An interventional study of Emotional Well-Being Writing and Chair-Assisted Squats in Emotional Well-being, Psychological Stress and Cardiovascular Risk, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Penn State University · Not applicable, Interventional, and Basic science
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.
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.
806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.
This study's enrollment of 43 is below the median of 84 across 651 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Penn State University is the lead sponsor of 269 studies on the registry; 52 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
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Exclusion Criteria:
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.
Participants complete emotional well-being writing in each of 20 live Zoom sessions over 4 weeks.
Behavioral: Emotional Well-Being Writing
Participants complete chair-assisted squats in each of 20 live Zoom sessions over 4 weeks.
Behavioral: Chair-Assisted Squats
Participants complete slow-paced breathing in each of 20 live Zoom sessions over 4 weeks.
Behavioral: Slow-Paced Breathing
Participants complete chair-assisted squats and then emotional well-being writing in each of 20 live Zoom sessions over 4 weeks.
Behavioral: Emotional Well-Being Writing · Behavioral: Chair-Assisted Squats
Participants complete slow-paced breathing and then emotional well-being writing in each of 20 live Zoom sessions over 4 weeks.
Behavioral: Emotional Well-Being Writing · Behavioral: Slow-Paced Breathing
Participants complete chair-assisted squats and then slow-paced breathing in each of 20 live Zoom sessions over 4 weeks.
Behavioral: Chair-Assisted Squats · Behavioral: Slow-Paced Breathing
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.
Behavioral: Emotional Well-Being Writing · Behavioral: Chair-Assisted Squats · Behavioral: Slow-Paced Breathing
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-intervention visit, at the end of the 4-week intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of each intervention week (weeks 1, 2, 3, and 4) and post-intervention visit
In-Session Affective Response to Each Component (Feeling Scale)
Change in the Feeling Scale rating from immediately before a component to during it (minute 1 of squats, minute 2 of breathing, minute 5 of writing). The Feeling Scale is a single item rated from -5 (very bad) to +5 (very good). Change scores range from -10 to +10. Negative values indicate that the participant felt worse during the component.
Time frame: Each of 20 intervention sessions over 4 weeks
Retention
Percentage of randomized participants who complete the post-intervention visit.
Time frame: Post-intervention visit, at the end of the 4-week intervention
Session Attendance
Percentage of scheduled Zoom sessions attended, among participants assigned to at least one component.
Time frame: 20 intervention sessions over 4 weeks
Acceptability
Overall study experience rated on a feasibility questionnaire item from 1 to 5. Higher scores indicate a better experience.
Time frame: Session 20, at the end of the 4-week intervention
C-Reactive Protein
Plasma C-reactive protein concentration from a capillary blood sample.
Time frame: Post-intervention visit, at the end of the 4-week intervention
Interleukin-6
Plasma interleukin-6 concentration from a capillary blood sample.
Time frame: Post-intervention visit, at the end of the 4-week intervention
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2025 to primary completion in Jun 2026, 7 months.
Of 444 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 7 months is below that.
Counting every sponsor, half of 456 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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