Knee OsteoarthritisNCT04052308
Decrease in Blood Pressure in PARQVE
A study testing ABPM, The arterial stiffness and endothelial reactivity and Euroqol EQ-5D-5L in people with Knee Osteoarthritis and Blood Pressure, run by University of Sao Paulo General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis, Blood Pressure
- What is being tested?
- ABPM, The arterial stiffness and endothelial reactivity and Euroqol EQ-5D-5L
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 31 Mar 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- Missing interventions and not performing the tasks determined by professionals.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Blood Pressure
- Being tested
- ABPM, The arterial stiffness and endothelial reactivity, Euroqol EQ-5D-5L, Lectures about knee OA, Continuous intensity exercise
- Keywords
- Knee Osteoarthritis, Blood Pressure, HIIT
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABPMBehavioural
Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study
The arterial stiffness and endothelial reactivityBehavioural
The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study
Euroqol EQ-5D-5LBehavioural
Answer Euroqol EQ-5D-5L at baseline and at the end of the study
Lectures about knee OABehavioural
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).
Continuous intensity exerciseBehavioural
40 min of treadmill physical exercise (40 min on treadmill at 60% of reserve heart rate.)
Exercises with varying intensity and intervalBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Behavioral: ABPM; Behavioral: The arterial stiffness and endothelial reactivity; Behavioral: Euroqol EQ-5D-5L; Behavioral: Lectures about knee OA |
| Continuous group | Experimental | 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. Receives: Behavioral: ABPM; Behavioral: The arterial stiffness and endothelial reactivity; Behavioral: Euroqol EQ-5D-5L; Behavioral: Lectures about knee OA; Behavioral: Continuous intensity exercise |
| Interval group | Experimental | 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. Receives: Behavioral: ABPM; Behavioral: The arterial stiffness and endothelial reactivity; Behavioral: Euroqol EQ-5D-5L; Behavioral: Lectures about knee OA; Behavioral: Exercises with varying intensity and interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (1)
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)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Oct 2019 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Uchoa Rezende, University of Sao Paulo General Hospital
- Investigators
- Guilherme Ocampos, MD, Principal investigator, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052308
- Sponsor's protocol ID
- CAPPesq 04019418700000068
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18279766Zhang 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.
PubMed 20170770Rillo 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.
PubMed 27660931Physical activity and cardiovascular health. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health. JAMA. 1996 Jul 17;276(3):241-6.
PubMed 8667571Tanaka 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.
PubMed 10982542Cameron 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.
PubMed 8141370Kakiyama 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.
PubMed 15692323Guimaraes 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.
PubMed 20379194Ciolac 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.
PubMed 20448634Hazell 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.
PubMed 24905559Wewege 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.
PubMed 28401638Zhang 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.
PubMed 28116314Cornelissen 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.
PubMed 23525435Asmar 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.
PubMed 7649586
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decrease in Blood Pressure in PARQVE
- ClinicalTrials.gov ID
- NCT04052308
- Acronym / sponsor ID
- CAPPesq 04019418700000068
- Conditions
- Knee Osteoarthritis, Blood Pressure
- Keywords
- Knee Osteoarthritis, Blood Pressure, HIIT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 9 Aug 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: ABPM, Behavioral: The arterial stiffness and endothelial reactivity, Behavioral: Euroqol EQ-5D-5L, Behavioral: Lectures about knee OATwo 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. |
| Continuous group | Experimental | Behavioral: ABPM, Behavioral: The arterial stiffness and endothelial reactivity, Behavioral: Euroqol EQ-5D-5L, Behavioral: Lectures about knee OA, Behavioral: Continuous intensity exerciseTwo 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. |
| Interval group | Experimental | Behavioral: ABPM, Behavioral: The arterial stiffness and endothelial reactivity, Behavioral: Euroqol EQ-5D-5L, Behavioral: Lectures about knee OA, Behavioral: Exercises with varying intensity and intervalTwo 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- Missing interventions and not performing the tasks determined by professionals.
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 |
|---|---|---|
| ABPMAmbulatory Blood Pressure Monitoring at Baseline and at the end of the study | Behavioural | Continuous group, Control group, Interval group |
| The arterial stiffness and endothelial reactivityThe arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study | Behavioural | Continuous group, Control group, Interval group |
| Euroqol EQ-5D-5LAnswer Euroqol EQ-5D-5L at baseline and at the end of the study | Behavioural | Continuous group, Control group, Interval group |
| Lectures about knee OAPatients 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). | Behavioural | Continuous group, Control group, Interval group |
| Continuous intensity exercise40 min of treadmill physical exercise (40 min on treadmill at 60% of reserve heart rate.) | Behavioural | Continuous group |
| Exercises with varying intensity and interval40 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. | Behavioural | Interval group |
Primary outcome
Effects of high intensity exercise on blood pressure in individuals undergoing treatment for knee osteoarthritis
Time frame: 16 weeks
To assess the effect of high intensity versus continuous interval training of moderate intensity associated with an educational program on resting blood pressure.
1 secondary outcome
Effects of high intensity exercise on quality of life
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Background: PubMed 18279766Zhang 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.
- Background: PubMed 20170770Zhang 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.
- Background: PubMed 27660931Rillo 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.
- Background: PubMed 8667571Physical activity and cardiovascular health. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health. JAMA. 1996 Jul 17;276(3):241-6.
- Background: PubMed 10982542Tanaka 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.
- Background: PubMed 8141370Cameron 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.
- Background: PubMed 15692323Kakiyama 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.
- Background: PubMed 20379194Guimaraes 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.
- Background: PubMed 20448634Ciolac 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.
- Background: PubMed 24905559Hazell 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.
- Background: PubMed 28401638Wewege 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.
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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.
Guilherme Ocampos, MD principal investigator
University of São Paulo General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ABPM, The arterial stiffness and endothelial reactivity and Euroqol EQ-5D-5L in people with Knee Osteoarthritis and Blood Pressure, run by University of Sao Paulo General Hospital.
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 9 inclusion and 1 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Livia Abreu (1126612473, murmedicina@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of high intensity exercise on blood pressure in individuals undergoing treatment for knee osteoarthritis (time frame: 16 weeks). 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 NCT04052308, which also lists 14 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 14 Aug 2019.