Decrease in Blood Pressure in PARQVE

August 12, 2019 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: ABPM
Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study
Behavioral: The arterial stiffness and endothelial reactivity
The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study
Behavioral: Euroqol EQ-5D-5L
Answer Euroqol EQ-5D-5L at baseline and at the end of the study
Behavioral: 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).
Experimental: 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.
Behavioral: ABPM
Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study
Behavioral: The arterial stiffness and endothelial reactivity
The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study
Behavioral: Euroqol EQ-5D-5L
Answer Euroqol EQ-5D-5L at baseline and at the end of the study
Behavioral: 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).
Behavioral: Continuous intensity exercise
40 min of treadmill physical exercise (40 min on treadmill at 60% of reserve heart rate.)
Experimental: 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.
Behavioral: ABPM
Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study
Behavioral: The arterial stiffness and endothelial reactivity
The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study
Behavioral: Euroqol EQ-5D-5L
Answer Euroqol EQ-5D-5L at baseline and at the end of the study
Behavioral: 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).
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of high intensity exercise on quality of life
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

February 28, 2020

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPPesq 04019418700000068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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