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Decrease in Blood Pressure in PARQVE

12. august 2019 oppdatert av: Marcia Uchoa Rezende, University of Sao Paulo General Hospital
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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

63

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Control group

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.
Atferdsmessig: ABPM
Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study
Atferdsmessig: The arterial stiffness and endothelial reactivity
The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study
Atferdsmessig: Euroqol EQ-5D-5L
Answer Euroqol EQ-5D-5L at baseline and at the end of the study
Atferdsmessig: Lectures about knee OA
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).
Eksperimentell: Continuous group
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.
Atferdsmessig: ABPM
Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study
Atferdsmessig: The arterial stiffness and endothelial reactivity
The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study
Atferdsmessig: Euroqol EQ-5D-5L
Answer Euroqol EQ-5D-5L at baseline and at the end of the study
Atferdsmessig: Lectures about knee OA
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).
Atferdsmessig: Continuous intensity exercise
40 min of treadmill physical exercise (40 min on treadmill at 60% of reserve heart rate.)
Eksperimentell: Interval group
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.
Atferdsmessig: ABPM
Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study
Atferdsmessig: The arterial stiffness and endothelial reactivity
The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study
Atferdsmessig: Euroqol EQ-5D-5L
Answer Euroqol EQ-5D-5L at baseline and at the end of the study
Atferdsmessig: Lectures about knee OA
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).
Atferdsmessig: Exercises with varying intensity and interval
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effects of high intensity exercise on blood pressure in individuals undergoing treatment for knee osteoarthritis
Tidsramme: 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.
16 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effects of high intensity exercise on quality of life
Tidsramme: 16 weeks
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)
16 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Sao Paulo General Hospital

Etterforskere

  • Hovedetterforsker: Guilherme Ocampos, MD, University of Sao Paulo General Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. oktober 2019

Primær fullføring (Forventet)

28. februar 2020

Studiet fullført (Forventet)

31. mars 2020

Datoer for studieregistrering

Først innsendt

2. august 2019

Først innsendt som oppfylte QC-kriteriene

6. august 2019

Først lagt ut (Faktiske)

9. august 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CAPPesq 04019418700000068

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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