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NCT04052308
Decrease in Blood Pressure in PARQVE
NA trial testing ABPM in Knee Osteoarthritis in 63 participants. Status unknown.
28 February 2020
Quick facts
| Lead sponsor | University of Sao Paulo General Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 63 |
| Start date | 1 October 2019 |
| Primary completion | 28 February 2020 |
| Estimated completion | 31 March 2020 |
Drugs / interventions tested
- ABPM
- The arterial stiffness and endothelial reactivity
- Euroqol EQ-5D-5L
- Lectures about knee OA
- Continuous intensity exercise
- Exercises with varying intensity and interval
Conditions studied
- Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
- Blood Pressure — all drugs for Blood Pressure →
Sponsor
University of Sao Paulo General Hospital
Who can join
60 and older, any sex, with Knee Osteoarthritis or Blood Pressure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04052308
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04052308 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo General Hospital
- Last refreshed: 14 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04052308.
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