Spinal Cord InjuriesSMART-HEALTHNCT04726891
Feasibility of the First Known Adaptive Intervention for People With SCI
A study testing Movement-2-Music + Social Networking Support in people with Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The overall goal of the proposed research is to conduct a pilot study to test the feasibility and acceptability of a home-based exercise intervention (SMART-HEALTH). The primary purpose of the pilot study is to assess the feasibility of intervention delivery (Aim 1), the acceptability of the intervention by… Read more about this study
- Who is it for?
- Ages 18 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Movement-2-Music + Social Networking Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2022to 15 Oct 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 18 to 71 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SCI greater than or equal to 1 year after injury
- Wheelchair User
- Able to use arms for exercise
- 18+ years old
- Sedentary (<60 minutes of exercise/week)
Who cannot join
- Cognitive Impairment (Folstein's Mini-Mental State Exam Score < 24)
- Depression (Centers for Epidemiological Studies Depression Scale Score > 16)
- Poorly controlled blood pressure (SBP > 159 or DBP > 95 mmHg)
- Cardiovascular disease event within the past 6 months, severe pulmonary disease, kidney failure
- Active pressure ulcers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of the First Known Adaptive Intervention Delivering Innovative Exercise Program Optimized for People With SCI
The overall goal of the proposed research is to conduct a pilot study to test the feasibility and acceptability of a home-based exercise intervention (SMART-HEALTH). The primary purpose of the pilot study is to assess the feasibility of intervention delivery (Aim 1), the acceptability of the intervention by participants (Aim 2) and estimate effect sizes for a future trial (Aim 3).
Read the detailed description
The proposed project aims to address low adherence to exercise interventions among people with SCI. Specifically, we will conduct a 12-week pilot study of a SMART design using a telehealth-delivered intervention previously developed for people with mobility disability as the primary intervention strategy. This intervention, Movement-to-Music (M2M), has been previously packaged as a collection of videos disseminated through an app on a weekly schedule. M2M has been shown to effectively improve physiological outcomes among people with a neurological disability, including SCI. Data collection will include accelerometer-based measurement of physical activity and sleep during the intervention, a 3-day physical activity recall, and assessment of physiological (e.g., grip strength) and psychosocial factors (i.e., depression, anxiety) collected before and after intervention. Social Cognitive Theory has been used successfully in past studies to improve many health behaviors. Thus, it will be utilized into SMART-HEALTH as the following constructs: self-efficacy, self-regulation, social support, and outcome expectations.
A sample of individuals with SCI will be randomized to 3 weeks or 6 weeks of M2M with social networking support for the first treatment stage. Depending on adherence, they will either continue with the intervention received in the first treatment stage or be randomized a second time. Specifically, participants with high adherence (40 or more minutes) will continue M2M with social networking support, while those with low adherence (less than 40 minutes) will be randomized to an augmented arm that includes individualized behavioral coaching or to an arm that switches to M2M Live. The second treatment stage will last until the participant has completed a total of 12 weeks on the program. The social networking support, individualized behavioral coaching, and M2M Live sessions will be completed through secure videoconferencing on the mobile health platform, which will allow a singular location for tracking intervention activity. All security features of the integrated videoconferencing software will be used, including passwords and waiting rooms.
M2M. In the first treatment stage, all participants will receive M2M as the evidence-based home exercise intervention. M2M is provided in the form of an exercise routine that includes aerobic and strength training set to music. Each week the participants will receive a set of exercise videos, which they will be asked to complete 3 times during the week. Exercise videos begin with a low dose of minutes, approximately 10 to 15 minutes for a total of 40 minutes for the week, and increase by 3-5 minutes each week.
Social Networking Support. In the first treatment stage, all participants will also receive social networking support. The group will also be able to communicate through the mobile health platform via features such as messaging, posting, commenting, and liking. Each week a discussion board will provide an opportunity for participants to post comments concerning the week's exercise content, weekly article, and/or their experience with the program that week.
Individual Behavioral Coaching. Some participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. Half of these participants will receive M2M plus social networking support augmented with individualized behavioral coaching.
M2M Live. The remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. This involves one-on-one tele-exercise training with an M2M instructor. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor one time per week for an exercise session. The exercise session will be recorded and posted for the participant to complete 2 additional times.
- Conditions
- Spinal Cord Injuries
- Being tested
- Movement-2-Music + Social Networking Support
- Keywords
- exercise, behavioral coaching
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement-2-Music + Social Networking SupportBehavioural
Also called Individual Behavioral Coaching; Movement-2-Music Live
The primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support.
| Study group | Role | What they receive |
|---|---|---|
| Continued M2M + SNS for 9 weeks | Active comparator | Participants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 9 weeks of the study. Receives: Behavioral: Movement-2-Music + Social Networking Support |
| Augmented M2M + SNS + IBC for 9 weeks | Active comparator | Some participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. these participants will receive M2M plus social networking support augmented with individualized behavioral coaching. Individualized behavioral coaching involves a weekly coaching session to improve self-regulatory skills based on prior and individualized exercise prescription. The exercise prescriptions are determined by the coach and individual based on their current activity level and a 4-week goal. An example of tailoring the exercise prescribed involves setting a goal of completing the exercise routine one time for the upcoming week instead of three times. The coach will be trained in motivational interviewing to help the participant modify their exercise habits. Receives: Behavioral: Movement-2-Music + Social Networking Support |
| Switched M2M Live for 9 weeks | Active comparator | The remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. M2M Live involves one-on-one tele-exercise training with an M2M instructor, which provides accountability and immediate, tailored feedback along with custom movements and music. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor 1 time each week for an exercise session. The M2M Live instructors are also trained in motivational interviewing in order to coach participants through any barriers to changing their exercise behavior. Receives: Behavioral: Movement-2-Music + Social Networking Support |
| Continued M2M + IBC for 6 weeks | Active comparator | Participants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 6 weeks of the study. Receives: Behavioral: Movement-2-Music + Social Networking Support |
| Augmented M2M + SNS + IBC for 6 weeks | Active comparator | Some participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. these participants will receive M2M plus social networking support augmented with individualized behavioral coaching. Individualized behavioral coaching involves a weekly coaching session to improve self-regulatory skills based on prior and individualized exercise prescription. The exercise prescriptions are determined by the coach and individual based on their current activity level and a 4-week goal. An example of tailoring the exercise prescribed involves setting a goal of completing the exercise routine one time for the upcoming week instead of three times. The coach will be trained in motivational interviewing to help the participant modify their exercise habits. Receives: Behavioral: Movement-2-Music + Social Networking Support |
| Switched M2M Live for 6 weeks | Active comparator | The remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. M2M Live involves one-on-one tele-exercise training with an M2M instructor, which provides accountability and immediate, tailored feedback along with custom movements and music. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor 1 time each week for an exercise session. The M2M Live instructors are also trained in motivational interviewing in order to coach participants through any barriers to changing their exercise behavior. Receives: Behavioral: Movement-2-Music + Social Networking Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Physical Activity Recall Among people with Spinal Cord Injury (PARA-SCI) Instrument will be used to assess minutes of physical activity. Designed to estimate 3-day summary values for physical activity, including intensity (mild, moderate, or vigorous), duration, and modality (aerobic or strength training), which results in providing total minutes of moderate to vigorous physical activity. The higher number of minutes the better.
Measured: baseline, 4-weeks, 8-weeks, and 12 weeks
Secondary outcomes (11)
Strength
Grip strength
Measured: baseline and 12 weeks
Respiratory functioning
Peak Expiratory Volume measured by spirometer
Measured: baseline and 12 weeks
Blood pressure
Two readings prior to exercise using digital blood pressure cuff.
Measured: baseline and 12 weeks
Heart rate
Two readings prior to exercise using digital blood pressure cuff.
Measured: baseline and 12 weeks
Physical activity self-efficacy scale
Survey of social cognitive theory construct.
Measured: baseline and 12 weeks
Outcomes expectations for exercise scale
Survey of social cognitive theory construct.
Measured: baseline and 12 weeks
demographics
questionnaire including age, sex, race, ethnicity
Measured: baseline and 12 weeks
sleep disturbance
Secondary health conditions NIH PROMIS
Measured: baseline and 12 weeks
Depression
Secondary health conditions NIH PROMIS
Measured: baseline and 12 weeks
Pain intensity
Secondary health conditions NIH PROMIS
Measured: baseline and 12 weeks
Anxiety
Secondary health conditions NIH PROMIS
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start26 Jun 2022
- Primary completion1 Oct 2023
- Study completion15 Oct 2023
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 Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Factorial
- Model description
- sequential multiple assignment randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Lakeshore Foundation
- Responsible party
- Principal investigator, Jereme Wilroy, University of Alabama at Birmingham
- Investigators
- Jereme D Wilroy, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726891
- Sponsor's protocol ID
- 645335
- Other IDs
- 645335
- Acronym
- SMART-HEALTH
- Status last verified
- Jul 2024
- First submitted
- 21 Jan 2021
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilroy J, Kim Y, Lai B, Young HJ, Giannone J, Powell D, Thirumalai M, Mehta T, Rimmer J. Increasing Physical Activity in Persons With Spinal Cord Injury With an eHealth-Based Adaptive Exercise Intervention: Protocol for a Sequential Multiple Assignment Randomized Trial. JMIR Res Protoc. 2023 Jul 27;12:e47665. doi: 10.2196/47665.
PubMed 37498650
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the First Known Adaptive Intervention Delivering Innovative Exercise Program Optimized for People With SCI
- ClinicalTrials.gov ID
- NCT04726891
- Acronym / sponsor ID
- SMART-HEALTH / 645335
- Conditions
- Spinal Cord Injuries
- Keywords
- exercise, behavioral coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Lakeshore Foundation
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 27 Jan 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.
The overall goal of the proposed research is to conduct a pilot study to test the feasibility and acceptability of a home-based exercise intervention (SMART-HEALTH). The primary purpose of the pilot study is to assess the feasibility of intervention delivery (Aim 1), the acceptability of the intervention by participants (Aim 2) and estimate effect sizes for a future trial (Aim 3).
Detailed description
The proposed project aims to address low adherence to exercise interventions among people with SCI. Specifically, we will conduct a 12-week pilot study of a SMART design using a telehealth-delivered intervention previously developed for people with mobility disability as the primary intervention strategy. This intervention, Movement-to-Music (M2M), has been previously packaged as a collection of videos disseminated through an app on a weekly schedule. M2M has been shown to effectively improve physiological outcomes among people with a neurological disability, including SCI. Data collection will include accelerometer-based measurement of physical activity and sleep during the intervention, a 3-day physical activity recall, and assessment of physiological (e.g., grip strength) and psychosocial factors (i.e., depression, anxiety) collected before and after intervention. Social Cognitive Theory has been used successfully in past studies to improve many health behaviors. Thus, it will be utilized into SMART-HEALTH as the following constructs: self-efficacy, self-regulation, social support, and outcome expectations.
A sample of individuals with SCI will be randomized to 3 weeks or 6 weeks of M2M with social networking support for the first treatment stage. Depending on adherence, they will either continue with the intervention received in the first treatment stage or be randomized a second time. Specifically, participants with high adherence (40 or more minutes) will continue M2M with social networking support, while those with low adherence (less than 40 minutes) will be randomized to an augmented arm that includes individualized behavioral coaching or to an arm that switches to M2M Live. The second treatment stage will last until the participant has completed a total of 12 weeks on the program. The social networking support, individualized behavioral coaching, and M2M Live sessions will be completed through secure videoconferencing on the mobile health platform, which will allow a singular location for tracking intervention activity. All security features of the integrated videoconferencing software will be used, including passwords and waiting rooms.
M2M. In the first treatment stage, all participants will receive M2M as the evidence-based home exercise intervention. M2M is provided in the form of an exercise routine that includes aerobic and strength training set to music. Each week the participants will receive a set of exercise videos, which they will be asked to complete 3 times during the week. Exercise videos begin with a low dose of minutes, approximately 10 to 15 minutes for a total of 40 minutes for the week, and increase by 3-5 minutes each week.
Social Networking Support. In the first treatment stage, all participants will also receive social networking support. The group will also be able to communicate through the mobile health platform via features such as messaging, posting, commenting, and liking. Each week a discussion board will provide an opportunity for participants to post comments concerning the week's exercise content, weekly article, and/or their experience with the program that week.
Individual Behavioral Coaching. Some participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. Half of these participants will receive M2M plus social networking support augmented with individualized behavioral coaching.
M2M Live. The remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. This involves one-on-one tele-exercise training with an M2M instructor. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor one time per week for an exercise session. The exercise session will be recorded and posted for the participant to complete 2 additional times.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- sequential multiple assignment randomized trial
| Arm | Type | Receives |
|---|---|---|
| Continued M2M + SNS for 9 weeks | Active comparator | Behavioral: Movement-2-Music + Social Networking SupportParticipants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 9 weeks of the study. |
| Augmented M2M + SNS + IBC for 9 weeks | Active comparator | Behavioral: Movement-2-Music + Social Networking SupportSome participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. these participants will receive M2M plus social networking support augmented with individualized behavioral coaching. Individualized behavioral coaching involves a weekly coaching session to improve self-regulatory skills based on prior and individualized exercise prescription. The exercise prescriptions are determined by the coach and individual based on their current activity level and a 4-week goal. An example of tailoring the exercise prescribed involves setting a goal of completing the exercise routine one time for the upcoming week instead of three times. The coach will be trained in motivational interviewing to help the participant modify their exercise habits. |
| Switched M2M Live for 9 weeks | Active comparator | Behavioral: Movement-2-Music + Social Networking SupportThe remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. M2M Live involves one-on-one tele-exercise training with an M2M instructor, which provides accountability and immediate, tailored feedback along with custom movements and music. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor 1 time each week for an exercise session. The M2M Live instructors are also trained in motivational interviewing in order to coach participants through any barriers to changing their exercise behavior. |
| Continued M2M + IBC for 6 weeks | Active comparator | Behavioral: Movement-2-Music + Social Networking SupportParticipants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 6 weeks of the study. |
| Augmented M2M + SNS + IBC for 6 weeks | Active comparator | Behavioral: Movement-2-Music + Social Networking SupportSome participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. these participants will receive M2M plus social networking support augmented with individualized behavioral coaching. Individualized behavioral coaching involves a weekly coaching session to improve self-regulatory skills based on prior and individualized exercise prescription. The exercise prescriptions are determined by the coach and individual based on their current activity level and a 4-week goal. An example of tailoring the exercise prescribed involves setting a goal of completing the exercise routine one time for the upcoming week instead of three times. The coach will be trained in motivational interviewing to help the participant modify their exercise habits. |
| Switched M2M Live for 6 weeks | Active comparator | Behavioral: Movement-2-Music + Social Networking SupportThe remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. M2M Live involves one-on-one tele-exercise training with an M2M instructor, which provides accountability and immediate, tailored feedback along with custom movements and music. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor 1 time each week for an exercise session. The M2M Live instructors are also trained in motivational interviewing in order to coach participants through any barriers to changing their exercise behavior. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- SCI greater than or equal to 1 year after injury
- Wheelchair User
- Able to use arms for exercise
- 18+ years old
- Sedentary (<60 minutes of exercise/week)
Key exclusion criteria (5 listed)
- Cognitive Impairment (Folstein's Mini-Mental State Exam Score < 24)
- Depression (Centers for Epidemiological Studies Depression Scale Score > 16)
- Poorly controlled blood pressure (SBP > 159 or DBP > 95 mmHg)
- Cardiovascular disease event within the past 6 months, severe pulmonary disease, kidney failure
- Active pressure ulcers
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 |
|---|---|---|
| Movement-2-Music + Social Networking SupportAlso: Individual Behavioral Coaching; Movement-2-Music LiveThe primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support. | Behavioural | Augmented M2M + SNS + IBC for 6 weeks, Augmented M2M + SNS + IBC for 9 weeks, Continued M2M + IBC for 6 weeks, Continued M2M + SNS for 9 weeks, Switched M2M Live for 6 weeks, Switched M2M Live for 9 weeks |
Primary outcome
Physical Activity
Time frame: baseline, 4-weeks, 8-weeks, and 12 weeks
Physical Activity Recall Among people with Spinal Cord Injury (PARA-SCI) Instrument will be used to assess minutes of physical activity. Designed to estimate 3-day summary values for physical activity, including intensity (mild, moderate, or vigorous), duration, and modality (aerobic or strength training), which results in providing total minutes of moderate to vigorous physical activity. The higher number of minutes the better.
11 secondary outcomes
Strength
Time frame: baseline and 12 weeks
Respiratory functioning
Time frame: baseline and 12 weeks
Blood pressure
Time frame: baseline and 12 weeks
Heart rate
Time frame: baseline and 12 weeks
Physical activity self-efficacy scale
Time frame: baseline and 12 weeks
Outcomes expectations for exercise scale
Time frame: baseline and 12 weeks
demographics
Time frame: baseline and 12 weeks
sleep disturbance
Time frame: baseline and 12 weeks
Depression
Time frame: baseline and 12 weeks
Pain intensity
Time frame: baseline and 12 weeks
Anxiety
Time frame: baseline and 12 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 15 Jul 2024.
- Derived from this study: PubMed 37498650Wilroy J, Kim Y, Lai B, Young HJ, Giannone J, Powell D, Thirumalai M, Mehta T, Rimmer J. Increasing Physical Activity in Persons With Spinal Cord Injury With an eHealth-Based Adaptive Exercise Intervention: Protocol for a Sequential Multiple Assignment Randomized Trial. JMIR Res Protoc. 2023 Jul 27;12:e47665. doi: 10.2196/47665.
- 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.
Jereme D Wilroy, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement-2-Music + Social Networking Support in people with Spinal Cord Injuries, run by University of Alabama at Birmingham 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 5 inclusion and 5 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 15 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?
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?
Physical Activity (time frame: baseline, 4-weeks, 8-weeks, and 12 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 NCT04726891, 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 15 Jul 2024.