Older AdultsNCT05138497
HILIT on the Physical, Functional, Cognitive and Psychological Condition of Older Adults
A study testing HILIT in people with Older Adults, run by University of Jaén at 1 site in Colombia.
Trial summary
To analyze the effects of a program based on high intensity interval training and low impact on the state of health and the physical, functional, cognitive and psychological condition in Colombian people over 65 years of age. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults
- What is being tested?
- HILIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteColombia
- Study dates
- 11 Jan 2022to 12 Apr 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women over 65 years of age, who voluntarily agree to participate in the study.
- Be able to understand the instructions and exercise protocols for this project.
Who cannot join
- Contraindications to the performance of physical tests or exercise.
- People with a diagnosis of pathologies such as cancer, pulmonary hypertension and kidney failure, a population with a diagnosis of heart failure or orphan diseases, a population with a psychiatric diagnosis and / or management, or with neurological or cognitive alterations.
- People with a diagnosis of Human Immunodeficiency Virus (HIV / AIDS) infection or disease.
- Do not agree to participate in the study or those who at the time of entry to the program have denied the endorsement of the use of their data for research in informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Program Based on High Intensity Interval Training and Low Impact on Physical, Functional, Cognitive and Psychological Condition in Colombians Older Than 65 Years.
To analyze the effects of a program based on high intensity interval training and low impact on the state of health and the physical, functional, cognitive and psychological condition in Colombian people over 65 years of age.
Read the detailed description
This research corresponds to an experimental study, a double-blind randomized controlled clinical trial, where a total of 92 men and women 65 years old will be evaluated, distributed in two groups: the experimental group will receive a Beat Fit-type HILIT program (n = 46) 12 weeks; and the control group (n = 46) that will only receive general recommendations on the benefits of physical exercise. The variables will be measured for both groups with the same validated tools and the same researcher to avoid information biases and differential incorrect classification. The evaluations will be carried out at the beginning of the intervention and immediately after the end of this period, and the results will be recorded in a data record that will later be unified in an Excel database registering a code for each participant to maintain condition of privacy, but at the same time allow the required comparability.
For the independent variables, the sociodemographic characteristics, clinical history and the socio-family assessment scale will be addressed; The result variables are divided by areas: those focused on health status will measure the relative risk of death due to Comorbidity from the Charlson Index, Health-related Quality of Life [HRQoL] with the SF36 questionnaire, the Questionnaire To determine sarcopenia, it will be the SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls) and the Fried fragility phenotype will be applied. For the physical condition variables, the ECFA battery will be used; for the execution of sequential locomotive tasks it will be measured with the "8-foot up-and-go test"; gait and balance from the Tinetti Scale, Gait Speed with the 6-minute Test; and postural stability and balance from the Berg Scale. For the functional variables, the Katz Index (activities of daily living), the Lawton \& Brody Index of the Vice-Rector's Office for Undergraduate, Postgraduate and Permanent Training (instrumental activities of daily life) and the Siu and Reuben physical scale ( Advanced activities of daily living). For the Cognitive Variable, the Minimental Status Examination (MMSE) and for the psychological variables, Yesavage will be applied for depression, the Pittsburgh Index for sleep quality and fear of falling with the international scale FES-I (Falls Efficacy Scale-International). All variables will have pre and post intervention measurements. As a result, a dance-based HILIT training program (Beat Fit) is expected to improve the health, physical, functional, cognitive and psychological condition of Colombian adults over 65 years of age, thus contributing to the comprehensive approach of this population. Once the intervention is completed, the final evaluation will be carried out and, from the comparative process, define if there are significant differences with respect to the results obtained initially.
- Conditions
- Older Adults
- Being tested
- HILIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HILITOther
A total of 92 men and women 65 years old, distributed in an experimental group that will receive a 12-week of HILIT program (n = 46); and a control group (n = 46) that will only receive general recommendations on the benefits of physical exercise. The variables will be measured for both groups with the same validated tools and the same researcher to avoid information biases and differential incorrect classification.
| Study group | Role | What they receive |
|---|---|---|
| HILIT group | Experimental | An experimental group (EG) that after an initial evaluation and with their consent, will be subjected to a directed physical training program for 12 weeks with 3 weekly sessions (Monday, Wednesday and Friday), with a duration of 50 min per session. The exercises to be carried out will be divided into three different phases: warm-up during the first 10 minutes; the main part with a duration of 30 minutes (where each exercise should be performed for 20 to 30 seconds as intense or fast as possible without generating joint impact, and then take a break for 10 to 15 seconds, before repeating it); and the return to calm, based mainly on stretching exercises with a total duration of 10 minutes. Receives: Other: HILIT |
| Control group | No intervention | A control group (CG) that will not undergo treatment, which will be evaluated in the pre and post phase of the study. The participants assigned to this group will receive general advice on the positive effects of the regular practice of physical activity, and they will be given the guide of recommendations for the promotion of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Charlson index. Absence of comorbidity is considered when the score is 0-1 points, low comorbidity 2 points and high cormobility in scores equal to or greater than 3 points.
Relative risk of death due to comorbidity.
Measured: Up to twelve weeks
The Short Form-36 Health Survey (SF-36)
Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.
Measured: Up to twelve weeks
Short Physical Performance Battery (SPPB)
Short test battery, widely used in geriatrics, consists of evaluating the patient from 3 points of view: on the one hand, the patient's balance is measured, counting if he is able to maintain balance for at least 10 seconds with his feet together, in semi-tandem and tandem, counting the speed of the gait, measuring the time it takes to walk 4m, and the strength and resistance of the lower body, counting the time it takes to perform 5 squats (STS5).
Measured: Up to twelve weeks
The Berg Balance Scale (BBS)
Used to assess a person's static and dynamic balance skills.
Measured: Up to twelve weeks
KATZ INDEX
Is a widely used tool to assess the level of independency in older adults. It is scored considering the items grouped to obtain degrees A, B, C, etc., of independence. It is observed that 0 points are equal to grade A, 1 point to grade B, 2 points to grade C, 3 points to grade D, and so on.
In a conventional way, the following classification can be assumed:
- Grades A-B or 0 - 1 points = absence of disability or mild disability.
- Grades C-D or 2 - 3 points = moderate disability.
- Grades E-G or 4 - 6 points = severe disability.
Measured: Up to twelve weeks
The Lawton & Brody scale
Evaluates independence and functionality in instrumental activities of daily life) such as shopping, cooking, cleaning, washing, finances, medication, transportation and use of the telephone; and considers instrumental disability the inability to perform one or more activities. Each area is scored according to the description that best corresponds to the subject. Therefore, each area scores a maximum of 1 point and a minimum of 0 points. The maximum dependence would be marked by obtaining 0 points, while a sum of 8 points would express total independence.
Measured: Up to twelve weeks
The physical scale of advanced life activities Reuben's day.
Evaluates the degree of integration in the community, social relationships and is sensitive to the functional assessment of individuals in the community
Measured: Up to twelve weeks
Mini-Mental State Examination (MMSE)
The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
Measured: Up to twelve weeks
MoCA (Montreal Cognitive Assessment)
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
Measured: Up to twelve weeks
The Yesavage Geriatric Depression Scale
Questionnaire used to screen for depression in older people. Scores from 00 to 05 indicate Normal screening, 06 to 10 Moderate Depression screening, and 11 to 15 Severe Depression screening.
Measured: Up to twelve weeks
PSQI (Pittsburgh Sleep Quality Index)
A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.
Measured: Up to twelve weeks
FES-I (Falls Efficacy Scale-International)
Questionnaire that evaluates the fear of falling. After adding the total score, values of 16-19 indicate little fear; between 20-27, intermediate fear, and from 28-64, intense fear, representing a greater risk of falls the higher the total score.
Measured: Up to twelve weeks
Handgrip Strength
Dynamometer will be employed to assess hand grip stregth.
Measured: Up to twelve weeks
Tinetti scale
It is used to determine early the risk of falling in an elderly person during the year following its application. The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.
Measured: Up to twelve weeks
TUG test (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function.
Measured: Up to twelve weeks
Secondary outcomes (11)
SARC-F
Screening to assess the risk of sarcopenia. It generates a total score of 0-10 points, of which the range of 0-3 is recorded without sarcopenia while 4-10 suggest sarcopenia.
Measured: Up to twelve weeks
Frailty phenotype
Five original characteristics are evaluated: involuntary weight loss, self-reported exhaustion, slow gait speed, weakness, and low physical activity.
Measured: Up to twelve weeks
Waist circumference
Is used to assess central fat distribution and degree of abdominal obesity
Measured: Up to twelve weeks
Hip circumference
It is measured at the level of the maximum prominence of the buttocks.
Measured: Up to twelve weeks
Waist-to-hip ratio
Is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement
Measured: Up to twelve weeks
Mini Nutritional Assessment - Short Form (MNA®-SF)
It is a simple and quick method to identify elderly people who are at risk of malnutrition or undernourished.
Measured: Up to twelve weeks
The 6-minute walk test (PC6M)
Assesses in an integrated way the response of the respiratory, cardiovascular, metabolic, skeletal muscle and neurosensory systems to the stress imposed by exercise.
Measured: Up to twelve weeks
The 8 foot up & go test
Assesses agility and dynamic balance.
Measured: Up to twelve weeks
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Measured: Up to twelve weeks
Body Weight
Is the sum of Body Fat and Fat Free Mass.
Measured: Up to twelve weeks
Height
It measures a person's height, measured from the sole of the foot to the top of the head.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start11 Jan 2022
- Primary completion18 Jan 2022
- Study completion12 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138497
- Sponsor's protocol ID
- -University of Jaén
- Status last verified
- Feb 2023
- First submitted
- 22 Oct 2021
- Last updated
- 16 Feb 2023
- 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Program Based on High Intensity Interval Training and Low Impact on Physical, Functional, Cognitive and Psychological Condition in Colombians Older Than 65 Years.
- ClinicalTrials.gov ID
- NCT05138497
- Acronym / sponsor ID
- -University of Jaén
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 1 Dec 2021 (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.
To analyze the effects of a program based on high intensity interval training and low impact on the state of health and the physical, functional, cognitive and psychological condition in Colombian people over 65 years of age.
Detailed description
This research corresponds to an experimental study, a double-blind randomized controlled clinical trial, where a total of 92 men and women 65 years old will be evaluated, distributed in two groups: the experimental group will receive a Beat Fit-type HILIT program (n = 46) 12 weeks; and the control group (n = 46) that will only receive general recommendations on the benefits of physical exercise. The variables will be measured for both groups with the same validated tools and the same researcher to avoid information biases and differential incorrect classification. The evaluations will be carried out at the beginning of the intervention and immediately after the end of this period, and the results will be recorded in a data record that will later be unified in an Excel database registering a code for each participant to maintain condition of privacy, but at the same time allow the required comparability.
For the independent variables, the sociodemographic characteristics, clinical history and the socio-family assessment scale will be addressed; The result variables are divided by areas: those focused on health status will measure the relative risk of death due to Comorbidity from the Charlson Index, Health-related Quality of Life [HRQoL] with the SF36 questionnaire, the Questionnaire To determine sarcopenia, it will be the SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls) and the Fried fragility phenotype will be applied. For the physical condition variables, the ECFA battery will be used; for the execution of sequential locomotive tasks it will be measured with the "8-foot up-and-go test"; gait and balance from the Tinetti Scale, Gait Speed with the 6-minute Test; and postural stability and balance from the Berg Scale. For the functional variables, the Katz Index (activities of daily living), the Lawton \& Brody Index of the Vice-Rector's Office for Undergraduate, Postgraduate and Permanent Training (instrumental activities of daily life) and the Siu and Reuben physical scale ( Advanced activities of daily living). For the Cognitive Variable, the Minimental Status Examination (MMSE) and for the psychological variables, Yesavage will be applied for depression, the Pittsburgh Index for sleep quality and fear of falling with the international scale FES-I (Falls Efficacy Scale-International). All variables will have pre and post intervention measurements. As a result, a dance-based HILIT training program (Beat Fit) is expected to improve the health, physical, functional, cognitive and psychological condition of Colombian adults over 65 years of age, thus contributing to the comprehensive approach of this population. Once the intervention is completed, the final evaluation will be carried out and, from the comparative process, define if there are significant differences with respect to the results obtained initially.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HILIT group | Experimental | Other: HILITAn experimental group (EG) that after an initial evaluation and with their consent, will be subjected to a directed physical training program for 12 weeks with 3 weekly sessions (Monday, Wednesday and Friday), with a duration of 50 min per session. The exercises to be carried out will be divided into three different phases: warm-up during the first 10 minutes; the main part with a duration of 30 minutes (where each exercise should be performed for 20 to 30 seconds as intense or fast as possible without generating joint impact, and then take a break for 10 to 15 seconds, before repeating it); and the return to calm, based mainly on stretching exercises with a total duration of 10 minutes. |
| Control group | No intervention | –A control group (CG) that will not undergo treatment, which will be evaluated in the pre and post phase of the study. The participants assigned to this group will receive general advice on the positive effects of the regular practice of physical activity, and they will be given the guide of recommendations for the promotion of physical activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women over 65 years of age, who voluntarily agree to participate in the study.
- Be able to understand the instructions and exercise protocols for this project.
Key exclusion criteria (4 listed)
- Contraindications to the performance of physical tests or exercise.
- People with a diagnosis of pathologies such as cancer, pulmonary hypertension and kidney failure, a population with a diagnosis of heart failure or orphan diseases, a population with a psychiatric diagnosis and / or management, or with neurological or cognitive alterations.
- People with a diagnosis of Human Immunodeficiency Virus (HIV / AIDS) infection or disease.
- Do not agree to participate in the study or those who at the time of entry to the program have denied the endorsement of the use of their data for research in informed consent.
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 |
|---|---|---|
| HILITA total of 92 men and women 65 years old, distributed in an experimental group that will receive a 12-week of HILIT program (n = 46); and a control group (n = 46) that will only receive general recommendations on the benefits of physical exercise. The variables will be measured for both groups with the same validated tools and the same researcher to avoid information biases and differential incorrect classification. | Other | HILIT group |
Primary outcome
Charlson index. Absence of comorbidity is considered when the score is 0-1 points, low comorbidity 2 points and high cormobility in scores equal to or greater than 3 points.
Time frame: Up to twelve weeks
Relative risk of death due to comorbidity.
The Short Form-36 Health Survey (SF-36)
Time frame: Up to twelve weeks
Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.
Short Physical Performance Battery (SPPB)
Time frame: Up to twelve weeks
Short test battery, widely used in geriatrics, consists of evaluating the patient from 3 points of view: on the one hand, the patient's balance is measured, counting if he is able to maintain balance for at least 10 seconds with his feet together, in semi-tandem and tandem, counting the speed of the gait, measuring the time it takes to walk 4m, and the strength and resistance of the lower body, counting the time it takes to perform 5 squats (STS5).
The Berg Balance Scale (BBS)
Time frame: Up to twelve weeks
Used to assess a person's static and dynamic balance skills.
KATZ INDEX
Time frame: Up to twelve weeks
Is a widely used tool to assess the level of independency in older adults. It is scored considering the items grouped to obtain degrees A, B, C, etc., of independence. It is observed that 0 points are equal to grade A, 1 point to grade B, 2 points to grade C, 3 points to grade D, and so on. In a conventional way, the following classification can be assumed: * Grades A-B or 0 - 1 points = absence of disability or mild disability. * Grades C-D or 2 - 3 points = moderate disability. * Grades E-G or 4 - 6 points = severe disability.
The Lawton & Brody scale
Time frame: Up to twelve weeks
Evaluates independence and functionality in instrumental activities of daily life) such as shopping, cooking, cleaning, washing, finances, medication, transportation and use of the telephone; and considers instrumental disability the inability to perform one or more activities. Each area is scored according to the description that best corresponds to the subject. Therefore, each area scores a maximum of 1 point and a minimum of 0 points. The maximum dependence would be marked by obtaining 0 points, while a sum of 8 points would express total independence.
The physical scale of advanced life activities Reuben's day.
Time frame: Up to twelve weeks
Evaluates the degree of integration in the community, social relationships and is sensitive to the functional assessment of individuals in the community
Mini-Mental State Examination (MMSE)
Time frame: Up to twelve weeks
The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
MoCA (Montreal Cognitive Assessment)
Time frame: Up to twelve weeks
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
The Yesavage Geriatric Depression Scale
Time frame: Up to twelve weeks
Questionnaire used to screen for depression in older people. Scores from 00 to 05 indicate Normal screening, 06 to 10 Moderate Depression screening, and 11 to 15 Severe Depression screening.
PSQI (Pittsburgh Sleep Quality Index)
Time frame: Up to twelve weeks
A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.
FES-I (Falls Efficacy Scale-International)
Time frame: Up to twelve weeks
Questionnaire that evaluates the fear of falling. After adding the total score, values of 16-19 indicate little fear; between 20-27, intermediate fear, and from 28-64, intense fear, representing a greater risk of falls the higher the total score.
Handgrip Strength
Time frame: Up to twelve weeks
Dynamometer will be employed to assess hand grip stregth.
Tinetti scale
Time frame: Up to twelve weeks
It is used to determine early the risk of falling in an elderly person during the year following its application. The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.
TUG test (Timed Up and Go test)
Time frame: Up to twelve weeks
Is a simple test used to assess a person's mobility and physical function.
11 secondary outcomes
SARC-F
Time frame: Up to twelve weeks
Frailty phenotype
Time frame: Up to twelve weeks
Waist circumference
Time frame: Up to twelve weeks
Hip circumference
Time frame: Up to twelve weeks
Waist-to-hip ratio
Time frame: Up to twelve weeks
Mini Nutritional Assessment - Short Form (MNA®-SF)
Time frame: Up to twelve weeks
The 6-minute walk test (PC6M)
Time frame: Up to twelve weeks
The 8 foot up & go test
Time frame: Up to twelve weeks
BMI (Body Mass Index)
Time frame: Up to twelve weeks
Body Weight
Time frame: Up to twelve weeks
Height
Time frame: Up to twelve weeks
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 16 Feb 2023.
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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?
A study testing HILIT in people with Older Adults, run by University of Jaén at 1 site in Colombia.
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 2 inclusion and 4 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 16 Feb 2023. 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 Colombia. 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?
Charlson index. Absence of comorbidity is considered when the score is 0-1 points, low comorbidity 2 points and high cormobility in scores equal to or greater than 3 points. (time frame: Up to twelve weeks). The study lists 15 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 16 Feb 2023.