Emotional Well-beingNCT07862478
Feasibility of a Mind-Body Intervention for Optimism
A study testing Emotional Well-Being Writing, Chair-Assisted Squats and Slow-Paced Breathing in people with Emotional Well-being and Psychological Stress, run by Penn State University at 1 site in United States.
Trial summary
This pilot study tests whether three brief mind-body activities can be delivered remotely to midlife adults, and whether they show early signs of improving cardiovascular health, emotional well-being, and stress. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Well-being, Psychological Stress, Cardiovascular Risk
- What is being tested?
- Emotional Well-Being Writing, Chair-Assisted Squats and Slow-Paced Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to 29 Jun 2026
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40 to 65 years
- Able to read and write in English
- Sedentary lifestyle, defined as fewer than 150 minutes per week of moderate-intensity physical activity and no structured exercise regimen in the past 6 months
- Access to a computer or laptop and stable internet for Zoom sessions
- Able to rise from a standard chair to standing without physical assistance and lower back into the chair in a controlled manner
- Able to commit to 30-minute sessions 5 times per week for 4 consecutive weeks
- Willing to provide a blood sample
- Blood pressure below 140/90 mmHg, or blood pressure of 140/90 mmHg or higher that is treated with antihypertensive medication
Who cannot join
- Cardiovascular or respiratory disease
- Symptoms of major disease
- Systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher without antihypertensive medication
- Musculoskeletal limitations that impair squat performance
- Surgical procedure within the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Mechanisms of Action: The Impact of Emotional WellBeing Intervention in Increasing Optimism and Biological Markers
This pilot study tests whether three brief mind-body activities can be delivered remotely to midlife adults, and whether they show early signs of improving cardiovascular health, emotional well-being, and stress. The activities are an emotional well-being writing exercise, two minutes of chair-assisted squats, and five minutes of slow-paced breathing. Insufficiently active adults aged 40 to 65 years are randomly assigned to one of eight groups. The groups cover every combination of the three activities, including one group that receives none. Participants complete their assigned activities in live Zoom sessions with a research assistant on five weekdays per week for four weeks (20 sessions). Blood pressure, heart rate, heart rate variability, a small blood sample, and questionnaires on emotional well-being and stress are collected at in-person visits before and after the four weeks. Participants also rate how they feel immediately before and during each activity.
Read the detailed description
This is a pilot randomized trial with a 2x2x2 full factorial design, conducted in the preparation phase of the multiphase optimization strategy (MOST). Three intervention components are each set to on or off: emotional well-being writing, chair-assisted squats, and slow-paced breathing. Crossing the three factors gives eight conditions, including a condition in which no component is delivered.
The study has two aims. Aim 1 is to assess the feasibility and acceptability of the factorial trial, including recruitment, retention, delivery of the components, adherence, and collection of biobehavioral measures. Aim 2 is to explore the preliminary effects of the components on cardiovascular measures, emotional well-being, and psychological stress.
All participants complete an in-person baseline visit that includes capillary blood collection, self-report questionnaires, and a 5-minute seated recording of beat-to-beat blood pressure and electrocardiography. Participants are then randomized. Those assigned to at least one component attend live Zoom sessions with a trained research assistant on 5 weekdays per week for 4 weeks (20 sessions of up to 30 minutes). Assigned components are delivered in a fixed order of squats, breathing, and writing. Participants assigned to no component do not attend Zoom sessions. They complete a daily affect rating by emailed survey and a weekly safety survey. All participants return for an in-person post-intervention visit with the same measures and a feasibility questionnaire.
Affective response to each component is measured in every session with the Feeling Scale, a single item rated from -5 (very bad) to +5 (very good). Research assistants ask the item aloud immediately before each component and once during it, at minute 1 of squats, minute 2 of breathing, and minute 5 of writing.
The protocol allowed enrollment of up to 80 participants. Forty-three participants were enrolled between November 2025 and May 2026, and the last post-intervention visit took place in June 2026. This record was registered after data collection was complete. Outcome measures are listed as specified in the protocol approved by the institutional review board.
- Being tested
- Emotional Well-Being Writing, Chair-Assisted Squats, Slow-Paced Breathing
- Keywords
- multiphase optimization strategy, factorial design, slow-paced breathing;, chair-assisted squats, writing intervention, optimism, heart rate variability, affective response
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Well-Being WritingBehavioural
A structured writing exercise of 10 to 15 minutes, completed in an online workbook during each live Zoom session on 5 weekdays per week for 4 weeks (20 sessions). Sessions 1 to 12 used forgiveness-focused prompts. Sessions 13 to 20 used positive psychology prompts, including gratitude, personal strengths, and best possible self. Research assistants did not give feedback on writing content.
Chair-Assisted SquatsBehavioural
Two minutes of chair-assisted squats in each live Zoom session on 5 weekdays per week for 4 weeks (20 sessions), supervised by a research assistant. Participants aimed for about 80 percent of the repetitions they completed in a supervised 2-minute baseline test, which was stopped with about three repetitions in reserve. A chair without wheels was placed behind the participant. Participants could stop or switch to marching in place at any time.
Slow-Paced BreathingBehavioural
Five minutes of paced breathing at 6 breaths per minute in each live Zoom session on 5 weekdays per week for 4 weeks (20 sessions). Participants followed an on-screen visual pacer (EZ-Air), inhaling through the nose as a ball rose and exhaling through pursed lips as it fell, while seated in a quiet room.
| Study group | Role | What they receive |
|---|---|---|
| No Component | No intervention | Participants receive none of the three components and do not attend Zoom sessions. They complete a daily affect rating by emailed survey and a weekly safety survey. |
| Writing Only | Experimental | Participants complete emotional well-being writing in each of 20 live Zoom sessions over 4 weeks. Receives: Behavioral: Emotional Well-Being Writing |
| Squats Only | Experimental | Participants complete chair-assisted squats in each of 20 live Zoom sessions over 4 weeks. Receives: Behavioral: Chair-Assisted Squats |
| Breathing Only | Experimental | Participants complete slow-paced breathing in each of 20 live Zoom sessions over 4 weeks. Receives: Behavioral: Slow-Paced Breathing |
| Writing and Squats | Experimental | Participants complete chair-assisted squats and then emotional well-being writing in each of 20 live Zoom sessions over 4 weeks. Receives: Behavioral: Emotional Well-Being Writing; Behavioral: Chair-Assisted Squats |
| Writing and Breathing | Experimental | Participants complete slow-paced breathing and then emotional well-being writing in each of 20 live Zoom sessions over 4 weeks. Receives: Behavioral: Emotional Well-Being Writing; Behavioral: Slow-Paced Breathing |
| Squats and Breathing | Experimental | Participants complete chair-assisted squats and then slow-paced breathing in each of 20 live Zoom sessions over 4 weeks. Receives: Behavioral: Chair-Assisted Squats; Behavioral: Slow-Paced Breathing |
| Writing, Squats, and Breathing | Experimental | Participants complete chair-assisted squats, slow-paced breathing, and emotional well-being writing, in that order, in each of 20 live Zoom sessions over 4 weeks. Receives: Behavioral: Emotional Well-Being Writing; Behavioral: Chair-Assisted Squats; Behavioral: Slow-Paced Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Seated resting systolic blood pressure in mmHg, measured beat-to-beat with a finger and arm cuff device and averaged over a 5-minute recording.
Measured: Post-intervention visit, at the end of the 4-week intervention
Diastolic Blood Pressure
Seated resting diastolic blood pressure in mmHg, measured beat-to-beat with a finger and arm cuff device and averaged over a 5-minute recording.
Measured: Post-intervention visit, at the end of the 4-week intervention
Heart Rate
Seated resting heart rate in beats per minute, derived from a 5-minute three-lead electrocardiogram recording.
Measured: Post-intervention visit, at the end of the 4-week intervention
Heart Rate Variability
High-frequency heart rate variability, defined as natural-log-transformed spectral power in the 0.15 to 0.40 Hz band (ln ms2), derived from a 5-minute seated three-lead electrocardiogram recording. Higher values indicate greater vagally mediated heart rate variability.
Measured: Post-intervention visit, at the end of the 4-week intervention
Secondary outcomes (8)
Positive Affect (PANAS)
Positive affect subscale of the Positive and Negative Affect Schedule. Scores range from 10 to 50. Higher scores indicate more positive affect.
Measured: Post-intervention visit, at the end of the 4-week intervention
Negative Affect (PANAS)
Negative affect subscale of the Positive and Negative Affect Schedule. Scores range from 10 to 50. Higher scores indicate more negative affect.
Measured: Post-intervention visit, at the end of the 4-week intervention
Perceived Stress (PSS)
Perceived Stress Scale, 10 items. Scores range from 0 to 40. Higher scores indicate more perceived stress.
Measured: Post-intervention visit, at the end of the 4-week intervention
Secure Flourish Index
Secure Flourish Index, 12 items across 6 domains. Each item is rated from 0 to 10 and the items are averaged, so scores range from 0 to 10. Higher scores indicate greater flourishing.
Measured: Post-intervention visit, at the end of the 4-week intervention
Difficulties in Emotion Regulation (DERS-SF)
Difficulties in Emotion Regulation Scale Short Form, 18 items. Scores range from 18 to 90. Higher scores indicate greater difficulty regulating emotion.
Measured: Post-intervention visit, at the end of the 4-week intervention
Optimism (LOT-R)
Life Orientation Test-Revised, 6 scored items. Scores range from 0 to 24. Higher scores indicate greater optimism.
Measured: Post-intervention visit, at the end of the 4-week intervention
Affect Valence
Affect valence item from the end-of-study survey, rated from 1 to 9. A rating of 1 means completely happy, pleased, satisfied, content, and hopeful; a rating of 9 means completely unhappy, annoyed, unsatisfied, melancholic, despaired, and bored. The scale runs in the reverse of the usual direction: a higher score indicates more unpleasant affect. This item is distinct from the Feeling Scale used for in-session affective response.
Measured: End of each intervention week (weeks 1, 2, 3, and 4) and post-intervention visit
Affect Arousal
Affect arousal item from the end-of-study survey, rated from 1 to 9. A rating of 1 means completely stimulated, excited, frenzied, jittery, wide-awake, and aroused; a rating of 9 means completely relaxed, calm, sluggish, dull, sleepy, and unaroused. The scale runs in the reverse of the usual direction: a higher score indicates lower arousal. This item is distinct from the Feeling Scale used for in-session affective response.
Measured: End of each intervention week (weeks 1, 2, 3, and 4) and post-intervention visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start14 Nov 2025
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional Well-beingStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2x2 full factorial design. Each of three components (writing, squats, breathing) is set to on or off, giving eight conditions.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harold Lee, Penn State University
- Investigators
- Harold H Lee, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862478
- Sponsor's protocol ID
- STUDY00026780
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Action: The Impact of Emotional WellBeing Intervention in Increasing Optimism and Biological Markers
- ClinicalTrials.gov ID
- NCT07862478
- Acronym / sponsor ID
- STUDY00026780
- Keywords
- multiphase optimization strategy, factorial design, slow-paced breathing;, chair-assisted squats, writing intervention, optimism, heart rate variability, affective response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 7 Oct 2026 (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 pilot study tests whether three brief mind-body activities can be delivered remotely to midlife adults, and whether they show early signs of improving cardiovascular health, emotional well-being, and stress. The activities are an emotional well-being writing exercise, two minutes of chair-assisted squats, and five minutes of slow-paced breathing. Insufficiently active adults aged 40 to 65 years are randomly assigned to one of eight groups. The groups cover every combination of the three activities, including one group that receives none. Participants complete their assigned activities in live Zoom sessions with a research assistant on five weekdays per week for four weeks (20 sessions). Blood pressure, heart rate, heart rate variability, a small blood sample, and questionnaires on emotional well-being and stress are collected at in-person visits before and after the four weeks. Participants also rate how they feel immediately before and during each activity.
Detailed description
This is a pilot randomized trial with a 2x2x2 full factorial design, conducted in the preparation phase of the multiphase optimization strategy (MOST). Three intervention components are each set to on or off: emotional well-being writing, chair-assisted squats, and slow-paced breathing. Crossing the three factors gives eight conditions, including a condition in which no component is delivered.
The study has two aims. Aim 1 is to assess the feasibility and acceptability of the factorial trial, including recruitment, retention, delivery of the components, adherence, and collection of biobehavioral measures. Aim 2 is to explore the preliminary effects of the components on cardiovascular measures, emotional well-being, and psychological stress.
All participants complete an in-person baseline visit that includes capillary blood collection, self-report questionnaires, and a 5-minute seated recording of beat-to-beat blood pressure and electrocardiography. Participants are then randomized. Those assigned to at least one component attend live Zoom sessions with a trained research assistant on 5 weekdays per week for 4 weeks (20 sessions of up to 30 minutes). Assigned components are delivered in a fixed order of squats, breathing, and writing. Participants assigned to no component do not attend Zoom sessions. They complete a daily affect rating by emailed survey and a weekly safety survey. All participants return for an in-person post-intervention visit with the same measures and a feasibility questionnaire.
Affective response to each component is measured in every session with the Feeling Scale, a single item rated from -5 (very bad) to +5 (very good). Research assistants ask the item aloud immediately before each component and once during it, at minute 1 of squats, minute 2 of breathing, and minute 5 of writing.
The protocol allowed enrollment of up to 80 participants. Forty-three participants were enrolled between November 2025 and May 2026, and the last post-intervention visit took place in June 2026. This record was registered after data collection was complete. Outcome measures are listed as specified in the protocol approved by the institutional review board.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- 2x2x2 full factorial design. Each of three components (writing, squats, breathing) is set to on or off, giving eight conditions.
| Arm | Type | Receives |
|---|---|---|
| No Component | No intervention | –Participants receive none of the three components and do not attend Zoom sessions. They complete a daily affect rating by emailed survey and a weekly safety survey. |
| Writing Only | Experimental | Behavioral: Emotional Well-Being WritingParticipants complete emotional well-being writing in each of 20 live Zoom sessions over 4 weeks. |
| Squats Only | Experimental | Behavioral: Chair-Assisted SquatsParticipants complete chair-assisted squats in each of 20 live Zoom sessions over 4 weeks. |
| Breathing Only | Experimental | Behavioral: Slow-Paced BreathingParticipants complete slow-paced breathing in each of 20 live Zoom sessions over 4 weeks. |
| Writing and Squats | Experimental | Behavioral: Emotional Well-Being Writing, Behavioral: Chair-Assisted SquatsParticipants complete chair-assisted squats and then emotional well-being writing in each of 20 live Zoom sessions over 4 weeks. |
| Writing and Breathing | Experimental | Behavioral: Emotional Well-Being Writing, Behavioral: Slow-Paced BreathingParticipants complete slow-paced breathing and then emotional well-being writing in each of 20 live Zoom sessions over 4 weeks. |
| Squats and Breathing | Experimental | Behavioral: Chair-Assisted Squats, Behavioral: Slow-Paced BreathingParticipants complete chair-assisted squats and then slow-paced breathing in each of 20 live Zoom sessions over 4 weeks. |
| Writing, Squats, and Breathing | Experimental | Behavioral: Emotional Well-Being Writing, Behavioral: Chair-Assisted Squats, Behavioral: Slow-Paced BreathingParticipants complete chair-assisted squats, slow-paced breathing, and emotional well-being writing, in that order, in each of 20 live Zoom sessions over 4 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 40 to 65 years
- Able to read and write in English
- Sedentary lifestyle, defined as fewer than 150 minutes per week of moderate-intensity physical activity and no structured exercise regimen in the past 6 months
- Access to a computer or laptop and stable internet for Zoom sessions
- Able to rise from a standard chair to standing without physical assistance and lower back into the chair in a controlled manner
Key exclusion criteria (5 listed)
- Cardiovascular or respiratory disease
- Symptoms of major disease
- Systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher without antihypertensive medication
- Musculoskeletal limitations that impair squat performance
- Surgical procedure within the past 6 months
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 |
|---|---|---|
| Emotional Well-Being WritingA structured writing exercise of 10 to 15 minutes, completed in an online workbook during each live Zoom session on 5 weekdays per week for 4 weeks (20 sessions). Sessions 1 to 12 used forgiveness-focused prompts. Sessions 13 to 20 used positive psychology prompts, including gratitude, personal strengths, and best possible self. Research assistants did not give feedback on writing content. | Behavioural | Writing Only, Writing and Breathing, Writing and Squats, Writing, Squats, and Breathing |
| Chair-Assisted SquatsTwo minutes of chair-assisted squats in each live Zoom session on 5 weekdays per week for 4 weeks (20 sessions), supervised by a research assistant. Participants aimed for about 80 percent of the repetitions they completed in a supervised 2-minute baseline test, which was stopped with about three repetitions in reserve. A chair without wheels was placed behind the participant. Participants could stop or switch to marching in place at any time. | Behavioural | Squats Only, Squats and Breathing, Writing and Squats, Writing, Squats, and Breathing |
| Slow-Paced BreathingFive minutes of paced breathing at 6 breaths per minute in each live Zoom session on 5 weekdays per week for 4 weeks (20 sessions). Participants followed an on-screen visual pacer (EZ-Air), inhaling through the nose as a ball rose and exhaling through pursed lips as it fell, while seated in a quiet room. | Behavioural | Breathing Only, Squats and Breathing, Writing and Breathing, Writing, Squats, and Breathing |
Primary outcome
Systolic Blood Pressure
Time frame: Post-intervention visit, at the end of the 4-week intervention
Seated resting systolic blood pressure in mmHg, measured beat-to-beat with a finger and arm cuff device and averaged over a 5-minute recording.
Diastolic Blood Pressure
Time frame: Post-intervention visit, at the end of the 4-week intervention
Seated resting diastolic blood pressure in mmHg, measured beat-to-beat with a finger and arm cuff device and averaged over a 5-minute recording.
Heart Rate
Time frame: Post-intervention visit, at the end of the 4-week intervention
Seated resting heart rate in beats per minute, derived from a 5-minute three-lead electrocardiogram recording.
Heart Rate Variability
Time frame: Post-intervention visit, at the end of the 4-week intervention
High-frequency heart rate variability, defined as natural-log-transformed spectral power in the 0.15 to 0.40 Hz band (ln ms2), derived from a 5-minute seated three-lead electrocardiogram recording. Higher values indicate greater vagally mediated heart rate variability.
8 secondary outcomes
Positive Affect (PANAS)
Time frame: Post-intervention visit, at the end of the 4-week intervention
Negative Affect (PANAS)
Time frame: Post-intervention visit, at the end of the 4-week intervention
Perceived Stress (PSS)
Time frame: Post-intervention visit, at the end of the 4-week intervention
Secure Flourish Index
Time frame: Post-intervention visit, at the end of the 4-week intervention
Difficulties in Emotion Regulation (DERS-SF)
Time frame: Post-intervention visit, at the end of the 4-week intervention
Optimism (LOT-R)
Time frame: Post-intervention visit, at the end of the 4-week intervention
Affect Valence
Time frame: End of each intervention week (weeks 1, 2, 3, and 4) and post-intervention visit
Affect Arousal
Time frame: End of each intervention week (weeks 1, 2, 3, and 4) and post-intervention visit
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 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Emotional Well-being
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
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.
Harold H Lee, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Well-Being Writing, Chair-Assisted Squats and Slow-Paced Breathing in people with Emotional Well-being and Psychological Stress, run by Penn State University 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 8 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 7 Oct 2026. 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?
Systolic Blood Pressure (time frame: Post-intervention visit, at the end of the 4-week intervention). 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?
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 7 Oct 2026.