Community-dwelling Older AdultsNCT04189458
Multimodal Exercise Effect on Brain Dynamics, Cognitive Functioning and Physical Fitness
A study testing Multimodal exercise program in people with Community-dwelling Older Adults, run by University of Évora at 1 site in Portugal.
Trial summary
The aim of present study is to analyze the effect of a multimodal exercise program on brain dynamics, cognitive functioning and physical fitness in community-dwelling older adults This experimental study is a controlled trial. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-dwelling Older Adults
- What is being tested?
- Multimodal exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Dec 2019to 30 Jun 2023
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male or female participants aged ≥65 years;
- Community-dwelling older adults living independently;
Who cannot join
- Presence of cognitive impairment (Mini-Mental State Examination) (11);
- Presence of motor impairment compromising the program participation;
- Presence of neurological problems or diseases compromising the program participation;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Multimodal Exercise Program on Brain Dynamics, Cognitive Functioning and Physical Fitness in Community-dwelling Older Adults
The aim of present study is to analyze the effect of a multimodal exercise program on brain dynamics, cognitive functioning and physical fitness in community-dwelling older adults This experimental study is a controlled trial. Participants will be allocated to two groups: experimental group (who attend the multimodal exercise program) and control group (who maintain usual activity).
The multimodal exercise program will run for 12 weeks (3 sessions / week of 60 minutes).
Participants will be assessed 1) at baseline and at 2) at 12 weeks.
Read the detailed description
Aging is associated with a decline in cognitive functioning (CF), which influence negatively the motor capacities of older adults (1). Differences on dynamic brain, namely reductions in structural and functional connectivity contribute to cognitive decline. However, efficient communications between brain regions works like a prerequisite for CF (2,3).
Programs targeting cognitive functioning improvement evidenced the importance of the information processing speed (IPS). However, IPS may not be the only factor conditioning the relationship between CF and gait in the older people, especially in locomotive tasks that require attention (4). According to Lezak et al. (5), the performance in each area of CF decreases with aging, and the most significant decline is reported on the performance of complex attentional tasks such as selective or divided attention.
Recent studies focusing cognitive or physical fitness programs, have been shown that dual-task (DT) performance, particularly involving walking while performing a task with cognitive interference, predicts the risk of frailty, disability and mortality in older people (6,7).
According Bahureksa, et al. (8), for balance maintenance is needed to incorporate and decipher the sensorimotor information through CF. On the other hand, exercise programs reported as effective strategies for agility, muscle strength and body composition improvement (9, 10). However, no studies were found focusing the effect and benefits of a multimodal exercise program privileging IPS on brain electrical activity, CF and functional fitness in community-dwelling older adults.
This multimodal exercise program, privileging information processing speed and comprising sensorimotor and neurocognitive exercises, may revert the process of loss and decline on brain dynamics, CF and physical fitness in community-dwelling older adults.
- Conditions
- Community-dwelling Older Adults
- Being tested
- Multimodal exercise program
- Keywords
- Older adults, Multimodal exercise program, Brain dynamics, Cognitive functioning, Physical fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal exercise programOther
Each session includes: beginning ritual (5 min), warm-up (15 min), main section comprising the multimodal exercises (30 min), cool-down (5 min), and finishing ritual (5 min). At the initial stage, the activation of different muscle groups will be performed. The main section (multimodal exercises) will be focused on the specific objectives through sensorimotor and neurocognitive activities and will privilege IPS. This section includes periods ranging 10-15 min of exercises mainly focused on motor stimulation - physical fitness (strength, balance and agility) - alternating with exercises mainly focused on cognitive stimulation - CF (planning ability, solving-problems, IPS, attention and DT performance). At the cool-down the participants will normalize their physiological parameters. Finally, at the finishing ritual the participants sign an attendance sheet regarding the session, including perceived exertion (Borg Scale) and satisfaction (Caregiver Treatment Satisfaction questionnaire).
| Study group | Role | What they receive |
|---|---|---|
| Multimodal exercise program | Experimental | The experimental group intervention will attend the multimodal exercise program. The program integrates 3 sessions / week of 60 minutes on alternated days. The multimodal exercise program includes exercises promoting simultaneous motor and cognitive stimulation. Receives: Other: Multimodal exercise program |
| Control Group | No intervention | Usual care. After the study, it will be offered the opportunity to integrate a similar exercise program for the control group (CG) participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline, between and within groups comparison
Dynamic Brain Outcome Measure - Electroencephalographic evaluation to assess frequency analyses in the alpha, theta and beta power spectrum
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Cognitive Functioning Outcome Measure - Tower of London test, ranging from 0 (worst) to 36 (best), to assess problem-solving ability (n)
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Cognitive Functioning Outcome Measure - Tower of London test to assess planning and execution time (s)
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Cognitive Functioning Outcome Measure - Useful Field of View Assessment, ranging from 17 (best) to 500 (worst), to evaluate processing speed, selective and divided attention (ms)
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Physical Fitness Outcome Measure - Timed Up and Go test (single and dual-task version) to assess agility and dual-task performance (s)
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Physical Fitness Outcome Measure - The Ten Step Test to assess agility (s)
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Physical Fitness Outcome Measure - Senior Fitness Test (30-Second Chair Stand) to assess lower body strength (resistance) (n)
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Physical Fitness Outcome Measure - Short Physical Performance Battery (Chair Stand Test) to assess lower body strength (power) (n)
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Physical Fitness Outcome Measure - Fullerton Advanced Balance Scale (modified version), ranging from 0 (worst) to 16 (best) points, to assess balance
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Body Composition Outcome Measure - Bioimpedance analyzer (Tanita® MC-780) to assess body fat mass (%)
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Body Composition Outcome Measure - Bioimpedance analyzer (Tanita® MC-780) to assess body lean mass (%)
Measured: 0, 3 months
Change from Baseline, between and within groups comparison
Body Composition Outcome Measure - Bioimpedance analyzer (Tanita® MC-780) to assess body water (%)
Measured: 0, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start2 Dec 2019
- Primary completion30 Jan 2020
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Community-dwelling 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Collaborators
- São João de Deus School of Nursing, Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA)
- Responsible party
- Principal investigator, Hugo Filipe Zurzica Rosado, University of Évora
- Investigators
- Hugo Rosado, MSc, Principal investigator, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189458
- Sponsor's protocol ID
- Brain Dynamics
- Status last verified
- Mar 2024
- First submitted
- 27 Nov 2019
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lezak MD, Howieson DB, Bigler ED, Tranel, D. Neuropsychological assessment. New York: Oxford University Press, 5th Edition; 2012.
Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins, IP. New normative values of Mini-mental State Examination. Sinapse: Sociedade Portuguesa de Neurologia. 2009 Nov; 9(2): 10-16
Bherer L. Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Ann N Y Acad Sci. 2015 Mar;1337:1-6. doi: 10.1111/nyas.12682.
PubMed 25773610Ferreira LK, Busatto GF. Resting-state functional connectivity in normal brain aging. Neurosci Biobehav Rev. 2013 Mar;37(3):384-400. doi: 10.1016/j.neubiorev.2013.01.017. Epub 2013 Jan 17.
PubMed 23333262Bennett IJ, Madden DJ. Disconnected aging: cerebral white matter integrity and age-related differences in cognition. Neuroscience. 2014 Sep 12;276:187-205. doi: 10.1016/j.neuroscience.2013.11.026. Epub 2013 Nov 23.
PubMed 24280637Holtzer R, Mahoney J, Verghese J. Intraindividual variability in executive functions but not speed of processing or conflict resolution predicts performance differences in gait speed in older adults. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):980-6. doi: 10.1093/gerona/glt180. Epub 2013 Nov 27.
PubMed 24285744Verghese J, Holtzer R, Lipton RB, Wang C. Mobility stress test approach to predicting frailty, disability, and mortality in high-functioning older adults. J Am Geriatr Soc. 2012 Oct;60(10):1901-5. doi: 10.1111/j.1532-5415.2012.04145.x. Epub 2012 Sep 24.
PubMed 23002714Brustio PR, Magistro D, Zecca M, Rabaglietti E, Liubicich ME. Age-related decrements in dual-task performance: Comparison of different mobility and cognitive tasks. A cross sectional study. PLoS One. 2017 Jul 21;12(7):e0181698. doi: 10.1371/journal.pone.0181698. eCollection 2017.
PubMed 28732080Bahureksa L, Najafi B, Saleh A, Sabbagh M, Coon D, Mohler MJ, Schwenk M. The Impact of Mild Cognitive Impairment on Gait and Balance: A Systematic Review and Meta-Analysis of Studies Using Instrumented Assessment. Gerontology. 2017;63(1):67-83. doi: 10.1159/000445831. Epub 2016 May 13.
PubMed 27172932Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Latorre Roman PA, Garcia-Pinillos F, Huertas Herrador JA, Cozar Barba M, Munoz Jimenez M. Relationship between sex, body composition, gait speed and body satisfaction in elderly people. Nutr Hosp. 2014 Oct 1;30(4):851-7. doi: 10.3305/nh.2014.30.4.7669.
PubMed 25335673
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multimodal Exercise Program on Brain Dynamics, Cognitive Functioning and Physical Fitness in Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT04189458
- Acronym / sponsor ID
- Brain Dynamics
- Conditions
- Community-dwelling Older Adults
- Keywords
- Older adults, Multimodal exercise program, Brain dynamics, Cognitive functioning, Physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Collaborators
- São João de Deus School of Nursing, Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA)
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 Dec 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.
The aim of present study is to analyze the effect of a multimodal exercise program on brain dynamics, cognitive functioning and physical fitness in community-dwelling older adults This experimental study is a controlled trial. Participants will be allocated to two groups: experimental group (who attend the multimodal exercise program) and control group (who maintain usual activity).
The multimodal exercise program will run for 12 weeks (3 sessions / week of 60 minutes).
Participants will be assessed 1) at baseline and at 2) at 12 weeks.
Detailed description
Aging is associated with a decline in cognitive functioning (CF), which influence negatively the motor capacities of older adults (1). Differences on dynamic brain, namely reductions in structural and functional connectivity contribute to cognitive decline. However, efficient communications between brain regions works like a prerequisite for CF (2,3).
Programs targeting cognitive functioning improvement evidenced the importance of the information processing speed (IPS). However, IPS may not be the only factor conditioning the relationship between CF and gait in the older people, especially in locomotive tasks that require attention (4). According to Lezak et al. (5), the performance in each area of CF decreases with aging, and the most significant decline is reported on the performance of complex attentional tasks such as selective or divided attention.
Recent studies focusing cognitive or physical fitness programs, have been shown that dual-task (DT) performance, particularly involving walking while performing a task with cognitive interference, predicts the risk of frailty, disability and mortality in older people (6,7).
According Bahureksa, et al. (8), for balance maintenance is needed to incorporate and decipher the sensorimotor information through CF. On the other hand, exercise programs reported as effective strategies for agility, muscle strength and body composition improvement (9, 10). However, no studies were found focusing the effect and benefits of a multimodal exercise program privileging IPS on brain electrical activity, CF and functional fitness in community-dwelling older adults.
This multimodal exercise program, privileging information processing speed and comprising sensorimotor and neurocognitive exercises, may revert the process of loss and decline on brain dynamics, CF and physical fitness in community-dwelling older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal exercise program | Experimental | Other: Multimodal exercise programThe experimental group intervention will attend the multimodal exercise program. The program integrates 3 sessions / week of 60 minutes on alternated days. The multimodal exercise program includes exercises promoting simultaneous motor and cognitive stimulation. |
| Control Group | No intervention | –Usual care. After the study, it will be offered the opportunity to integrate a similar exercise program for the control group (CG) participants. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Male or female participants aged ≥65 years;
- Community-dwelling older adults living independently;
Key exclusion criteria (3 listed)
- Presence of cognitive impairment (Mini-Mental State Examination) (11);
- Presence of motor impairment compromising the program participation;
- Presence of neurological problems or diseases compromising the program participation;
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 |
|---|---|---|
| Multimodal exercise programEach session includes: beginning ritual (5 min), warm-up (15 min), main section comprising the multimodal exercises (30 min), cool-down (5 min), and finishing ritual (5 min). At the initial stage, the activation of different muscle groups will be performed. The main section (multimodal exercises) will be focused on the specific objectives through sensorimotor and neurocognitive activities and will privilege IPS. This section includes periods ranging 10-15 min of exercises mainly focused on motor stimulation - physical fitness (strength, balance and agility) - alternating with exercises mainly focused on cognitive stimulation - CF (planning ability, solving-problems, IPS, attention and DT performance). At the cool-down the participants will normalize their physiological parameters. Finally, at the finishing ritual the participants sign an attendance sheet regarding the session, including perceived exertion (Borg Scale) and satisfaction (Caregiver Treatment Satisfaction questionnaire). | Other | Multimodal exercise program |
Primary outcome
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Dynamic Brain Outcome Measure - Electroencephalographic evaluation to assess frequency analyses in the alpha, theta and beta power spectrum
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Cognitive Functioning Outcome Measure - Tower of London test, ranging from 0 (worst) to 36 (best), to assess problem-solving ability (n)
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Cognitive Functioning Outcome Measure - Tower of London test to assess planning and execution time (s)
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Cognitive Functioning Outcome Measure - Useful Field of View Assessment, ranging from 17 (best) to 500 (worst), to evaluate processing speed, selective and divided attention (ms)
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Physical Fitness Outcome Measure - Timed Up and Go test (single and dual-task version) to assess agility and dual-task performance (s)
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Physical Fitness Outcome Measure - The Ten Step Test to assess agility (s)
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Physical Fitness Outcome Measure - Senior Fitness Test (30-Second Chair Stand) to assess lower body strength (resistance) (n)
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Physical Fitness Outcome Measure - Short Physical Performance Battery (Chair Stand Test) to assess lower body strength (power) (n)
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Physical Fitness Outcome Measure - Fullerton Advanced Balance Scale (modified version), ranging from 0 (worst) to 16 (best) points, to assess balance
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Body Composition Outcome Measure - Bioimpedance analyzer (Tanita® MC-780) to assess body fat mass (%)
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Body Composition Outcome Measure - Bioimpedance analyzer (Tanita® MC-780) to assess body lean mass (%)
Change from Baseline, between and within groups comparison
Time frame: 0, 3 months
Body Composition Outcome Measure - Bioimpedance analyzer (Tanita® MC-780) to assess body water (%)
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 28 Mar 2024.
- BackgroundLezak MD, Howieson DB, Bigler ED, Tranel, D. Neuropsychological assessment. New York: Oxford University Press, 5th Edition; 2012.
- BackgroundMorgado J, Rocha CS, Maruta C, Guerreiro M, Martins, IP. New normative values of Mini-mental State Examination. Sinapse: Sociedade Portuguesa de Neurologia. 2009 Nov; 9(2): 10-16
- Results publication: PubMed 25773610Bherer L. Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Ann N Y Acad Sci. 2015 Mar;1337:1-6. doi: 10.1111/nyas.12682.
- Results publication: PubMed 23333262Ferreira LK, Busatto GF. Resting-state functional connectivity in normal brain aging. Neurosci Biobehav Rev. 2013 Mar;37(3):384-400. doi: 10.1016/j.neubiorev.2013.01.017. Epub 2013 Jan 17.
- Results publication: PubMed 24280637Bennett IJ, Madden DJ. Disconnected aging: cerebral white matter integrity and age-related differences in cognition. Neuroscience. 2014 Sep 12;276:187-205. doi: 10.1016/j.neuroscience.2013.11.026. Epub 2013 Nov 23.
- Results publication: PubMed 24285744Holtzer R, Mahoney J, Verghese J. Intraindividual variability in executive functions but not speed of processing or conflict resolution predicts performance differences in gait speed in older adults. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):980-6. doi: 10.1093/gerona/glt180. Epub 2013 Nov 27.
- Results publication: PubMed 23002714Verghese J, Holtzer R, Lipton RB, Wang C. Mobility stress test approach to predicting frailty, disability, and mortality in high-functioning older adults. J Am Geriatr Soc. 2012 Oct;60(10):1901-5. doi: 10.1111/j.1532-5415.2012.04145.x. Epub 2012 Sep 24.
- Results publication: PubMed 28732080Brustio PR, Magistro D, Zecca M, Rabaglietti E, Liubicich ME. Age-related decrements in dual-task performance: Comparison of different mobility and cognitive tasks. A cross sectional study. PLoS One. 2017 Jul 21;12(7):e0181698. doi: 10.1371/journal.pone.0181698. eCollection 2017.
- Results publication: PubMed 27172932Bahureksa L, Najafi B, Saleh A, Sabbagh M, Coon D, Mohler MJ, Schwenk M. The Impact of Mild Cognitive Impairment on Gait and Balance: A Systematic Review and Meta-Analysis of Studies Using Instrumented Assessment. Gerontology. 2017;63(1):67-83. doi: 10.1159/000445831. Epub 2016 May 13.
- Results publication: PubMed 21694556Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
- Results publication: PubMed 25335673Latorre Roman PA, Garcia-Pinillos F, Huertas Herrador JA, Cozar Barba M, Munoz Jimenez M. Relationship between sex, body composition, gait speed and body satisfaction in elderly people. Nutr Hosp. 2014 Oct 1;30(4):851-7. doi: 10.3305/nh.2014.30.4.7669.
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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.
Hugo Rosado, MSc principal investigator
University of Évora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal exercise program in people with Community-dwelling Older Adults, run by University of Évora at 1 site in Portugal.
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 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 28 Mar 2024. 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 Portugal. 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 from Baseline, between and within groups comparison (time frame: 0, 3 months). The study lists 12 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 NCT04189458, which also lists 11 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 28 Mar 2024.