been shown to be able to reverse how the hemodynamic, metabolic and hormonal changes that are involved in the physiology of essential hypertension, leading to improved arterial stiffness and BP response, endothelin-1 and nitrite / nitrate to exercise, Increased cardiorespiratory capacity when moderate-intensity continuous exercise was performed in young women with a history of essential arterial hypertension. Six weeks of HIIT training (3 times / week) reduced body fat and waist circumference in young women while increasing fat-free mass, maximum running speed, and aerobic fitness. Two recent studies evaluating body constitution change in overweight patients have shown that HIIT training is comparable to moderate-intensity continuous exercise, but HIIT is more efficient compared to the time spent during training, and HIIT can deliver savings of approximately 40% of the training time, which can facilitate the inclusion of training in the daily routine of patients. In previous work by the investigators, patients undergoing an education and physical activity program showed improvement in WOMAC. Researchers believe that the inclusion of an HIIT training protocol may lead to improved BP and hemodynamic variables in patients with knee osteoarthritis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Blood Pressure
    Keywords
    Knee Osteoarthritis, Blood Pressure, HIIT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    63 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Two days of lectures about knee OA, but will also come to the hospital after the first class to consult about nutritional habits to be improved; therapy session with the psychologists, sessions with the physical therapy team; sessions with the physical educators team. They will be submitted to 24-hour ambulatory blood pressure monitoring (ABPM) at baseline and at the end fo the study; The arterial stiffness and endothelial reactivity will be assessed by measurement of the carotid-femoral pulse wave velocity by means of a non-invasive automatic device at baseline and at the end fo the study; Answer EQ-5D-5L at baseline and at the end fo the study.
    Arm Title
    Continuous group
    Arm Type
    Experimental
    Arm Description
    Two days of lectures about knee OA, but will also come to the hospital after the first class to consult about nutritional habits to be improved; therapy session with the psychologists, sessions with the physical therapy team; sessions with the physical educators team. The supervised exercise sessions will consist of 10 min of warm-up stretching exercises, 40 min of treadmill (40 min on treadmill at 60% of reserve heart rate), 20 min of sub-maximal strength training and 10 min of cooling exercises. They will be submitted to 24-hour ambulatory blood pressure monitoring (ABPM) at baseline and at the end of the study. The arterial stiffness and endothelial reactivity will be assessed by measurement of the carotid-femoral pulse wave velocity by means of a non-invasive automatic device at baseline and at the end of the study.
    Arm Title
    Interval group
    Arm Type
    Experimental
    Arm Description
    Two days of lectures about knee OA, but will also come to the hospital after the first class to consult about nutritional habits to be improved; therapy session with the psychologists, sessions with the physical therapy team; sessions with the physical educators team. The supervised exercise sessions will consist of 10 min of warm-up stretching exercises, 40 min of treadmill (40 min on treadmill with alternating intensity between 50% and 80%) of HR, resulting in an average load of 60% ((50% 2) + 80% 3)), 20 min of sub-maximal strength training and 10 min of cooling exercises. They will be submitted to 24-hour ambulatory blood pressure monitoring (ABPM) at baseline and at the end of the study. The arterial stiffness and endothelial reactivity will be assessed by measurement of the carotid-femoral pulse wave velocity by means of a non-invasive automatic device at baseline and at the end of the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ABPM
    Intervention Description
    Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study
    Intervention Type
    Behavioral
    Intervention Name(s)
    The arterial stiffness and endothelial reactivity
    Intervention Description
    The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study
    Intervention Type
    Behavioral
    Intervention Name(s)
    Euroqol EQ-5D-5L
    Intervention Description
    Answer Euroqol EQ-5D-5L at baseline and at the end of the study
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lectures about knee OA
    Intervention Description
    Patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy team followed by 7 sessions with the physical educators team (once a week/4 weeks and once every two weeks, three times).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Continuous intensity exercise
    Intervention Description
    40 min of treadmill physical exercise (40 min on treadmill at 60% of reserve heart rate.)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercises with varying intensity and interval
    Intervention Description
    40 min of treadmill physical exercise ( 40 min on treadmill with alternating intensity between 50% (2 min) and 80% (1 min) of HR, resulting in an average load of 60% ((50% 2) + 80% / 3)), 20 min of sub-maximal strength training and 10 min of cooling exercises.
    Primary Outcome Measure Information:
    Title
    Effects of high intensity exercise on blood pressure in individuals undergoing treatment for knee osteoarthritis
    Description
    To assess the effect of high intensity versus continuous interval training of moderate intensity associated with an educational program on resting blood pressure.
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Effects of high intensity exercise on quality of life
    Description
    Evaluate whether the high-intensity interval training associated with an educational program improves the quality of life evaluated through the Euroqol (ranging from 0 to 1, with higher score indicating better)
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and women diagnosed with OAJ and SAH using antihypertensive medications Classified as Kelgreen and Lawrence grades I to III (K-L), ie any degree of gonarthritis without obliteration of the joint space. Indication of clinical treatment of OA. Patients not submitted to previous lower limb arthroplasty. Patients not submitted to knee infiltration up to 6 months before study. Patients without personal history of cognitive, psychiatric and / or neurological disorders, whose symptoms presented at the time of the evaluation are related or significantly interfere with the functions of attention, memory, logical reasoning, understanding, in order to impair the assimilation of the given guidelines. Patients who have not been doing regular physical activity (more than once a week) for the past 6 months. Patients able to perform physical activity from a cardiological point of view Ability to read, understand and answer the questionnaires. Exclusion Criteria: - Missing interventions and not performing the tasks determined by professionals.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Livia Abreu
    Phone
    1126612473
    Email
    murmedicina@outlook.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guilherme Ocampos, MD
    Organizational Affiliation
    University of São Paulo General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18279766
    Citation
    Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
    Results Reference
    background
    PubMed Identifier
    20170770
    Citation
    Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.
    Results Reference
    background
    PubMed Identifier
    27660931
    Citation
    Rillo O, Riera H, Acosta C, Liendo V, Bolanos J, Monterola L, Nieto E, Arape R, Franco LM, Vera M, Papasidero S, Espinosa R, Esquivel JA, Souto R, Rossi C, Molina JF, Salas J, Ballesteros F, Radrigan F, Guibert M, Reyes G, Chico A, Camacho W, Urioste L, Garcia A, Iraheta I, Gutierrez CE, Aragon R, Duarte M, Gonzalez M, Castaneda O, Angulo J, Coimbra I, Munoz-Louis R, Saenz R, Vallejo C, Briceno J, Acuna RP, De Leon A, Reginato AM, Moller I, Caballero CV, Quintero M. PANLAR Consensus Recommendations for the Management in Osteoarthritis of Hand, Hip, and Knee. J Clin Rheumatol. 2016 Oct;22(7):345-54. doi: 10.1097/RHU.0000000000000449.
    Results Reference
    background
    PubMed Identifier
    8667571
    Citation
    Physical activity and cardiovascular health. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health. JAMA. 1996 Jul 17;276(3):241-6.
    Results Reference
    background
    PubMed Identifier
    10982542
    Citation
    Tanaka H, Dinenno FA, Monahan KD, Clevenger CM, DeSouza CA, Seals DR. Aging, habitual exercise, and dynamic arterial compliance. Circulation. 2000 Sep 12;102(11):1270-5. doi: 10.1161/01.cir.102.11.1270.
    Results Reference
    background
    PubMed Identifier
    8141370
    Citation
    Cameron JD, Dart AM. Exercise training increases total systemic arterial compliance in humans. Am J Physiol. 1994 Feb;266(2 Pt 2):H693-701. doi: 10.1152/ajpheart.1994.266.2.H693.
    Results Reference
    background
    PubMed Identifier
    15692323
    Citation
    Kakiyama T, Sugawara J, Murakami H, Maeda S, Kuno S, Matsuda M. Effects of short-term endurance training on aortic distensibility in young males. Med Sci Sports Exerc. 2005 Feb;37(2):267-71. doi: 10.1249/01.mss.0000152733.12578.5a.
    Results Reference
    background
    PubMed Identifier
    20379194
    Citation
    Guimaraes GV, Ciolac EG, Carvalho VO, D'Avila VM, Bortolotto LA, Bocchi EA. Effects of continuous vs. interval exercise training on blood pressure and arterial stiffness in treated hypertension. Hypertens Res. 2010 Jun;33(6):627-32. doi: 10.1038/hr.2010.42. Epub 2010 Apr 9.
    Results Reference
    background
    PubMed Identifier
    20448634
    Citation
    Ciolac EG, Bocchi EA, Bortolotto LA, Carvalho VO, Greve JM, Guimaraes GV. Effects of high-intensity aerobic interval training vs. moderate exercise on hemodynamic, metabolic and neuro-humoral abnormalities of young normotensive women at high familial risk for hypertension. Hypertens Res. 2010 Aug;33(8):836-43. doi: 10.1038/hr.2010.72. Epub 2010 May 7.
    Results Reference
    background
    PubMed Identifier
    24905559
    Citation
    Hazell TJ, Hamilton CD, Olver TD, Lemon PW. Running sprint interval training induces fat loss in women. Appl Physiol Nutr Metab. 2014 Aug;39(8):944-50. doi: 10.1139/apnm-2013-0503. Epub 2014 Mar 18.
    Results Reference
    background
    PubMed Identifier
    28401638
    Citation
    Wewege M, van den Berg R, Ward RE, Keech A. The effects of high-intensity interval training vs. moderate-intensity continuous training on body composition in overweight and obese adults: a systematic review and meta-analysis. Obes Rev. 2017 Jun;18(6):635-646. doi: 10.1111/obr.12532. Epub 2017 Apr 11.
    Results Reference
    background
    PubMed Identifier
    28116314
    Citation
    Zhang H, Tong TK, Qiu W, Zhang X, Zhou S, Liu Y, He Y. Comparable Effects of High-Intensity Interval Training and Prolonged Continuous Exercise Training on Abdominal Visceral Fat Reduction in Obese Young Women. J Diabetes Res. 2017;2017:5071740. doi: 10.1155/2017/5071740. Epub 2017 Jan 1.
    Results Reference
    background
    PubMed Identifier
    23525435
    Citation
    Cornelissen VA, Smart NA. Exercise training for blood pressure: a systematic review and meta-analysis. J Am Heart Assoc. 2013 Feb 1;2(1):e004473. doi: 10.1161/JAHA.112.004473.
    Results Reference
    background
    PubMed Identifier
    7649586
    Citation
    Asmar R, Benetos A, Topouchian J, Laurent P, Pannier B, Brisac AM, Target R, Levy BI. Assessment of arterial distensibility by automatic pulse wave velocity measurement. Validation and clinical application studies. Hypertension. 1995 Sep;26(3):485-90. doi: 10.1161/01.hyp.26.3.485.
    Results Reference
    background

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