Metabolic SyndromeNCT05504629
Interindividual Postexercise Hypotension Response in Morbid Obesity
A study testing Concurrent training order 1 and RT+ET in people with Metabolic Syndrome and Morbid Obesity, run by Universidad Nacional Andres Bello at 1 site in Chile.
Trial summary
A quasi-experimental study developed in sedentary morbidly obese men and women (age 43.6±11.3 y; body mass index [BMI] ≥40 kg/m2) were assigned to a CT group of ET plus RT (ET+RT; n=19; BMI 47.8±16.7) or RT plus ET order group (RT+ET; n=17; BMI 43.0±8.0). Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Metabolic Syndrome, Morbid Obesity
- What is being tested?
- Concurrent training order 1 and RT+ET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 5 Mar 2019to 5 Oct 2019
- Phase
- Interventional
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age >18 and <60 years
- women or men
- medical authorization for physical tests
- body mass index (BMI) ≥40 kg/m2, or between 35 and 40 kg/m2 but with previously diagnosed of morbid obesity and candidate for bariatric surgery
Who cannot join
- physical limitations to performing the physical test (e.g., restrictive injuries of the musculoskeletal system)
- exercise-related dyspnoea or respiratory alterations
- chronic heart disease diagnosed during the time of morbid obesity diagnosed and the starting of the exercise intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing The Interindividual Postexercise Hypotension Response For Two Order of Concurrent Training In Patients With Morbid Obesity
A quasi-experimental study developed in sedentary morbidly obese men and women (age 43.6±11.3 y; body mass index [BMI] ≥40 kg/m2) were assigned to a CT group of ET plus RT (ET+RT; n=19; BMI 47.8±16.7) or RT plus ET order group (RT+ET; n=17; BMI 43.0±8.0). Subjects of both groups received eight exercise sessions over four weeks. Systolic (SBP), diastolic (DBP), mean arterial pressure [MAP], heart rate at rest [HR], and pulse pressure [PP] measurements before and after 10 minutes postexercise. Secondary outcomes were other anthropometric, body composition, metabolic, and physical condition parameters. Using the ∆SBP reduction, and quartile categorization (Q) in 'high' (Rs: quartile 4), 'moderate' (MRs: quartile 3), 'low' (LRs: quartile 2), and 'nonresponders' (NRs: quartile 1) were reported.
Read the detailed description
Independent of the order (i.e., ET+RT, or RT+ET), each CT session had two sections; RT and ET, which were applied two days per week, during 8 sessions (4 weeks), and where the blood pressure changes were measured only in four opportunities (i.e., once a week in sessions 2, 4, 6, and 8). Thus, the CT included in each session 3 stages; a) callisthenics exercises, b) main exercise (ET+RT or RT+ET), and c) cool down exercises.
Before the starting, the participants were involved in the maximum strength capacity estimated using a submaximal test based on the Brzycki's equation: weight [1.0278-(0.0278*repetitions)] that does not change based on the sex, age of the population, or the exercise modality that is performed (Mayhew et al., 2004). After this procedure, there were applied 4 familiarization sessions that consisted in; session 1: 'knowledge of all measurements', 'knowledge of exercise-machine manipulation', and 'instructions during the exercise program', session 2: 'exercising during cycling', 'weights, and metal bars', session 3: 'applying a few of exercises of RT in 2 to 3 sets of exercises, to know the configuration of each exercise (i.e., ET and RT regimes itself), and session 4: 'applying the 50 to 70% of their CT program' corresponding to a normal session compound. In the 'calisthenic stage', each subject developed 10 minute warm-up with continuous walking, joint mobility and flexibility exercises. In the 'main part' of the session, and independent of the CT order group (ET+RT or RT+ET), the ET section consisted of continuous cycling using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile) for 20 minutes. The intensity of the ET exercise was regulated through the previously used modified Borg scale from 1 to 10 rating of perceived exertion (Gillen et al., 2013) and the participants worked at a level between 5 to 7 points (i.e., moderate-intensity), considering the original 6 to 20 points scale (Borg, 1998), being the subjects regularly controlled to not exceed this intensity restriction. On the other hand, the RT section included 8 to 12 muscle strength exercises of circuit training with the following different muscle groups: (1) forearm, (2) knee flexors and extensors, (3) trunk, (4) chest, (5) shoulder elevators, (6) horizontal shoulder flexors, (7) extensors, and finally (8) plantar flexors. These exercises were performed in one set in a continuous concentric/eccentric voluntary contraction as possible for 60 seconds, followed by 60 to 90 seconds of passive recovery, where each participant was changed to another exercise. The RT section was of 25 minutes in duration time.
- Conditions
- Metabolic Syndrome, Morbid Obesity
- Being tested
- Concurrent training order 1, RT+ET
- Medical subject headings
- Metabolic Syndrome, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent training order 1Behavioural
Also called Exercise training
atag
RT+ETBehavioural
Also called Concurrent training order 2
aetaer
| Study group | Role | What they receive |
|---|---|---|
| Endurance Training (ET) plus Resistance Training (RT) | Experimental | Concurrent training of Endurance Training plus Resistance Training order. Receives: Behavioral: RT+ET |
| Resistance Training (RT) plus Endurance Training (ET) | Active comparator | Concurrent training of Resistance Training plus Endurance Training order. Receives: Behavioral: Concurrent training order 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure measured by a blood pressure cuff
Change from Baseline in systolic blood pressure in the unit of (mmHg)
Measured: From baseline to 10 minutes after exercise training
Diastolic blood pressure measured by a blood pressure cuff
Change from Baseline in diastolic blood pressure in the unit of (mmHg)
Measured: From baseline to 10 minutes after exercise training
Mean arterial pressure measured by a blood pressure cuff
Change from Baseline in mean arterial blood pressure in the unit of (mmHg)
Measured: From baseline to 10 minutes after exercise training
Secondary outcomes (18)
Heart rate at rest measured by a cardiometer watch
Change from Baseline in Heart rate at rest in (beats per minute)
Measured: From baseline to 10 minutes after exercise training
Pulse pressure measured by a blood pressure cuff
Change from Baseline in Pulse pressure in the unit of (mmHg)
Measured: From baseline to 10 minutes after exercise training
Body mass measured by a scale
Change from Baseline in Body mass in (kg)
Measured: From baseline to 10 minutes after exercise training
Body mass index calculated from weight plus height and elevated to square
Change from Baseline in Body mass index in (kg/m2)
Measured: From baseline to 10 minutes after exercise training
Waist circumference measured by a flexible tape
Change from Baseline in Waist circumference in (cm)
Measured: From baseline to 10 minutes after exercise training
Body fat percentage measured by a digital bioimpedanciometer scale
Change from Baseline in Body fat percentage in (%)
Measured: From baseline to 10 minutes after exercise training
Lean mass measured by a digital bioimpedanciometer scale
Change from Baseline in Body fat percentage in (kg)
Measured: From baseline to 10 minutes after exercise training
Skeletal muscle mass measured by a digital bioimpedanciometer scale
Change from Baseline in Skeletal muscle mass in (kg)
Measured: From baseline to 10 minutes after exercise training
Bone mass measured by a digital bioimpedanciometer scale
Change from Baseline in Bone mass in (kg)
Measured: From baseline to 10 minutes after exercise training
Basal metabolic rate measured by a digital bioimpedanciometer scale
Change from Baseline in Basal metabolic rate in (Kcal)
Measured: From baseline to 10 minutes after exercise training
Fasting plasma glucose measured by blood sample in fasting state
Change from Baseline in Fasting plasma glucose in (mg/dL)
Measured: From baseline to 10 minutes after exercise training
Total cholesterol measured by blood sample in fasting state
Change from Baseline in Total cholesterol in (mg/dL)
Measured: From baseline to 10 minutes after exercise training
Low density lipids measured by blood sample in fasting state
Change from Baseline in Low density lipids in (mg/dL)
Measured: From baseline to 10 minutes after exercise training
High density lipids measured by blood sample in fasting state
Change from Baseline in High density lipids in (mg/dL)
Measured: From baseline to 10 minutes after exercise training
Triglycerides measured by blood sample in fasting state
Change from Baseline in Triglycerides in (mg/dL)
Measured: From baseline to 10 minutes after exercise training
Six minutes walking test measured by a walking test into a sport court
Change from Baseline in Six minutes walking test in (m)
Measured: From baseline to 10 minutes after exercise training
Handgrip muscle strength of the non-dominant arm measured by a dynamometer hand equipment
Change from Baseline in Handgrip strength in the non-dominant arm measured by dynamometer at sitting position in (kg)
Measured: From baseline to 10 minutes after exercise training
Handgrip strength Dominant arm measured by a dynamometer hand equipment
Change from Baseline in Handgrip strength in the Dominant arm measured by dynamometer at sitting position in (kg)
Measured: From baseline to 10 minutes after exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start5 Mar 2019
- Primary completion5 Sep 2019
- Study completion5 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Andres Bello
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de La Frontera
- Responsible party
- Principal investigator, Cristian Alvarez, Universidad Nacional Andres Bello
- Investigators
- Pedro Delgado Floody, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504629
- Sponsor's protocol ID
- UNAB-FCR-KINE2022A
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delgado-Floody P, Izquierdo M, Ramirez-Velez R, Caamano-Navarrete F, Moris R, Jerez-Mayorga D, Andrade DC, Alvarez C. Effect of High-Intensity Interval Training on Body Composition, Cardiorespiratory Fitness, Blood Pressure, and Substrate Utilization During Exercise Among Prehypertensive and Hypertensive Patients With Excessive Adiposity. Front Physiol. 2020 Oct 19;11:558910. doi: 10.3389/fphys.2020.558910. eCollection 2020.
PubMed 33192554Delgado-Floody P, Soriano-Maldonado A, Rodriguez-Perez MA, Latorre-Roman PA, Martinez-Salazar C, Vargas CA, Caamano-Navarrete F, Jerez-Mayorga D, Alvarez C. The Effects of Two Different Concurrent Training Configurations on Markers of Metabolic Syndrome and Fitness in Women With Severe/Morbid Obesity: A Randomised Controlled Trial. Front Physiol. 2021 Sep 21;12:694798. doi: 10.3389/fphys.2021.694798. eCollection 2021.
PubMed 34621181Alvarez C, Ramirez-Campillo R, Ramirez-Velez R, Izquierdo M. Effects and prevalence of nonresponders after 12 weeks of high-intensity interval or resistance training in women with insulin resistance: a randomized trial. J Appl Physiol (1985). 2017 Apr 1;122(4):985-996. doi: 10.1152/japplphysiol.01037.2016. Epub 2017 Feb 2.
PubMed 28153946
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing The Interindividual Postexercise Hypotension Response For Two Order of Concurrent Training In Patients With Morbid Obesity
- ClinicalTrials.gov ID
- NCT05504629
- Acronym / sponsor ID
- UNAB-FCR-KINE2022A
- Conditions
- Metabolic Syndrome, Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Nacional Andres BelloUniversity, hospital or other
- Collaborators
- Universidad de La Frontera
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 17 Aug 2022 (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.
A quasi-experimental study developed in sedentary morbidly obese men and women (age 43.6±11.3 y; body mass index [BMI] ≥40 kg/m2) were assigned to a CT group of ET plus RT (ET+RT; n=19; BMI 47.8±16.7) or RT plus ET order group (RT+ET; n=17; BMI 43.0±8.0). Subjects of both groups received eight exercise sessions over four weeks. Systolic (SBP), diastolic (DBP), mean arterial pressure [MAP], heart rate at rest [HR], and pulse pressure [PP] measurements before and after 10 minutes postexercise. Secondary outcomes were other anthropometric, body composition, metabolic, and physical condition parameters. Using the ∆SBP reduction, and quartile categorization (Q) in 'high' (Rs: quartile 4), 'moderate' (MRs: quartile 3), 'low' (LRs: quartile 2), and 'nonresponders' (NRs: quartile 1) were reported.
Detailed description
Independent of the order (i.e., ET+RT, or RT+ET), each CT session had two sections; RT and ET, which were applied two days per week, during 8 sessions (4 weeks), and where the blood pressure changes were measured only in four opportunities (i.e., once a week in sessions 2, 4, 6, and 8). Thus, the CT included in each session 3 stages; a) callisthenics exercises, b) main exercise (ET+RT or RT+ET), and c) cool down exercises.
Before the starting, the participants were involved in the maximum strength capacity estimated using a submaximal test based on the Brzycki's equation: weight [1.0278-(0.0278*repetitions)] that does not change based on the sex, age of the population, or the exercise modality that is performed (Mayhew et al., 2004). After this procedure, there were applied 4 familiarization sessions that consisted in; session 1: 'knowledge of all measurements', 'knowledge of exercise-machine manipulation', and 'instructions during the exercise program', session 2: 'exercising during cycling', 'weights, and metal bars', session 3: 'applying a few of exercises of RT in 2 to 3 sets of exercises, to know the configuration of each exercise (i.e., ET and RT regimes itself), and session 4: 'applying the 50 to 70% of their CT program' corresponding to a normal session compound. In the 'calisthenic stage', each subject developed 10 minute warm-up with continuous walking, joint mobility and flexibility exercises. In the 'main part' of the session, and independent of the CT order group (ET+RT or RT+ET), the ET section consisted of continuous cycling using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile) for 20 minutes. The intensity of the ET exercise was regulated through the previously used modified Borg scale from 1 to 10 rating of perceived exertion (Gillen et al., 2013) and the participants worked at a level between 5 to 7 points (i.e., moderate-intensity), considering the original 6 to 20 points scale (Borg, 1998), being the subjects regularly controlled to not exceed this intensity restriction. On the other hand, the RT section included 8 to 12 muscle strength exercises of circuit training with the following different muscle groups: (1) forearm, (2) knee flexors and extensors, (3) trunk, (4) chest, (5) shoulder elevators, (6) horizontal shoulder flexors, (7) extensors, and finally (8) plantar flexors. These exercises were performed in one set in a continuous concentric/eccentric voluntary contraction as possible for 60 seconds, followed by 60 to 90 seconds of passive recovery, where each participant was changed to another exercise. The RT section was of 25 minutes in duration time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance Training (ET) plus Resistance Training (RT) | Experimental | Behavioral: RT+ETConcurrent training of Endurance Training plus Resistance Training order. |
| Resistance Training (RT) plus Endurance Training (ET) | Active comparator | Behavioral: Concurrent training order 1Concurrent training of Resistance Training plus Endurance Training order. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age >18 and <60 years
- women or men
- medical authorization for physical tests
- body mass index (BMI) ≥40 kg/m2, or between 35 and 40 kg/m2 but with previously diagnosed of morbid obesity and candidate for bariatric surgery
Key exclusion criteria (3 listed)
- physical limitations to performing the physical test (e.g., restrictive injuries of the musculoskeletal system)
- exercise-related dyspnoea or respiratory alterations
- chronic heart disease diagnosed during the time of morbid obesity diagnosed and the starting of the exercise intervention
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 |
|---|---|---|
| Concurrent training order 1Also: Exercise trainingatag | Behavioural | Resistance Training (RT) plus Endurance Training (ET) |
| RT+ETAlso: Concurrent training order 2aetaer | Behavioural | Endurance Training (ET) plus Resistance Training (RT) |
Primary outcome
Systolic blood pressure measured by a blood pressure cuff
Time frame: From baseline to 10 minutes after exercise training
Change from Baseline in systolic blood pressure in the unit of (mmHg)
Diastolic blood pressure measured by a blood pressure cuff
Time frame: From baseline to 10 minutes after exercise training
Change from Baseline in diastolic blood pressure in the unit of (mmHg)
Mean arterial pressure measured by a blood pressure cuff
Time frame: From baseline to 10 minutes after exercise training
Change from Baseline in mean arterial blood pressure in the unit of (mmHg)
18 secondary outcomes
Heart rate at rest measured by a cardiometer watch
Time frame: From baseline to 10 minutes after exercise training
Pulse pressure measured by a blood pressure cuff
Time frame: From baseline to 10 minutes after exercise training
Body mass measured by a scale
Time frame: From baseline to 10 minutes after exercise training
Body mass index calculated from weight plus height and elevated to square
Time frame: From baseline to 10 minutes after exercise training
Waist circumference measured by a flexible tape
Time frame: From baseline to 10 minutes after exercise training
Body fat percentage measured by a digital bioimpedanciometer scale
Time frame: From baseline to 10 minutes after exercise training
Lean mass measured by a digital bioimpedanciometer scale
Time frame: From baseline to 10 minutes after exercise training
Skeletal muscle mass measured by a digital bioimpedanciometer scale
Time frame: From baseline to 10 minutes after exercise training
Bone mass measured by a digital bioimpedanciometer scale
Time frame: From baseline to 10 minutes after exercise training
Basal metabolic rate measured by a digital bioimpedanciometer scale
Time frame: From baseline to 10 minutes after exercise training
Fasting plasma glucose measured by blood sample in fasting state
Time frame: From baseline to 10 minutes after exercise training
Total cholesterol measured by blood sample in fasting state
Time frame: From baseline to 10 minutes after exercise training
Low density lipids measured by blood sample in fasting state
Time frame: From baseline to 10 minutes after exercise training
High density lipids measured by blood sample in fasting state
Time frame: From baseline to 10 minutes after exercise training
Triglycerides measured by blood sample in fasting state
Time frame: From baseline to 10 minutes after exercise training
Six minutes walking test measured by a walking test into a sport court
Time frame: From baseline to 10 minutes after exercise training
Handgrip muscle strength of the non-dominant arm measured by a dynamometer hand equipment
Time frame: From baseline to 10 minutes after exercise training
Handgrip strength Dominant arm measured by a dynamometer hand equipment
Time frame: From baseline to 10 minutes after exercise training
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 24 Aug 2022.
- Results publication: PubMed 33192554Delgado-Floody P, Izquierdo M, Ramirez-Velez R, Caamano-Navarrete F, Moris R, Jerez-Mayorga D, Andrade DC, Alvarez C. Effect of High-Intensity Interval Training on Body Composition, Cardiorespiratory Fitness, Blood Pressure, and Substrate Utilization During Exercise Among Prehypertensive and Hypertensive Patients With Excessive Adiposity. Front Physiol. 2020 Oct 19;11:558910. doi: 10.3389/fphys.2020.558910. eCollection 2020.
- Results publication: PubMed 34621181Delgado-Floody P, Soriano-Maldonado A, Rodriguez-Perez MA, Latorre-Roman PA, Martinez-Salazar C, Vargas CA, Caamano-Navarrete F, Jerez-Mayorga D, Alvarez C. The Effects of Two Different Concurrent Training Configurations on Markers of Metabolic Syndrome and Fitness in Women With Severe/Morbid Obesity: A Randomised Controlled Trial. Front Physiol. 2021 Sep 21;12:694798. doi: 10.3389/fphys.2021.694798. eCollection 2021.
- Results publication: PubMed 28153946Alvarez C, Ramirez-Campillo R, Ramirez-Velez R, Izquierdo M. Effects and prevalence of nonresponders after 12 weeks of high-intensity interval or resistance training in women with insulin resistance: a randomized trial. J Appl Physiol (1985). 2017 Apr 1;122(4):985-996. doi: 10.1152/japplphysiol.01037.2016. Epub 2017 Feb 2.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 1
Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi Anemia
Fanconi Anemia, Head and Neck Cancer
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.
Pedro Delgado Floody, PhD principal investigator
Universidad de La Frontera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent training order 1 and RT+ET in people with Metabolic Syndrome and Morbid Obesity, run by Universidad Nacional Andres Bello at 1 site in Chile.
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 4 inclusion and 3 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 24 Aug 2022. 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 Chile. 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?
Systolic blood pressure measured by a blood pressure cuff (time frame: From baseline to 10 minutes after exercise training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504629, which also lists 3 linked publications.
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 24 Aug 2022.