AgingNCT03262714
Effects of Dancing on Cardiovascular and Functional Risk Factors in Older Women.
A study testing Dance, Walking and Stretching in people with Aging and Cardiovascular Risk Factor, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The goal of this randomized controlled trial is to investigate the effects of a dance intervention on cardiovascular risk factors and functional capacity of older women, comparing dancing to a walking exercise intervention and to an active control condition (stretching). Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Cardiovascular Risk Factor, Physical Activity
- What is being tested?
- Dance, Walking and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2017to Aug 2018
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between 60 and 80 years old
- BMI inferior to 35 kg/m2
- Independent for performing daily activities (OARS scale)
- Not engaged in any type of regular exercise programme for the past 6 months
Who cannot join
- Type 2 diabetes mellitus, dyslipidemia, cardiovascular diseases or other non-controlled metabolic disorders
- Chronic diseases such as fibromyalgia, cancer or neurodegenerative disorders
- Bone, joints or muscle problems that could impair exercise performance
- Not being able to perform the effort test in the first assessment session, abnormal electrocardiogram, or any other condition identified by the physician of the study that limit the engagement in an exercise training programme.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
Josianne Rodrigues-Krause, MSc, 55-51-999101821, rodrigues.krause@ufrgs.br
Alvaro Reischak-Oliveira, PhD, 55-51-3308-5862, alvaro.oliveira@ufrgs.br
About this study
Official title: Effects of Dancing and Walking on Cardiovascular Risk Factors and Functional Capacity in Older Women: a Randomized Controlled Trial.
The goal of this randomized controlled trial is to investigate the effects of a dance intervention on cardiovascular risk factors and functional capacity of older women, comparing dancing to a walking exercise intervention and to an active control condition (stretching). The participants will include women between 60 and 80 years old, with body mass index inferior to 35 Kg /m2. The main outcome of this study is the peak oxygen consumption (VO2peak). The secondary outcomes are cardiovascular risk associated factors (C-reactive protein, TNF-alpha, lipid profile, etc) and functional performance (muscle strength and power, balance, gate ability, etc). The experimental design will include 3 parts: 1) Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test, assessments of body composition, balance, gate ability, muscular strength and power. 2) Period of interventions: patients will be randomized to one of the three following groups: dance, walking or stretching. The duration of the interventions will be 8 weeks, including 3 sessions per week for dance and walking, and once a week for the stretching group. Each session will last 60 min. 3) Post-intervention assessments: the same protocols of testing as pre-intervention.
Read the detailed description
The aging process is characterized by reductions of lean mass simultaneously to increases in visceral adipose tissue. Metabolically, this is related to insulin resistance and higher risk to develop cardiovascular diseases. Functionally, loss of strength and cardiorespiratory fitness may lead to early muscle fatigue onset, which may limit the performance of daily activities, and eventually lead to loss of independence with aging. Dancing has been used as a form of exercise to improve functional and metabolic outcomes during aging. However, the field lacks of randomized controlled trials (RCT) evaluating metabolic outcomes related to dance interventions, as well as comparisons of dancing with other types of exercise on functional performance and metabolic health of older adults. Therefore, the goal of this randomized controlled trial is to investigate the effects of a dance intervention on cardiovascular risk factors and functional capacity of older women, comparing dancing to a walking exercise intervention and to an active control condition (stretching). Additionally, we aim to investigate the acute cardiorespiratory responses of a dance session. The participants will include women between 60 and 80 years old, with body mass index inferior to 35 Kg /m2 and independent for performing daily activities. They should not be engaged in any type of regular physical activity in the past 6 months. Exclusion criteria will include type 2 diabetes mellitus, cardiovascular complications and neurodegenerative diseases. The main outcome of this study is the peak oxygen consumption (VO2peak), as it has been associated with both, cardiovascular risk and functional performance in aging individuals. The secondary outcomes are: (1) cardiovascular risk associated factors: C-reactive protein, TNF-alpha, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, fasting glucose and insulin, and homeostatic model assessment of insulin resistance (HOMA-IR). (2) Functional performance: muscle strength and power, balance, gate ability and muscle quality. The experimental design will include 3 parts: 1) Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test, assessments of body composition, balance, gate ability, muscular strength and power. 2) Period of interventions: patients will be randomized in blocks (randomization.com), in accordance to their VO2peak , to one of the three following groups: dance, walking or control. The duration of the dance and walking interventions will be 8 weeks, including 3 sessions per week, each lasting 60 min. Dance classes will be performed in group in a dance studio, including a variety of rhythms such as salsa, jazz and aerobics. Walking sessions will be performed individually or in groups of two people, in a treadmill, at the gym. The control group will have 60min stretching classes once a week, also for 8 weeks. 3) Post-intervention assessments: the same protocols of testing of the pre-interventions assessments will be repeated. All the assessments and interventions will be held at the Laboratory of Research in Exercise (LAPEX-UFRGS).
- Conditions
- Aging, Cardiovascular Risk Factor, Physical Activity
- Being tested
- Dance, Walking, Stretching
- Keywords
- Dance, walking, cardiovascular risk, functional capacity.
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanceOther
Participants randomized to the dance group will take part in a dance intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min. Dance classes will be performed in group in a dance studio, including a variety of rhythms such as salsa, jazz and aerobics. The dance session wil include a warm up of 15 min (posture, join mobility and dance technique), a main part of 40 min (learning of specific choreographies and practice of moves across the floor), and a cool down of 5 min (muscle stretching and relaxation).
WalkingOther
Participants randomized to the walking group will take part in a walking intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min. The walking session will include a warm up of 10 min (posture and join mobility), a main part of 40 min (walking on a treadmill with a heart rate corresponding to 60% of VO2peak), and a cool down of 10 min (muscle stretching and relaxation).
StretchingOther
Participants randomized to the control group will take part in stretching classes, once a week, each lasting 60 min, also for 8 weeks. Stretching exercises for large muscle groups will be performed standing or in a match, holding the positions for a maximum of 10 s. There will be no music playing during the session.
| Study group | Role | What they receive |
|---|---|---|
| Dancing | Experimental | Elderly women randomized to the dance intervention programme. Receives: Other: Dance |
| Walking | Experimental | Elderly women randomized to the walking intervention programme. Receives: Other: Walking |
| Stretching | Active comparator | Elderly women randomized to the stretching intervention programme. Receives: Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen Consumption (VO2peak)
The maximum capacity of oxygen consumption measured during an incremental exercise test.
Measured: Baseline and 8 weeks
Secondary outcomes (22)
Change in C-reactive protein (CRP)
Cardiovascular risk marker. It will be analyzed in plasma, using ELISA specific kits.
Measured: Baseline and 8 weeks
Change in Tumor necrosis factor alpha (TNF-alpha)
Inflammatory marker. It will be analyzed in plasma, using ELISA specific kits.
Measured: Baseline and 8 weeks
Change in Triglycerides
Lipid profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
Measured: Baseline and 8 weeks
Change in Total Cholesterol
Lipid profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
Measured: Baseline and 8 weeks
Change in LDL-Cholesterol
Lipid profile marker. Estimation of the LDL concentration will be calculate using the formula of Friedewald.
Measured: Baseline and 8 weeks
Change in HDL-Cholesterol
Lipid profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
Measured: Baseline and 8 weeks
Change in Fasting Glycemia
Glycaemic profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
Measured: Baseline and 8 weeks
Change in Fasting Insulin
Glycaemic profile marker. It will be measured in plasma, usin a high sensitivity enzyme-linked immunosorbent assay.
Measured: Baseline and 8 weeks
Change in HOMA-IR
Glycaemic profile marker. Homeostatic model of insulin resistance. It will be calculated according to the following formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Measured: Baseline and 8 weeks
Change in Muscle Strength
Isometric peak torque of the knee extensors will be measured using an isokinetic dynamometer (Cybex Norm, EUA).
Measured: Baseline and 8 weeks
Change in Muscle Power
Lower body muscle power will be measured by the performance of the counter movement jump in a force platform.
Measured: Baseline and 8 weeks
Change in Muscle Quality
Echo intensity of the quadriceps will be analyzed by ultrasound images.
Measured: Baseline and 8 weeks
Change in Static Balance
Static balance will be measured by a single leg support balance test, performed with both legs, with the eyes open and closed.
Measured: Baseline and 8 weeks
Change in Dynamic Balance
Dynamic balance will be measured by the Time to Up ang Go (TUG) test.
Measured: Baseline and 8 weeks
Change in Gate ability
Gate ability will be measured in a 10m track, picking up objects and passing over obstacles.
Measured: Baseline and 8 weeks
Change in Body Weight
Measurements of body weight will be measured in a digital scale.
Measured: Baseline and 8 weeks
Change in Waist Circumference
Measurements of waist circumference will be performed with a measuring tape.
Measured: Baseline and 8 weeks
Change in Percentage of Body Fat
Measurements of skinfolds will be taken to calculate the percentage of body fat.
Measured: Baseline and 8 weeks
Change in Sit and Stand ability
The ability to sit and stand in a chair 5 times, as fast as possible.
Measured: Baseline and 8 weeks
Changes in Fall Risk
The risk of fall will be measured by the performance in the TUG test.
Measured: Baseline and 8 weeks
Changes in the Fear of Falling
The fear of falling will be analyzed by the Falls Efficacy Scale-International Brazil (FES-I-Brazil).
Measured: Baseline and 8 weeks
Changes in Quality of Life
Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Aug 2017
- Primary completionDec 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul
- Investigators
- Alvaro Reischak-Oliveira, PhD., Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262714
- Sponsor's protocol ID
- 53834516.0.0000.5347
- Status last verified
- Aug 2017
- First submitted
- 8 Aug 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodrigues-Krause J, Farinha JB, Ramis TR, Macedo RCO, Boeno FP, Dos Santos GC, Vargas J Jr, Lopez P, Grazioli R, Costa RR, Pinto RS, Krause M, Reischak-Oliveira A. Effects of dancing compared to walking on cardiovascular risk and functional capacity of older women: A randomized controlled trial. Exp Gerontol. 2018 Dec;114:67-77. doi: 10.1016/j.exger.2018.10.015. Epub 2018 Oct 31.
PubMed 30389581
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dancing and Walking on Cardiovascular Risk Factors and Functional Capacity in Older Women: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03262714
- Acronym / sponsor ID
- 53834516.0.0000.5347
- Conditions
- Aging, Cardiovascular Risk Factor, Physical Activity
- Keywords
- Dance, walking, cardiovascular risk, functional capacity.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 25 Aug 2017 (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 goal of this randomized controlled trial is to investigate the effects of a dance intervention on cardiovascular risk factors and functional capacity of older women, comparing dancing to a walking exercise intervention and to an active control condition (stretching). The participants will include women between 60 and 80 years old, with body mass index inferior to 35 Kg /m2. The main outcome of this study is the peak oxygen consumption (VO2peak). The secondary outcomes are cardiovascular risk associated factors (C-reactive protein, TNF-alpha, lipid profile, etc) and functional performance (muscle strength and power, balance, gate ability, etc). The experimental design will include 3 parts: 1) Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test, assessments of body composition, balance, gate ability, muscular strength and power. 2) Period of interventions: patients will be randomized to one of the three following groups: dance, walking or stretching. The duration of the interventions will be 8 weeks, including 3 sessions per week for dance and walking, and once a week for the stretching group. Each session will last 60 min. 3) Post-intervention assessments: the same protocols of testing as pre-intervention.
Detailed description
The aging process is characterized by reductions of lean mass simultaneously to increases in visceral adipose tissue. Metabolically, this is related to insulin resistance and higher risk to develop cardiovascular diseases. Functionally, loss of strength and cardiorespiratory fitness may lead to early muscle fatigue onset, which may limit the performance of daily activities, and eventually lead to loss of independence with aging. Dancing has been used as a form of exercise to improve functional and metabolic outcomes during aging. However, the field lacks of randomized controlled trials (RCT) evaluating metabolic outcomes related to dance interventions, as well as comparisons of dancing with other types of exercise on functional performance and metabolic health of older adults. Therefore, the goal of this randomized controlled trial is to investigate the effects of a dance intervention on cardiovascular risk factors and functional capacity of older women, comparing dancing to a walking exercise intervention and to an active control condition (stretching). Additionally, we aim to investigate the acute cardiorespiratory responses of a dance session. The participants will include women between 60 and 80 years old, with body mass index inferior to 35 Kg /m2 and independent for performing daily activities. They should not be engaged in any type of regular physical activity in the past 6 months. Exclusion criteria will include type 2 diabetes mellitus, cardiovascular complications and neurodegenerative diseases. The main outcome of this study is the peak oxygen consumption (VO2peak), as it has been associated with both, cardiovascular risk and functional performance in aging individuals. The secondary outcomes are: (1) cardiovascular risk associated factors: C-reactive protein, TNF-alpha, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, fasting glucose and insulin, and homeostatic model assessment of insulin resistance (HOMA-IR). (2) Functional performance: muscle strength and power, balance, gate ability and muscle quality. The experimental design will include 3 parts: 1) Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test, assessments of body composition, balance, gate ability, muscular strength and power. 2) Period of interventions: patients will be randomized in blocks (randomization.com), in accordance to their VO2peak , to one of the three following groups: dance, walking or control. The duration of the dance and walking interventions will be 8 weeks, including 3 sessions per week, each lasting 60 min. Dance classes will be performed in group in a dance studio, including a variety of rhythms such as salsa, jazz and aerobics. Walking sessions will be performed individually or in groups of two people, in a treadmill, at the gym. The control group will have 60min stretching classes once a week, also for 8 weeks. 3) Post-intervention assessments: the same protocols of testing of the pre-interventions assessments will be repeated. All the assessments and interventions will be held at the Laboratory of Research in Exercise (LAPEX-UFRGS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dancing | Experimental | Other: DanceElderly women randomized to the dance intervention programme. |
| Walking | Experimental | Other: WalkingElderly women randomized to the walking intervention programme. |
| Stretching | Active comparator | Other: StretchingElderly women randomized to the stretching intervention programme. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women between 60 and 80 years old
- BMI inferior to 35 kg/m2
- Independent for performing daily activities (OARS scale)
- Not engaged in any type of regular exercise programme for the past 6 months
Key exclusion criteria (4 listed)
- Type 2 diabetes mellitus, dyslipidemia, cardiovascular diseases or other non-controlled metabolic disorders
- Chronic diseases such as fibromyalgia, cancer or neurodegenerative disorders
- Bone, joints or muscle problems that could impair exercise performance
- Not being able to perform the effort test in the first assessment session, abnormal electrocardiogram, or any other condition identified by the physician of the study that limit the engagement in an exercise training programme.
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 |
|---|---|---|
| DanceParticipants randomized to the dance group will take part in a dance intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min. Dance classes will be performed in group in a dance studio, including a variety of rhythms such as salsa, jazz and aerobics. The dance session wil include a warm up of 15 min (posture, join mobility and dance technique), a main part of 40 min (learning of specific choreographies and practice of moves across the floor), and a cool down of 5 min (muscle stretching and relaxation). | Other | Dancing |
| WalkingParticipants randomized to the walking group will take part in a walking intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min. The walking session will include a warm up of 10 min (posture and join mobility), a main part of 40 min (walking on a treadmill with a heart rate corresponding to 60% of VO2peak), and a cool down of 10 min (muscle stretching and relaxation). | Other | Walking |
| StretchingParticipants randomized to the control group will take part in stretching classes, once a week, each lasting 60 min, also for 8 weeks. Stretching exercises for large muscle groups will be performed standing or in a match, holding the positions for a maximum of 10 s. There will be no music playing during the session. | Other | Stretching |
Primary outcome
Change in Peak Oxygen Consumption (VO2peak)
Time frame: Baseline and 8 weeks
The maximum capacity of oxygen consumption measured during an incremental exercise test.
22 secondary outcomes
Change in C-reactive protein (CRP)
Time frame: Baseline and 8 weeks
Change in Tumor necrosis factor alpha (TNF-alpha)
Time frame: Baseline and 8 weeks
Change in Triglycerides
Time frame: Baseline and 8 weeks
Change in Total Cholesterol
Time frame: Baseline and 8 weeks
Change in LDL-Cholesterol
Time frame: Baseline and 8 weeks
Change in HDL-Cholesterol
Time frame: Baseline and 8 weeks
Change in Fasting Glycemia
Time frame: Baseline and 8 weeks
Change in Fasting Insulin
Time frame: Baseline and 8 weeks
Change in HOMA-IR
Time frame: Baseline and 8 weeks
Change in Muscle Strength
Time frame: Baseline and 8 weeks
Change in Muscle Power
Time frame: Baseline and 8 weeks
Change in Muscle Quality
Time frame: Baseline and 8 weeks
Change in Static Balance
Time frame: Baseline and 8 weeks
Change in Dynamic Balance
Time frame: Baseline and 8 weeks
Change in Gate ability
Time frame: Baseline and 8 weeks
Change in Body Weight
Time frame: Baseline and 8 weeks
Change in Waist Circumference
Time frame: Baseline and 8 weeks
Change in Percentage of Body Fat
Time frame: Baseline and 8 weeks
Change in Sit and Stand ability
Time frame: Baseline and 8 weeks
Changes in Fall Risk
Time frame: Baseline and 8 weeks
Changes in the Fear of Falling
Time frame: Baseline and 8 weeks
Changes in Quality of Life
Time frame: Baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Derived from this study: PubMed 30389581Rodrigues-Krause J, Farinha JB, Ramis TR, Macedo RCO, Boeno FP, Dos Santos GC, Vargas J Jr, Lopez P, Grazioli R, Costa RR, Pinto RS, Krause M, Reischak-Oliveira A. Effects of dancing compared to walking on cardiovascular risk and functional capacity of older women: A randomized controlled trial. Exp Gerontol. 2018 Dec;114:67-77. doi: 10.1016/j.exger.2018.10.015. Epub 2018 Oct 31.
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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.
Alvaro Reischak-Oliveira, PhD. principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance, Walking and Stretching in people with Aging and Cardiovascular Risk Factor, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 25 Aug 2017. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josianne Rodrigues-Krause, MSc. (5551 999101821, rodrigues.krause@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Oxygen Consumption (VO2peak) (time frame: Baseline and 8 weeks). 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 NCT03262714, which also lists 1 linked publication.
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 25 Aug 2017.