Decrease in Blood Pressure in PARQVE

NCT04052308 | Unknown

• 1 other identifier: CAPPesq 04019418700000068
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis; Blood Pressure

Keywords

Knee Osteoarthritis; Blood Pressure; HIIT

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (1)

• Effects of high intensity exercise on quality of life

  16 weeks

Study Arms (3)

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.

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.

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.

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

Interventions

ABPM BEHAVIORAL

Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study

Continuous group; Control group; Interval group

The arterial stiffness and endothelial reactivity BEHAVIORAL

The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study

Continuous group; Control group; Interval group

Euroqol EQ-5D-5L BEHAVIORAL

Answer Euroqol EQ-5D-5L at baseline and at the end of the study

Continuous group; Control group; Interval group

Lectures about knee OA BEHAVIORAL

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 group; Control group; Interval group

Continuous intensity exercise BEHAVIORAL

40 min of treadmill physical exercise (40 min on treadmill at 60% of reserve heart rate.)

Continuous group

Exercises with varying intensity and interval BEHAVIORAL

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.

Interval group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (14)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Guilherme Ocampos, MD

  University of São Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Livia Abreu

CONTACT

1126612473; murmedicina@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor in Orthopedics and Traumatology

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 9, 2019
• Study Start: October 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 31, 2020
• Last Updated: August 14, 2019

Record last verified: 2019-08