Knee Osteoarthriis and Oxidative StressNCT03927339
Do Obese Patients With Primary Knee Osteoarthritis Benefit From a Single Bout of Moderate Intensity Aerobic Exercise?
An observational study of Knee Osteoarthriis and Oxidative Stress, run by Mansoura University at 1 site in Egypt.
Trial summary
Background: Obesity and degenerative joint disease are typically concomitant . Each are in the course of aerobic focus and excited inflammatory response. Exercise is taken into account a considerable treatment in rehabilitation of each conditions. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthriis and Oxidative Stress
- What is being tested?
- pre and post excercise group
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jun 2019to 1 Oct 2019
- Phase
- Observational
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: a cohort of egyptian patients suffering from obesity and knee osteoarthritis
Who may be able to join
- : knee OA with obesity; sedentary with no previous education ; ability to understand and follow commands; and ability to walk independently.
Who cannot join
- Medical conditions contraindicating moderate aerobic exercising (as determined through prescreening questions, i.e., cardiac or coronary artery disease as ischemic cardiomyopathy , chronic lung disease, asthma, uncontrolled hypertension), inability to exercise via treadmill(i.e. no neuromuscular or lower extremity conditions or any other medical contraindication that could prevent them from floor walking as upset affecting movement of the pelvic arch or pace , story of previous hip or knee operating room ,periarticular fractures, or lower limb injuries).History of recent reefer transmission or acute joint lighting .History of recent joint injection (steroid, hyaluronic acid , etc.) within 6 calendar week of study. Ingestion of antioxidant supplementation and the use of psychotropic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Exercise and Knee Osteoarthritis
Background: Obesity and degenerative joint disease are typically concomitant . Each are in the course of aerobic focus and excited inflammatory response. Exercise is taken into account a considerable treatment in rehabilitation of each conditions. nevertheless most of literature reported the good thing about regular exercise, whereas there's dearth regarding the consequence of base hit low to centrist usage session .
Objective:Hence, this report aimed to analyze the attainable effects of a single bout of moderate excercise in obese patients with KOA.
Methods:Thirty four rotund OA untrained semantic role and thirty age and sex matched healthy controls were registered during this sketch . OA patients were allotted to single session of low to moderate exercise on treadmill whereas controls remained unexercised. Perceived pain, GR activity, IL-6 , CRP, fasting blood glucose and lipid profile were assessed at baseline , once exercise and 24h after. Meanwhile, WOMAC score determined at baseline and once 24h.
Read the detailed description
Study population:
This is an observational study a cohort of sedentary Egyptian patients included thirty four obese patients role diagnosed with primary human knee joint OA according to the criteria of the American College of Rheumatology (ACR)( 8).were selected from those attending the outpatient clinics of Rheumatology and Rehabilitation Department , Mansoura University (28 females and 6 males; mean age, 46.94 ± 10.84 years; trunk mass index, 40.91 ± 10.09 kg/m2). In addition, 30 healthy volunteers with no clinical and radiological evidence of OA(22 females and8 males; mean age,50.7 ±10.5 ; BMI 24.3±1.3)participated in the discipline .
Inclusion criteria: knee OA with obesity; sedentary with no previous education ; ability to understand and follow commands; and ability to walk independently.
Exclusion criteria: Medical conditions contraindicating moderate aerobic exercising (as determined through prescreening questions, i.e., cardiac or coronary artery disease as ischemic cardiomyopathy , chronic lung disease, asthma, uncontrolled hypertension), inability to exercise via treadmill(i.e. no neuromuscular or lower extremity conditions or any other medical contraindication that could prevent them from floor walking as upset affecting movement of the pelvic arch or pace , story of previous hip or knee operating room ,periarticular fractures, or lower limb injuries).History of recent reefer transmission or acute joint lighting .History of recent joint injection (steroid, hyaluronic acid , etc.) within 6 calendar week of study. Ingestion of antioxidant supplementation and the use of psychotropic agents.
Participants underwent bilateral AP standing x ray to verify the presence and degree of human knee OA. X-rays were marked exploitation the Kellgren and Lawrence (K/L) scale for knee OA severity(9).Subjects with picture taking knee OA of KL grade ≥2 in a minimum of one knee were listed. The grading of the worst affected knee in every patient was used for knowledge analysis.
Physical examinations including age and body mass index (BMI) were obtained at the same visits at which radiographs were obtained. Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores of the OA patients were collected (10).
Treadmill Training Protocol
Each eligible participant in the patients group was then prospectively assigned to undergo exercise session of full-body-free weight treadmill training. Once the participants were prepped, they performed stretching for 5 min and slow walking for 3 min as a warm-up exercise before starting the training. Stretch was carried out similarly to all the subjects to quadriceps femoris and the hamstring. In the warm-up time period , it was enforced for 3 min at the speed of1 km/h. Then patients began the walking trials and walked at 1 to 1.34 m/s on an electric car treadmill (JACO fitness: JACO-212C).
Exercise intensity
For the purpose of this study, Metabolic Equivalents (METs) and Rate of Perceived Exertion (RPE) were used as guidelines to determine exercise intensity. Moderate aerobic exercise has been objectively defined as activity that generates energy expenditure of 3.0 to 6.0 (METs) (11).
To determine the intensity, time and frequency of exercise, it was set at low to moderate, that is between 40% and 60% of the maximum heart rate, from 12 to 14 rating of RPE. In addition, each subject was shown the 15 point Borg Rating of Perceived Exertion scale and instructed in its use. The RPE scale was mounted on the wall in front of the treadmill and easily visible to the subjects. Exercise instructions and measurements of associated Metabolic Equivalents (METs) were determined based upon previous studies which determined that walking on a level surface at 3.0 MPH equates to 3.3 METs and walking at 4.5 MPH generates 6.3 METs(12).
Participants walked at a pace of 2.5 to 3.0 MPH on a treadmill with zero incline for 30 min and they were instructed to walk at a pace that neither caused pain nor increased symptoms (13).
To minimize pain that may occur due to treadmill exercise, 5 min rest were allowed after 15 min of exercise. In the control group, the subjects remained at rest.
The present study was conducted in agreement with the guidelines of the Declaration of Helsinki. Written informed consent was received from every patient and healthy subject before participating in the study. This study was approved by the Institutional Research Board of the Faculty of Medicine, Mansoura University code R.18.04.137
Laboratory assays:
Blood samples were drawn before and once exercise (within 0.5 h once exercise,and at 24 h). All organic chemistry measurements were performed on frozen plasma samples obtained by activity of freshly drawn blood (3000 × g for 20minutes at 4∘C) and consequent storage at -70∘C. Blood macromolecule profiles, together with total cholesterol (TC), HDL cholesterol (HDL-C), calculated LDL cholesterol(LDL-C), and triglycerides (TG) concentrations were determined by protein assays., further as abstinence blood sugar level.
IL-6, CRP Serum concentrations of IL-6 were determined using sandwich high sensitivity ELISA kit for quantitative detection of human IL-6 according to manufacturer's protocol (Boster Immunoleader by Boster Biological Technology Co. Inc.). Detection of serum CRP was performed by Solid Phase Sandwich ELISA according to manufacturer's instructions (Quantikine Human CRP Immunoassay, R\&D systems)
Glutathione reductase assay:
Spectrophotometric determination of GR activity in the serum was measured as described by Calberg and Mannervic (14) using commercially available Glutathione Reductase Assay Kit(Sigma chemical company, St Louis, Missouri, USA). Glutathione reductase catalyzes the reduction of GSSG by oxidizing NADPH to NADP+. The decrease in absorbance was measured at 340.
- Conditions
- Knee Osteoarthriis and Oxidative Stress
- Being tested
- pre and post excercise group
- Keywords
- Osteoarthritis- Obesity- single aerobic exercise session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre and post excercise groupDiagnostic test
Treadmill Training Protocol
Each eligible participant in the patients group was then prospectively assigned to undergo exercise session of full-body-free weight treadmill training. Once the participants were prepped, they performed stretching for 5 min and slow walking for 3 min as a warm-up exercise before starting the training. Stretch was carried out similarly to all the subjects to quadriceps femoris and the hamstring. In the warm-up time period , it was enforced for 3 min at the speed of1 km/h. Then patients began the walking trials and walked at 1 to 1.34 m/s on an electric car treadmill (JACO fitness: JACO-212C).
| Study group | Role | What they receive |
|---|---|---|
| pre and post excercise group | Not described Receives: Diagnostic Test: pre and post excercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in degree of pain from base line
1-Pain Visual Analogue Scale: The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain(1
Measured: assessed immediately before excercise, 10 minutes after excercise and 24 hours after excercise
CHange in function from base line
Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores of the OA patients were collected (10).
Scores from the Western Ontario and Mc-Master University (WOMAC) OA index were used to assess pain, stiffness and function in OA patients [11]. Total WOMAC is the sum of 3 subscales scores. High WOMAC score indicates more pain and stiffness and severe functional limitation.
Measured: Assessed before excercise immediately,10 minutes after, excercise,24 hours after excercise
Secondary outcomes (4)
CHANGE INserum IL6 FROM BASE LINE,
Serum concentrations of IL-6 were determined using sandwich high sensitivity ELISA kit for quantitative detection of human IL-6 according to manufacturer's protocol (Boster Immunoleader by Boster Biological Technology Co. Inc.)
Measured: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise
change in serum C REACTIVE PROTEIN from base line
Detection of serum CRP was performed by Solid Phase Sandwich ELISA according to manufacturer's instructions (Quantikine Human CRP Immunoassay, R\&D systems)
Measured: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise
change inSERUM LIPID PROFILE from base line
Blood macromolecule profiles, together with total cholesterol (TC), HDL cholesterol (HDL-C), calculated LDL cholesterol(LDL-C), and triglycerides (TG) concentrations were determined by protein assays.,
Measured: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise
change in serum Glutathione reductase assay: from base line
Spectrophotometric determination of GR activity in the serum was measured as described by Calberg and Mannervic (14) using commercially available Glutathione Reductase Assay Kit(Sigma chemical company, St Louis, Missouri, USA). Glutathione reductase catalyzes the reduction of GSSG by oxidizing NADPH to NADP+. The decrease in absorbance was measured at 340.
Measured: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start29 Jun 2019
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthriis and Oxidative StressStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927339
- Sponsor's protocol ID
- code R.18.04.137
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03927339
- Acronym / sponsor ID
- code R.18.04.137
- Conditions
- Knee Osteoarthriis and Oxidative Stress
- Keywords
- Osteoarthritis- Obesity- single aerobic exercise session
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 29 Jun 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 25 Apr 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.
Background: Obesity and degenerative joint disease are typically concomitant . Each are in the course of aerobic focus and excited inflammatory response. Exercise is taken into account a considerable treatment in rehabilitation of each conditions. nevertheless most of literature reported the good thing about regular exercise, whereas there's dearth regarding the consequence of base hit low to centrist usage session .
Objective:Hence, this report aimed to analyze the attainable effects of a single bout of moderate excercise in obese patients with KOA.
Methods:Thirty four rotund OA untrained semantic role and thirty age and sex matched healthy controls were registered during this sketch . OA patients were allotted to single session of low to moderate exercise on treadmill whereas controls remained unexercised. Perceived pain, GR activity, IL-6 , CRP, fasting blood glucose and lipid profile were assessed at baseline , once exercise and 24h after. Meanwhile, WOMAC score determined at baseline and once 24h.
Detailed description
Study population:
This is an observational study a cohort of sedentary Egyptian patients included thirty four obese patients role diagnosed with primary human knee joint OA according to the criteria of the American College of Rheumatology (ACR)( 8).were selected from those attending the outpatient clinics of Rheumatology and Rehabilitation Department , Mansoura University (28 females and 6 males; mean age, 46.94 ± 10.84 years; trunk mass index, 40.91 ± 10.09 kg/m2). In addition, 30 healthy volunteers with no clinical and radiological evidence of OA(22 females and8 males; mean age,50.7 ±10.5 ; BMI 24.3±1.3)participated in the discipline .
Inclusion criteria: knee OA with obesity; sedentary with no previous education ; ability to understand and follow commands; and ability to walk independently.
Exclusion criteria: Medical conditions contraindicating moderate aerobic exercising (as determined through prescreening questions, i.e., cardiac or coronary artery disease as ischemic cardiomyopathy , chronic lung disease, asthma, uncontrolled hypertension), inability to exercise via treadmill(i.e. no neuromuscular or lower extremity conditions or any other medical contraindication that could prevent them from floor walking as upset affecting movement of the pelvic arch or pace , story of previous hip or knee operating room ,periarticular fractures, or lower limb injuries).History of recent reefer transmission or acute joint lighting .History of recent joint injection (steroid, hyaluronic acid , etc.) within 6 calendar week of study. Ingestion of antioxidant supplementation and the use of psychotropic agents.
Participants underwent bilateral AP standing x ray to verify the presence and degree of human knee OA. X-rays were marked exploitation the Kellgren and Lawrence (K/L) scale for knee OA severity(9).Subjects with picture taking knee OA of KL grade ≥2 in a minimum of one knee were listed. The grading of the worst affected knee in every patient was used for knowledge analysis.
Physical examinations including age and body mass index (BMI) were obtained at the same visits at which radiographs were obtained. Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores of the OA patients were collected (10).
Treadmill Training Protocol
Each eligible participant in the patients group was then prospectively assigned to undergo exercise session of full-body-free weight treadmill training. Once the participants were prepped, they performed stretching for 5 min and slow walking for 3 min as a warm-up exercise before starting the training. Stretch was carried out similarly to all the subjects to quadriceps femoris and the hamstring. In the warm-up time period , it was enforced for 3 min at the speed of1 km/h. Then patients began the walking trials and walked at 1 to 1.34 m/s on an electric car treadmill (JACO fitness: JACO-212C).
Exercise intensity
For the purpose of this study, Metabolic Equivalents (METs) and Rate of Perceived Exertion (RPE) were used as guidelines to determine exercise intensity. Moderate aerobic exercise has been objectively defined as activity that generates energy expenditure of 3.0 to 6.0 (METs) (11).
To determine the intensity, time and frequency of exercise, it was set at low to moderate, that is between 40% and 60% of the maximum heart rate, from 12 to 14 rating of RPE. In addition, each subject was shown the 15 point Borg Rating of Perceived Exertion scale and instructed in its use. The RPE scale was mounted on the wall in front of the treadmill and easily visible to the subjects. Exercise instructions and measurements of associated Metabolic Equivalents (METs) were determined based upon previous studies which determined that walking on a level surface at 3.0 MPH equates to 3.3 METs and walking at 4.5 MPH generates 6.3 METs(12).
Participants walked at a pace of 2.5 to 3.0 MPH on a treadmill with zero incline for 30 min and they were instructed to walk at a pace that neither caused pain nor increased symptoms (13).
To minimize pain that may occur due to treadmill exercise, 5 min rest were allowed after 15 min of exercise. In the control group, the subjects remained at rest.
The present study was conducted in agreement with the guidelines of the Declaration of Helsinki. Written informed consent was received from every patient and healthy subject before participating in the study. This study was approved by the Institutional Research Board of the Faculty of Medicine, Mansoura University code R.18.04.137
Laboratory assays:
Blood samples were drawn before and once exercise (within 0.5 h once exercise,and at 24 h). All organic chemistry measurements were performed on frozen plasma samples obtained by activity of freshly drawn blood (3000 × g for 20minutes at 4∘C) and consequent storage at -70∘C. Blood macromolecule profiles, together with total cholesterol (TC), HDL cholesterol (HDL-C), calculated LDL cholesterol(LDL-C), and triglycerides (TG) concentrations were determined by protein assays., further as abstinence blood sugar level.
IL-6, CRP Serum concentrations of IL-6 were determined using sandwich high sensitivity ELISA kit for quantitative detection of human IL-6 according to manufacturer's protocol (Boster Immunoleader by Boster Biological Technology Co. Inc.). Detection of serum CRP was performed by Solid Phase Sandwich ELISA according to manufacturer's instructions (Quantikine Human CRP Immunoassay, R\&D systems)
Glutathione reductase assay:
Spectrophotometric determination of GR activity in the serum was measured as described by Calberg and Mannervic (14) using commercially available Glutathione Reductase Assay Kit(Sigma chemical company, St Louis, Missouri, USA). Glutathione reductase catalyzes the reduction of GSSG by oxidizing NADPH to NADP+. The decrease in absorbance was measured at 340.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre and post excercise group | – | Diagnostic Test: pre and post excercise group |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- a cohort of egyptian patients suffering from obesity and knee osteoarthritis
Key inclusion criteria (1 listed)
- : knee OA with obesity; sedentary with no previous education ; ability to understand and follow commands; and ability to walk independently.
Key exclusion criteria (1 listed)
- Medical conditions contraindicating moderate aerobic exercising (as determined through prescreening questions, i.e., cardiac or coronary artery disease as ischemic cardiomyopathy , chronic lung disease, asthma, uncontrolled hypertension), inability to exercise via treadmill(i.e. no neuromuscular or lower extremity conditions or any other medical contraindication that could prevent them from floor walking as upset affecting movement of the pelvic arch or pace , story of previous hip or knee operating room ,periarticular fractures, or lower limb injuries).History of recent reefer transmission or acute joint lighting .History of recent joint injection (steroid, hyaluronic acid , etc.) within 6 calendar week of study. Ingestion of antioxidant supplementation and the use of psychotropic agents.
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 |
|---|---|---|
| pre and post excercise groupTreadmill Training Protocol Each eligible participant in the patients group was then prospectively assigned to undergo exercise session of full-body-free weight treadmill training. Once the participants were prepped, they performed stretching for 5 min and slow walking for 3 min as a warm-up exercise before starting the training. Stretch was carried out similarly to all the subjects to quadriceps femoris and the hamstring. In the warm-up time period , it was enforced for 3 min at the speed of1 km/h. Then patients began the walking trials and walked at 1 to 1.34 m/s on an electric car treadmill (JACO fitness: JACO-212C). | Diagnostic test | pre and post excercise group |
Primary outcome
change in degree of pain from base line
Time frame: assessed immediately before excercise, 10 minutes after excercise and 24 hours after excercise
1-Pain Visual Analogue Scale: The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain(1
CHange in function from base line
Time frame: Assessed before excercise immediately,10 minutes after, excercise,24 hours after excercise
Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores of the OA patients were collected (10). Scores from the Western Ontario and Mc-Master University (WOMAC) OA index were used to assess pain, stiffness and function in OA patients [11]. Total WOMAC is the sum of 3 subscales scores. High WOMAC score indicates more pain and stiffness and severe functional limitation.
4 secondary outcomes
CHANGE INserum IL6 FROM BASE LINE,
Time frame: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise
change in serum C REACTIVE PROTEIN from base line
Time frame: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise
change inSERUM LIPID PROFILE from base line
Time frame: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise
change in serum Glutathione reductase assay: from base line
Time frame: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthriis and Oxidative Stress, run by Mansoura University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in degree of pain from base line (time frame: assessed immediately before excercise, 10 minutes after excercise and 24 hours after excercise). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2020.