RehabilitationNCT05381571
Integrating Reminiscence Technology Into Exercise Programs in Subacute Care
A study testing Motivating reminiscence physical therapy in people with Rehabilitation, run by Bruyère Health Research Institute. at 1 site in Canada.
Trial summary
This study evaluates the feasibility of a randomized controlled trial to evaluate the impact of motivating reminiscence-based therapy on exercise adherence, mood and physical health within a subacute rehabilitation population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Motivating reminiscence physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2023to Apr 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admitted to the LIR (Low-intensity rehabilitation) or CMP (complex medical program) unit/floor where the research study is being conducted. Of note, both units receive low intensity rehabilitation services at baseline.
- Participants capable of providing informed consent or have a SDM capable of providing consent on their behalf
- Sufficient visual abilities to observe images on the domed screen
- Able to comprehend and communicate in English or French
- Minimum height requirement of 5'2" or 157cm in order to successfully fit the BikeAround system's stationary bike.
Who cannot join
- Physical limitations (as determined by the SVH healthcare/physiotherapy team) that prevent use of the jDome BikeAround. This includes:
- 1) Inability to coordinate/move lower limbs effectively to complete pedaling task
- 2) The pedaling exercise causes discomfort/pain greater than expected with physical activity
- 3) Medical treatment prevents usage of the system (i.e. continuous ventilatory needs for patients admitted within the CMP unit)
- Cognitive impairment (as determined by the SVH healthcare/physiotherapy team) that prevent use of the jDome BikeAround, such as:
- 1) Inability to sustain attention to focus on pedaling task
Show all 9Show fewer
- 2) Inability to follow one-step commands.
- Known behavioral abnormalities (e.g. overly aggressive behavior) that in the opinion of the clinical care team might impede any meaningful participation in the project
- Those who are in the opinion of, the attending physician or clinical team, too unwell to participate in the project
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Saint-Vincent Hospital
Ottawa, Ontario, K1R 7A5
Mark Campbell, MD, MSc
About this study
This study evaluates the feasibility of a randomized controlled trial to evaluate the impact of motivating reminiscence-based therapy on exercise adherence, mood and physical health within a subacute rehabilitation population. The jDome BikeAround technology displays user-specified Google Earth images onto a domed screen as the user pedals on a stationary bike, which fosters the experience of bicycling through that given environment. Participants will use the technology for 12 weeks during their regularly scheduled therapy sessions.
Read the detailed description
Adherence to physical activity in older adults and those in a low-intensity rehabilitation program is important with respect to achieving the demonstrated benefits in mobility, physical function and overall health maintenance. Physical activities that incorporate motivational strategies can improve long-term adherence to therapy programs. The jDome BikeAround technology is one example, as it involves reminiscence therapy coupled with stationary bicycling. Participant's are able to visit any familiar locations or places they have wished to visit, thus providing a positive and interactive experience as they engage in physical activity.
Participants will be enrolled for a total of 12 weeks. They will have three 10 minute weekly sessions with the jDome BikeAround during their regularly scheduled therapy sessions. Feasibility will be evaluated by participant recruitment, program completion, rate of adverse events and staff acceptance.
- Conditions
- Rehabilitation
- Being tested
- Motivating reminiscence physical therapy
- Keywords
- Motivating Reminiscence Technology, Feasibility, Exercise Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivating reminiscence physical therapyOther
The jDome BikeAround system involves participants using a stationary bike while their selected location is displayed in front of them on a domed projector screen using Google Street View. Using pedals on the bike they can propel themselves down the street, steer and change direction as they wish.
| Study group | Role | What they receive |
|---|---|---|
| Reminiscence-based physical therapy | Experimental | Participants will use the reminiscence-based technology (jDome BikeAround) for 10-minute sessions for three times per week during the 12 week study enrolment period. Receives: Other: Motivating reminiscence physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment
Determine the feasibility of a future randomized controlled trial to evaluate the impact of the jDome BikeAround system on exercise adherence, mood and physical health within a subacute rehabilitation population. Feasibility will be determined by the ability to recruit 60 participants (based on the average number of patients admitted to the rehab units).
Measured: Baseline
Number of participants retained
Determine the feasibility of a future randomized controlled trial to evaluate the impact of the jDome BikeAround system on exercise adherence, mood and physical health within a subacute rehabilitation population. Feasibility will be determined by the number of sessions participants attended, out of the total number of sessions offered.
Measured: Week 12
Rate of adverse events
The number of adverse events experienced by participants related to the use of the jDome BikeAround will be monitored to evaluate the feasibility of a future randomized controlled trial using this technology.
Measured: Week 12
Staff Acceptance
Staff Acceptance will be determined by measuring the number of sessions staff assign participants to use the jDome BikeAround, out of their total number of therapy sessions (I.e. total sessions assigned to use jDome BikeAround out of total therapy sessions which is 3 weekly sessions x 12 weeks).
Measured: Week 12
Secondary outcomes (10)
Endurance
Total distance (meters) travelled during each jDome BikeAround therapy bike session.
Measured: Total distance (meters) will be measured after each participant session (10 minutes) using the jDome BikeAround. This will occur 3 times per week throughout study duration for 12 weeks
Mood changes
Participant mood changes will be measured following their jDome BikeAround session using The Face Scale developed by Lorish and Maisiak (1986)
Measured: Weekly after a jDome BikeAround session (for 12 weeks)
Functional Independence Measure (FIM score)
Standardized measure of disability used in rehabilitation populations. Measure evaluating 18 functional tasks on a scale of 1 (total care) to 7 (independent). Maximum 126 (best) and minimum is 18 (worst).
Measured: Baseline, week 6, week 12
Satisfaction using jDome BikeAround - Participants
This measure will be assessed using semi-structured interviews
Measured: Baseline, week 6, week 12
Satisfaction using jDome BikeAround - Staff
This measure will be assessed using online surveys for rehabilitation staff. 5-point scale from "strongly disagree, disagree, neutral, agree, strongly agree"
Measured: Baseline, week 6, week 12
Emotional Impact
This measure will be assessed using semi-structured interviews with participants. This will assessed depending on participant verbal responses, not using any particular scale.
Measured: Baseline, week 6, week 12
Impact on overall therapy experience - Participants
This measure will be assessed using semi-structured interviews with participants
Measured: Baseline, week 6, week 12
Impact on overall therapy experience - Staff
This measure will be assessed using online surveys for rehabilitation staff. 5-point scale from "strongly disagree, disagree, neutral, agree, strongly agree"
Measured: Baseline, week 6, week 12
Ease of instruction - Participants
This measure will be assessed using semi-structured interviews with participants
Measured: Baseline, week 6, week 12
Ease of instruction - Staff
This measure will be assessed using online surveys for rehabilitation staff. 3 questions graded on a 5-point scale from "strongly disagree, disagree, neutral, agree, strongly agree"
Measured: Baseline, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study startJul 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All recruited participants will use the reminiscence based physical therapy technology, three times weekly for a total of 12 weeks (average admission duration). The expected study enrolment period is 6 months to allow for multiple sets of participants to be recruited from the same medical unit.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- Bruyere Academic Medical Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381571
- Sponsor's protocol ID
- Bruyere
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hay Group, HCC. Sub-Acute Care Capacity Plan. 2016.
Foley N, McClure JA, Meyer M, Salter K, Bureau Y, Teasell R. Inpatient rehabilitation following stroke: amount of therapy received and associations with functional recovery. Disabil Rehabil. 2012;34(25):2132-8. doi: 10.3109/09638288.2012.676145. Epub 2012 Apr 23.
PubMed 22524794Dijkers MP, Zanca JM. Factors complicating treatment sessions in spinal cord injury rehabilitation: nature, frequency, and consequences. Arch Phys Med Rehabil. 2013 Apr;94(4 Suppl):S115-24. doi: 10.1016/j.apmr.2012.11.047. Epub 2013 Mar 7.
PubMed 23465468Laddu DR, Lavie CJ, Phillips SA, Arena R. Physical activity for immunity protection: Inoculating populations with healthy living medicine in preparation for the next pandemic. Prog Cardiovasc Dis. 2021 Jan-Feb;64:102-104. doi: 10.1016/j.pcad.2020.04.006. Epub 2020 Apr 9. No abstract available.
PubMed 32278694Lin YC, Dai YT, Hwang SL. The effect of reminiscence on the elderly population: a systematic review. Public Health Nurs. 2003 Jul-Aug;20(4):297-306. doi: 10.1046/j.1525-1446.2003.20407.x.
PubMed 12823790de Souto Barreto P, Rolland Y, Vellas B, Maltais M. Association of Long-term Exercise Training With Risk of Falls, Fractures, Hospitalizations, and Mortality in Older Adults: A Systematic Review and Meta-analysis. JAMA Intern Med. 2019 Mar 1;179(3):394-405. doi: 10.1001/jamainternmed.2018.5406.
PubMed 30592475Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.
PubMed 22071817Vogel T, Brechat PH, Lepretre PM, Kaltenbach G, Berthel M, Lonsdorfer J. Health benefits of physical activity in older patients: a review. Int J Clin Pract. 2009 Feb;63(2):303-20. doi: 10.1111/j.1742-1241.2008.01957.x.
PubMed 19196369American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.
PubMed 9624662Rivera-Torres S, Fahey TD, Rivera MA. Adherence to Exercise Programs in Older Adults: Informative Report. Gerontol Geriatr Med. 2019 Jan 22;5:2333721418823604. doi: 10.1177/2333721418823604. eCollection 2019 Jan-Dec.
PubMed 30733977Mora JC, Valencia WM. Exercise and Older Adults. Clin Geriatr Med. 2018 Feb;34(1):145-162. doi: 10.1016/j.cger.2017.08.007. Epub 2017 Oct 10.
PubMed 29129214Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.
PubMed 27557484Bredland EL, Soderstrom S, Vik K. Challenges and motivators to physical activity faced by retired men when ageing: a qualitative study. BMC Public Health. 2018 May 15;18(1):627. doi: 10.1186/s12889-018-5517-3.
PubMed 29764398Schutzer KA, Graves BS. Barriers and motivations to exercise in older adults. Prev Med. 2004 Nov;39(5):1056-61. doi: 10.1016/j.ypmed.2004.04.003.
PubMed 15475041Bennett JA, Winters-Stone K. Motivating older adults to exercise: what works? Age Ageing. 2011 Mar;40(2):148-9. doi: 10.1093/ageing/afq182. Epub 2011 Jan 20. No abstract available.
PubMed 21252038
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Reminiscence Technology Into Exercise Programs in Subacute Care
- ClinicalTrials.gov ID
- NCT05381571
- Acronym / sponsor ID
- Bruyere
- Conditions
- Rehabilitation
- Keywords
- Motivating Reminiscence Technology, Feasibility, Exercise Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- Bruyere Academic Medical Organization
- Study start
- Jul 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 19 May 2022 (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.
This study evaluates the feasibility of a randomized controlled trial to evaluate the impact of motivating reminiscence-based therapy on exercise adherence, mood and physical health within a subacute rehabilitation population. The jDome BikeAround technology displays user-specified Google Earth images onto a domed screen as the user pedals on a stationary bike, which fosters the experience of bicycling through that given environment. Participants will use the technology for 12 weeks during their regularly scheduled therapy sessions.
Detailed description
Adherence to physical activity in older adults and those in a low-intensity rehabilitation program is important with respect to achieving the demonstrated benefits in mobility, physical function and overall health maintenance. Physical activities that incorporate motivational strategies can improve long-term adherence to therapy programs. The jDome BikeAround technology is one example, as it involves reminiscence therapy coupled with stationary bicycling. Participant's are able to visit any familiar locations or places they have wished to visit, thus providing a positive and interactive experience as they engage in physical activity.
Participants will be enrolled for a total of 12 weeks. They will have three 10 minute weekly sessions with the jDome BikeAround during their regularly scheduled therapy sessions. Feasibility will be evaluated by participant recruitment, program completion, rate of adverse events and staff acceptance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All recruited participants will use the reminiscence based physical therapy technology, three times weekly for a total of 12 weeks (average admission duration). The expected study enrolment period is 6 months to allow for multiple sets of participants to be recruited from the same medical unit.
| Arm | Type | Receives |
|---|---|---|
| Reminiscence-based physical therapy | Experimental | Other: Motivating reminiscence physical therapyParticipants will use the reminiscence-based technology (jDome BikeAround) for 10-minute sessions for three times per week during the 12 week study enrolment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted to the LIR (Low-intensity rehabilitation) or CMP (complex medical program) unit/floor where the research study is being conducted. Of note, both units receive low intensity rehabilitation services at baseline.
- Participants capable of providing informed consent or have a SDM capable of providing consent on their behalf
- Sufficient visual abilities to observe images on the domed screen
- Able to comprehend and communicate in English or French
- Minimum height requirement of 5'2" or 157cm in order to successfully fit the BikeAround system's stationary bike.
Key exclusion criteria (9 listed)
- Physical limitations (as determined by the SVH healthcare/physiotherapy team) that prevent use of the jDome BikeAround. This includes:
- 1) Inability to coordinate/move lower limbs effectively to complete pedaling task
- 2) The pedaling exercise causes discomfort/pain greater than expected with physical activity
- 3) Medical treatment prevents usage of the system (i.e. continuous ventilatory needs for patients admitted within the CMP unit)
- Cognitive impairment (as determined by the SVH healthcare/physiotherapy team) that prevent use of the jDome BikeAround, such as:
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 |
|---|---|---|
| Motivating reminiscence physical therapyThe jDome BikeAround system involves participants using a stationary bike while their selected location is displayed in front of them on a domed projector screen using Google Street View. Using pedals on the bike they can propel themselves down the street, steer and change direction as they wish. | Other | Reminiscence-based physical therapy |
Primary outcome
Participant Recruitment
Time frame: Baseline
Determine the feasibility of a future randomized controlled trial to evaluate the impact of the jDome BikeAround system on exercise adherence, mood and physical health within a subacute rehabilitation population. Feasibility will be determined by the ability to recruit 60 participants (based on the average number of patients admitted to the rehab units).
Number of participants retained
Time frame: Week 12
Determine the feasibility of a future randomized controlled trial to evaluate the impact of the jDome BikeAround system on exercise adherence, mood and physical health within a subacute rehabilitation population. Feasibility will be determined by the number of sessions participants attended, out of the total number of sessions offered.
Rate of adverse events
Time frame: Week 12
The number of adverse events experienced by participants related to the use of the jDome BikeAround will be monitored to evaluate the feasibility of a future randomized controlled trial using this technology.
Staff Acceptance
Time frame: Week 12
Staff Acceptance will be determined by measuring the number of sessions staff assign participants to use the jDome BikeAround, out of their total number of therapy sessions (I.e. total sessions assigned to use jDome BikeAround out of total therapy sessions which is 3 weekly sessions x 12 weeks).
10 secondary outcomes
Endurance
Time frame: Total distance (meters) will be measured after each participant session (10 minutes) using the jDome BikeAround. This will occur 3 times per week throughout study duration for 12 weeks
Mood changes
Time frame: Weekly after a jDome BikeAround session (for 12 weeks)
Functional Independence Measure (FIM score)
Time frame: Baseline, week 6, week 12
Satisfaction using jDome BikeAround - Participants
Time frame: Baseline, week 6, week 12
Satisfaction using jDome BikeAround - Staff
Time frame: Baseline, week 6, week 12
Emotional Impact
Time frame: Baseline, week 6, week 12
Impact on overall therapy experience - Participants
Time frame: Baseline, week 6, week 12
Impact on overall therapy experience - Staff
Time frame: Baseline, week 6, week 12
Ease of instruction - Participants
Time frame: Baseline, week 6, week 12
Ease of instruction - Staff
Time frame: Baseline, week 6, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- BackgroundHay Group, HCC. Sub-Acute Care Capacity Plan. 2016.
- Background: PubMed 22524794Foley N, McClure JA, Meyer M, Salter K, Bureau Y, Teasell R. Inpatient rehabilitation following stroke: amount of therapy received and associations with functional recovery. Disabil Rehabil. 2012;34(25):2132-8. doi: 10.3109/09638288.2012.676145. Epub 2012 Apr 23.
- Background: PubMed 23465468Dijkers MP, Zanca JM. Factors complicating treatment sessions in spinal cord injury rehabilitation: nature, frequency, and consequences. Arch Phys Med Rehabil. 2013 Apr;94(4 Suppl):S115-24. doi: 10.1016/j.apmr.2012.11.047. Epub 2013 Mar 7.
- Background: PubMed 32278694Laddu DR, Lavie CJ, Phillips SA, Arena R. Physical activity for immunity protection: Inoculating populations with healthy living medicine in preparation for the next pandemic. Prog Cardiovasc Dis. 2021 Jan-Feb;64:102-104. doi: 10.1016/j.pcad.2020.04.006. Epub 2020 Apr 9. No abstract available.
- Background: PubMed 12823790Lin YC, Dai YT, Hwang SL. The effect of reminiscence on the elderly population: a systematic review. Public Health Nurs. 2003 Jul-Aug;20(4):297-306. doi: 10.1046/j.1525-1446.2003.20407.x.
- Background: PubMed 30592475de Souto Barreto P, Rolland Y, Vellas B, Maltais M. Association of Long-term Exercise Training With Risk of Falls, Fractures, Hospitalizations, and Mortality in Older Adults: A Systematic Review and Meta-analysis. JAMA Intern Med. 2019 Mar 1;179(3):394-405. doi: 10.1001/jamainternmed.2018.5406.
- Background: PubMed 22071817Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.
- Background: PubMed 19196369Vogel T, Brechat PH, Lepretre PM, Kaltenbach G, Berthel M, Lonsdorfer J. Health benefits of physical activity in older patients: a review. Int J Clin Pract. 2009 Feb;63(2):303-20. doi: 10.1111/j.1742-1241.2008.01957.x.
- Background: PubMed 9624662American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.
- Background: PubMed 30733977Rivera-Torres S, Fahey TD, Rivera MA. Adherence to Exercise Programs in Older Adults: Informative Report. Gerontol Geriatr Med. 2019 Jan 22;5:2333721418823604. doi: 10.1177/2333721418823604. eCollection 2019 Jan-Dec.
- Background: PubMed 29129214Mora JC, Valencia WM. Exercise and Older Adults. Clin Geriatr Med. 2018 Feb;34(1):145-162. doi: 10.1016/j.cger.2017.08.007. Epub 2017 Oct 10.
- Background: PubMed 27557484Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivating reminiscence physical therapy in people with Rehabilitation, run by Bruyère Health Research Institute. at 1 site in Canada.
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 9 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Mark Campbell, MD, MSc (613-562-6262 ext. 4064, tcampbell@bruyere.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment (time frame: Baseline). The study lists 4 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 NCT05381571, which also lists 20 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 15 Feb 2023.