Down SyndromeNCT04048759
The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
A study testing Remote Low, Remote High and Personal Coach in people with Down Syndrome and Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The objectives of this study are to determine the feasibility and potential efficacy of remotely delivered group exercise sessions to increase daily moderate to vigorous physical activity in adults with Down syndrome, relative to a usual care control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Down Syndrome, Alzheimer Disease
- What is being tested?
- Remote Low, Remote High and Personal Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 22 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 and over.
- Diagnosis of DS as determined by a Community Service Provider operating in our recruitment area under the auspices of a Community Developmental Disability Organization (CDDO).
- Sufficient functional ability to understand directions, communicate preferences, wants and needs through spoken language.
- Living at home with a parent/guardian or in a supported living environment with a caregiver who agrees to serve as a study partner.
- No plans to relocate outside the study area over the next 12 mos.
- Internet access in the home.
Who cannot join
- Diagnosis of dementia as determine by the Cambridge Examination for Mental Disorders of Older People with Down Syndrome and others with intellectual disabilities.
- Unable to participate in MVPA.
- Pregnancy during the previous 6 mos., currently lactating or planned pregnancy in the following 12 mos.
- Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP.
- Unwilling to be randomized.
- Participation in a regular exercise program, i.e. greater than or equal to 20 min/d greater than or equal to 3 d/wk.
- Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The objectives of this study are to determine the feasibility and potential efficacy of remotely delivered group exercise sessions to increase daily moderate to vigorous physical activity in adults with Down syndrome, relative to a usual care control. Participants will be randomized to attend 40 min remotely delivered group moderate to vigorous physical activity (MVPA) sessions at low frequency (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control usual care control (UC). In addition to the group MVPA sessions, participants in both the RL and RH groups will also receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. Content for both the RL and RH arms will be identical with the exception of group session frequency (1 vs. 3/wk.). Participants in the UC arm will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education).The primary aim is to Assess daily MVPA (min) in the RL, RH, and UC arms at baseline, 3, 6, 9, and 12 mos., and obtain effect sizes for change in MVPA over 12-mos.Secondary Aim 1 is to assess the impact of MVPA on cardiovascular fitness, quality of life, cognitive function, and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, and cerebral blood flow) at baseline, 6, and 12 mos. Secondary Aim 2 will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) of RL, RH, and UC interventions.
Read the detailed description
This research study will compare 3 strategies for the delivery of an intervention to increase moderate to vigorous physical activity (MVPA) in community dwelling adults with Down Syndrome; remotely delivered group MVPA sessions at low (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control (UC). Adults (age ≥ 18 yrs.) with Down Syndrome will be randomized (2:2:1) to one of the 3 intervention arms for an 12-mo. trial. Cohorts of ~20 adults with Down Syndrome will be recruited and computer randomized. Participants will be stratified by sex and sequentially randomized by the study statistician. Participants in all arms will be provided with an iPad for intervention delivery, Fitbit for self-monitoring MPA, and will be asked to complete 150 min of MPA/wk. Participants in the RL and RH arms will be asked to complete 40 minutes MVPA sessions delivered via Zoom software on an iPad, RL will be provided 1 session/wk, and RH will be provided 3 sessions/wk. Participants in both the RL and RH groups will also receive one 20-min remotely delivered individual support/education session/wk. with a heath coach to discuss progress and provide support. The UC intervention will follow the traditional approach to promote increased MVPA. Participants will receive an iPad tablet loaded with information regarding increasing MVPA and will also receive resistance bands and a Fitbit for self-monitoring MVPA. Monthly 20-min. education/support sessions, identical to the education/support sessions provided in the RL and RH arms, will be delivered to participants and their caregivers remotely on the iPad using FaceTime. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary outcome, daily MVPA (min) in the RL, RH, and UC arms will be assessed at baseline, 3, 6, 9, and 12 mos. using an accelerometer. All secondary outcomes will be assessed at baselines, 6, and 12 months. Secondary outcomes are to assess the impact of MVPA across the RL, RH, and UC arms on cardiovascular fitness, quality of life, cognitive function and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, cerebral blood flow). Additionally the researchers will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) and safety of RL, RH, and UC arms.
- Conditions
- Down Syndrome, Alzheimer Disease
- Being tested
- Remote Low, Remote High, Personal Coach
- Keywords
- Physical Activity, Exercise
- Medical subject headings
- Down Syndrome, Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote LowBehavioural
Participants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk.
Remote HighBehavioural
Participants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk.
Personal CoachBehavioural
Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.
| Study group | Role | What they receive |
|---|---|---|
| Remote Low | Other | Not described Receives: Behavioral: Remote Low |
| Remote High | Other | Not described Receives: Behavioral: Remote High |
| Personal Coach | Other | Not described Receives: Behavioral: Personal Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day
MVPA was assessed using an ActiGraph tri-axial accelerometer.
Measured: Baseline to 12 months
Secondary outcomes (10)
Cognitive Function
Working memory, processing speed, multitasking, and episodic memory will be assessed at baseline, 6 and, and 12 months, using tests selected from the widely used Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, LTD, Cambridge, UK) for Down syndrome. The CANTAB for Down syndrome uses a battery of tests including multitasking, episodic memory, executive function and processing speed.
Measured: Baseline to 12 months
Cardiovascular Fitness
Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months
Measured: Baseline to 12 months
Change in Quality of Life
Quality of life will be assessed at baseline, 6, and 12 months with the Personal Well-Being Index Intellectual Disability, which contains 7 items, each corresponding to a quality of life domain: standard of living, health, life achievement, personal relationships, personal safety, community connectedness, and future security. Participants answer questions on a 0-4 scale, with 0 being least happy and 4 being most happy.
Measured: Baseline to 12 months
Brain Volume
Brain volume will be measured using structural MRI at baseline, 6, and 12 months
Measured: Baseline to 12 months
Functional Connectivity
Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months.
Measured: Baseline to 12 months
Cerebral Blood Flow
Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months
Measured: Baseline to 12 months
Retention
Retention will be measured by the percentage of participants who complete the 12 month intervention, defined as completing the 12 month outcome assessments.
Measured: Baseline to 12 months
Session Attendance
Session attendance for both group MVPA and education/support sessions from baseline to 12 months will be obtained from records maintained by the health educator, and expressed as the percent of possible sessions. Attendance at group MVPA sessions will be defined as being logged in to the video conference and remaining on the screen for the entire 30-min session. Attendance at individual support/education sessions, for the both exercise and UC conditions, will be defined as answering the FaceTime call, and being present on screen for the entire session.
Measured: Baseline to 12 months
Use of Recorded Exercise Sessions
Use of recorded exercise sessions will be tracked using Dropbox which provides information on how many times each user watched a video.
Measured: Baseline to 12 months
Reported Serious Adverse Event
Safety will be measured by number of participants reporting a serious adverse event, i.e., any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or results in persistent or significant disability/incapacity.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start21 Jan 2020
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Lauren Ptomey, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048759
- Sponsor's protocol ID
- STUDY00143836
- Other IDs
- R01AG063909
- Status last verified
- Jun 2024
- First submitted
- 5 Aug 2019
- Last updated
- 23 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ptomey LT, Aschenbrenner AJ, Helsel B, Bodde A, Clina JG, Danon JC, Lepping R, Martin LE, Brucks M, Sherman JR, Forsha DE, Washburn RA, Donnelly JE. The impact of a 12-month randomized exercise intervention on cognitive function and brain volume in adults with down syndrome. Disabil Health J. 2026 Jul 30:102134. doi: 10.1016/j.dhjo.2026.102134. Online ahead of print.
PubMed 42532804Ptomey LT, Helsel BC, Washburn RA, Montgomery RN, Krebill R, Danon JC, Sherman JR, Forsha D, Bodde A, Szabo-Reed AN, Gorczyca AM, Donnelly JE. The promotion of physical activity for use in Alzheimer's disease prevention trials in adults with Down syndrome: Results from a 12-month randomized trial. Alzheimers Dement (N Y). 2025 Jun 12;11(2):e70115. doi: 10.1002/trc2.70115. eCollection 2025 Apr-Jun.
PubMed 40520478Frank L, Helsel B, Dodd D, Bodde AE, Danon JC, Sherman JR, Forsha DE, Szabo-Reed A, Washburn RA, Donnelly JE, Ptomey LT. The association between cardiovascular health and cognition in adults with Down syndrome. J Neurodev Disord. 2023 Dec 6;15(1):43. doi: 10.1186/s11689-023-09510-z.
PubMed 38057709Dodd D, Helsel B, Bodde AE, Danon JC, Sherman JR, Donnelly JE, Washburn RA, Ptomey LT. The association of increased body mass index on cardiorespiratory fitness, physical activity, and cognition in adults with down syndrome. Disabil Health J. 2023 Oct;16(4):101497. doi: 10.1016/j.dhjo.2023.101497. Epub 2023 Jun 16.
PubMed 37407386Ptomey LT, Szabo-Reed AN, Martin LE, Mayo MS, Washburn RA, Gorczyca AM, Lepping RJ, Lee P, Forsha DE, Sherman JR, Danon JC, Donnelly JE. The promotion of physical activity for the prevention of Alzheimer's disease in adults with Down Syndrome: Rationale and design for a 12 Month randomized trial. Contemp Clin Trials Commun. 2020 Jun 30;19:100607. doi: 10.1016/j.conctc.2020.100607. eCollection 2020 Sep.
PubMed 32642594
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
- ClinicalTrials.gov ID
- NCT04048759
- Acronym / sponsor ID
- STUDY00143836
- Conditions
- Down Syndrome, Alzheimer Disease
- Keywords
- Physical Activity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Posted 23 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to determine the feasibility and potential efficacy of remotely delivered group exercise sessions to increase daily moderate to vigorous physical activity in adults with Down syndrome, relative to a usual care control. Participants will be randomized to attend 40 min remotely delivered group moderate to vigorous physical activity (MVPA) sessions at low frequency (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control usual care control (UC). In addition to the group MVPA sessions, participants in both the RL and RH groups will also receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. Content for both the RL and RH arms will be identical with the exception of group session frequency (1 vs. 3/wk.). Participants in the UC arm will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education).The primary aim is to Assess daily MVPA (min) in the RL, RH, and UC arms at baseline, 3, 6, 9, and 12 mos., and obtain effect sizes for change in MVPA over 12-mos.Secondary Aim 1 is to assess the impact of MVPA on cardiovascular fitness, quality of life, cognitive function, and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, and cerebral blood flow) at baseline, 6, and 12 mos. Secondary Aim 2 will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) of RL, RH, and UC interventions.
Detailed description
This research study will compare 3 strategies for the delivery of an intervention to increase moderate to vigorous physical activity (MVPA) in community dwelling adults with Down Syndrome; remotely delivered group MVPA sessions at low (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control (UC). Adults (age ≥ 18 yrs.) with Down Syndrome will be randomized (2:2:1) to one of the 3 intervention arms for an 12-mo. trial. Cohorts of ~20 adults with Down Syndrome will be recruited and computer randomized. Participants will be stratified by sex and sequentially randomized by the study statistician. Participants in all arms will be provided with an iPad for intervention delivery, Fitbit for self-monitoring MPA, and will be asked to complete 150 min of MPA/wk. Participants in the RL and RH arms will be asked to complete 40 minutes MVPA sessions delivered via Zoom software on an iPad, RL will be provided 1 session/wk, and RH will be provided 3 sessions/wk. Participants in both the RL and RH groups will also receive one 20-min remotely delivered individual support/education session/wk. with a heath coach to discuss progress and provide support. The UC intervention will follow the traditional approach to promote increased MVPA. Participants will receive an iPad tablet loaded with information regarding increasing MVPA and will also receive resistance bands and a Fitbit for self-monitoring MVPA. Monthly 20-min. education/support sessions, identical to the education/support sessions provided in the RL and RH arms, will be delivered to participants and their caregivers remotely on the iPad using FaceTime. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary outcome, daily MVPA (min) in the RL, RH, and UC arms will be assessed at baseline, 3, 6, 9, and 12 mos. using an accelerometer. All secondary outcomes will be assessed at baselines, 6, and 12 months. Secondary outcomes are to assess the impact of MVPA across the RL, RH, and UC arms on cardiovascular fitness, quality of life, cognitive function and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, cerebral blood flow). Additionally the researchers will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) and safety of RL, RH, and UC arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote Low | Other | Behavioral: Remote Low |
| Remote High | Other | Behavioral: Remote High |
| Personal Coach | Other | Behavioral: Personal Coach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 and over.
- Diagnosis of DS as determined by a Community Service Provider operating in our recruitment area under the auspices of a Community Developmental Disability Organization (CDDO).
- Sufficient functional ability to understand directions, communicate preferences, wants and needs through spoken language.
- Living at home with a parent/guardian or in a supported living environment with a caregiver who agrees to serve as a study partner.
- No plans to relocate outside the study area over the next 12 mos.
Key exclusion criteria (7 listed)
- Diagnosis of dementia as determine by the Cambridge Examination for Mental Disorders of Older People with Down Syndrome and others with intellectual disabilities.
- Unable to participate in MVPA.
- Pregnancy during the previous 6 mos., currently lactating or planned pregnancy in the following 12 mos.
- Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP.
- Unwilling to be randomized.
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 |
|---|---|---|
| Remote LowParticipants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. | Behavioural | Remote Low |
| Remote HighParticipants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. | Behavioural | Remote High |
| Personal CoachParticipants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education. | Behavioural | Personal Coach |
Primary outcome
Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day
Time frame: Baseline to 12 months
MVPA was assessed using an ActiGraph tri-axial accelerometer.
10 secondary outcomes
Cognitive Function
Time frame: Baseline to 12 months
Cardiovascular Fitness
Time frame: Baseline to 12 months
Change in Quality of Life
Time frame: Baseline to 12 months
Brain Volume
Time frame: Baseline to 12 months
Functional Connectivity
Time frame: Baseline to 12 months
Cerebral Blood Flow
Time frame: Baseline to 12 months
Retention
Time frame: Baseline to 12 months
Session Attendance
Time frame: Baseline to 12 months
Use of Recorded Exercise Sessions
Time frame: Baseline to 12 months
Reported Serious Adverse Event
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42532804Ptomey LT, Aschenbrenner AJ, Helsel B, Bodde A, Clina JG, Danon JC, Lepping R, Martin LE, Brucks M, Sherman JR, Forsha DE, Washburn RA, Donnelly JE. The impact of a 12-month randomized exercise intervention on cognitive function and brain volume in adults with down syndrome. Disabil Health J. 2026 Jul 30:102134. doi: 10.1016/j.dhjo.2026.102134. Online ahead of print.
- Derived from this study: PubMed 40520478Ptomey LT, Helsel BC, Washburn RA, Montgomery RN, Krebill R, Danon JC, Sherman JR, Forsha D, Bodde A, Szabo-Reed AN, Gorczyca AM, Donnelly JE. The promotion of physical activity for use in Alzheimer's disease prevention trials in adults with Down syndrome: Results from a 12-month randomized trial. Alzheimers Dement (N Y). 2025 Jun 12;11(2):e70115. doi: 10.1002/trc2.70115. eCollection 2025 Apr-Jun.
- Derived from this study: PubMed 38057709Frank L, Helsel B, Dodd D, Bodde AE, Danon JC, Sherman JR, Forsha DE, Szabo-Reed A, Washburn RA, Donnelly JE, Ptomey LT. The association between cardiovascular health and cognition in adults with Down syndrome. J Neurodev Disord. 2023 Dec 6;15(1):43. doi: 10.1186/s11689-023-09510-z.
- Derived from this study: PubMed 37407386Dodd D, Helsel B, Bodde AE, Danon JC, Sherman JR, Donnelly JE, Washburn RA, Ptomey LT. The association of increased body mass index on cardiorespiratory fitness, physical activity, and cognition in adults with down syndrome. Disabil Health J. 2023 Oct;16(4):101497. doi: 10.1016/j.dhjo.2023.101497. Epub 2023 Jun 16.
- Derived from this study: PubMed 32642594Ptomey LT, Szabo-Reed AN, Martin LE, Mayo MS, Washburn RA, Gorczyca AM, Lepping RJ, Lee P, Forsha DE, Sherman JR, Danon JC, Donnelly JE. The promotion of physical activity for the prevention of Alzheimer's disease in adults with Down Syndrome: Rationale and design for a 12 Month randomized trial. Contemp Clin Trials Commun. 2020 Jun 30;19:100607. doi: 10.1016/j.conctc.2020.100607. eCollection 2020 Sep.
- Individual participant dataSharing planned: No
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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.
Lauren Ptomey, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Low, Remote High and Personal Coach in people with Down Syndrome and Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
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 6 inclusion and 7 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 23 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day (time frame: Baseline to 12 months). 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 NCT04048759, which also lists 5 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 23 Jul 2024.