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This study aims to explore if a yoga-based physical therapy session would promote improved (increased) heart rate variability in subjects with traumatic brain injuries. The results of this pilot study may inform a larger-scale study of the effects of regular participation in a yoga-based program as an adjunct to traditional physical therapy. The secondary objective is to determine whether a yoga-based physical therapy session would impact anxiety, fatigue, or agitation and/or sleep quality. The study will enroll up to 30 inpatient subjects on a rolling basis as they are admitted with traumatic brain injury over a 12 month period at the Shirley Ryan AbilityLab.
Each person in the study will participate in three conditions in a random order across three days: 1 hour of yoga-based physical therapy session in a group setting,1 hour of one-on-one conventional physical therapy, and 1 hour of seated rest in a relaxing environment in a group setting.
The hypothesis is that individuals who participate in 1 hour of a yoga-based physical therapy session in a group setting will demonstrate a significant improvement in heart rate variability, anxiety, fatigue, and agitation after the session when compared to the same measures after 1 hour of a conventional physical therapy session and 1 hour of seated rest in a relaxing environment. Sleep will also be assessed with an activity monitor.
Admissions to the traumatic brain injury service of Shirley Ryan AbilityLab will be reviewed on a weekly basis, and eligible patients will be approached to attain assent/consent. Patients will be randomized as to which condition they participate in first. Subjects will be instructed not to eat or drink caffeine within 1 hour of participating in a condition. A trained researcher will apply three sensors to the chest. The sensors to monitor heart rate variability (HRV) via electrocardiogram (EKG) are from the BioStampRC Discovery Kit MC10, Inc., and are research-grade, non-invasive, wireless, wearable sensors. For each sensor location, the skin will be prepped and cleaned using alcohol wipes. Sensors are placed on the skin using adhesive stickers that minimize irritation. Medical dressing (Tegaderm, 3M) may also be used to ensure adhesion and proper contact with the skin. Sensors will be cleaned with soap and water before and after use. Vital signs will be measured. The self-reported outcome measures will be administered by a blinded clinician.
The subject will participate in the assigned condition for that day as determined by randomization, and HRV will be monitored throughout the condition. Immediately following the 1-hour condition, the sensors will be removed by a trained researcher and the self-reported outcomes will again be administered under the supervision of a blinded clinician. Subjects will complete forms as able, but if they require physical assistance to fill out or verbal assistance in reading the questions, such assistance will be provided. Sleep quality will be captured by an activity monitor. Research staff will don and doff the activity monitors.
All sessions will be supervised by a physical therapist. Research staff will be responsible for all sensor recording practices, such as instrumenting the sensors and marking therapy activities on a computer tablet using the BioStampRC software. Research staff will also keep a written log of activities as they are undertaken during the assessments, including notable events, amount and type of assistance, or use of external devices. Logs will be consulted during analysis to compare with the timestamped sensor data.
Audio/video recording may be utilized in order to allow a registered yoga therapist to validate the yoga-based program led by the researcher-clinician physical therapist. The recordings would only be viewed by the physical therapist and registered yoga therapist, and destroyed after publication of the research. The videos would be stored in a password-protected device; the yoga therapist and physical therapist would be the only individuals with access.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga-based physical therapy group | Experimental | The yoga-based physical therapy session will take place in an enclosed, quiet space to minimize outside noise or distraction. The lights will be dimmed, and light, instrumental, calming music will be played throughout. The group will consist of approximately 2-5 individuals depending on the physical capabilities and assistance levels required. The session will consist of an introduction to pranayama (foundational breath-based exercises) followed by asanas, or physical postures, that will be modified according to each individual's physical abilities. The session will close with a 4-5 minute savasana performed in a supine or seated position pending patient physical abilities, which consists of progressive relaxation, guided meditation, and guided motor imagery. |
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| Seated rest | Active Comparator | Subjects will engage in 1 hour of seated rest in a relaxing environment in a group of approximately 2-5 individuals. This session will occur in the same enclosed, quiet space as condition A to minimize outside noise or distraction and to reproduce environment of condition A. The lights will be dimmed, and the same light, instrumental, calming music will be played throughout to contribute to a relaxing ambiance. Subjects will be instructed to rest quietly. |
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| Conventional Physical Therapy | Active Comparator | Subjects will engage in 1 hour of a conventional PT session (or "treatment as usual") led by a different physical therapist than who is leading the yoga-based session to minimize bias. There will be no restrictions on what can and cannot occur during conventional PT sessions in order to accurately represent and preserve the wide range of treatments that may occur during a physical therapy session in the inpatient setting. Examples of what may occur include, but are not limited to: gait, standing balance, functional mobility, or therapeutic exercise. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga-based physical therapy group | Other | All yoga-based sessions will be led by the same therapist to maximize between-session consistency. A trained researcher will also be present to provide additional cueing to subjects when required. The basic elements of the postures are similar to that of traditional physical therapy balance exercises. Cues will be provided throughout to pair appropriate breath cycles with appropriate postures consistent with a standard, able-bodied yoga program. The session will close with a 4-5 minute savasana performed in a supine or seated position pending patient physical abilities, which consists of progressive relaxation, guided meditation, and guided motor imagery. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | Heart rate variability will be measured by MC-10 sensors placed on the chest. | The sensors will be worn throughout the three 1 hour long conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Speilberger State-Trait Anxiety Inventory (STAI) - Short Form | This measure allows for assessment of self-reported present-state anxiety. It is a 6-question version of a longer original questionnaire that will aide in preventing cognitive fatigue that can sometimes be faced with longer surveys. Half the items corresponding to a "STAI-present" subscale (ie these 3 statements the person has to rate correspond with anxiety being present), while the other half of the items are part of a "STAI-absent" subscale (ie these 3 statements the person has to rate correspond with anxiety being absent). Subscale score ranges = 3-12. Higher STAI present scores = worse (more anxiety). Higher STAI absent scores = better (less anxiety). To calculate the TOTAL scale score (STAI absent and STAI present), the STAI-absent scores are inverted and added to the STAI-present scores; higher total scores indicate greater anxiety. Total score range: 6-24. Values reported below reflect changes in the scores after the intervention relative to before the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ripley, MD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32530717 | Derived | Krese K, Ingraham B, O'Brien MK, Mummidisetty CK, McNulty M, Srdanovic N, Kocherginsky M, Ripley D. The impact of a yoga-based physical therapy group for individuals with traumatic brain injury: results from a pilot study. Brain Inj. 2020 Jul 2;34(8):1118-1126. doi: 10.1080/02699052.2020.1776394. Epub 2020 Jun 12. |
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Yes.
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Two participants dropped out of the study after randomization but before they completed any of the interventions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Yoga-based Physical Therapy Group, Then Conventional Physical Therapy, Then Seated Rest | Participants completed a yoga-based physical therapy group for 1 hour, followed by conventional physical therapy for 1 hour the next day, followed by seated rest for 1 hour the next day (ie 3 consecutive days; no washout period). |
| FG001 | Yoga-based Physical Therapy, Seated Rest, Conventional Physical Therapy | Participants completed a yoga-based physical therapy group for 1 hour, followed by seated rest for 1 hour the next day, followed by conventional physical therapy for 1 hour the next day (ie 3 consecutive days; no washout period). |
| FG002 | Seated Rest, , Conventional Physical Therapy, Yoga-based Physical Therapy | Participants completed seated rest for 1 hour the next day, followed by conventional physical therapy for 1 hour the next day, followed by yoga-based physical therapy group for 1 hour (ie 3 consecutive days; no washout period). |
| FG003 | Seated Rest, Yoga-based Physical Therapy, Conventional Physical Therapy | Participants completed seated rest for 1 hour the next day, followed by yoga-based physical therapy group for 1 hour, followed by conventional physical therapy for 1 hour the next day (ie 3 consecutive days; no washout period). |
| FG004 | Conventional Physical Therapy, Seated Rest, Yoga-based Physical Therapy | Participants completed conventional physical therapy for 1 hour the next day, followed by seated rest for 1 hour the next day, followed by yoga-based physical therapy group for 1 hour (ie 3 consecutive days; no washout period). |
| FG005 | Conventional Physical Therapy, Yoga-based Physical Therapy, Seated Rest | Participants completed conventional physical therapy for 1 hour the next day, followed by yoga-based physical therapy group for 1 hour, followed by seated rest for 1 hour the next day (ie 3 consecutive days; no washout period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants were randomized to complete all interventions: seated rest, conventional physical therapy, and yoga-based physical therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Rate Variability | Heart rate variability will be measured by MC-10 sensors placed on the chest. | Posted | Median | Inter-Quartile Range | ms | The sensors will be worn throughout the three 1 hour long conditions. |
|
Over the course of study participation for each participant; since there was no follow-up, this time frame is approximately 1 week per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yoga-based Physical Therapy Group | The yoga-based physical therapy session will take place in an enclosed, quiet space to minimize outside noise or distraction. The group will consist of approximately 2-5 individuals. The session will consist of pranayama (foundational breath-based exercises) followed by asanas, or physical postures, that will be modified according to each individual's abilities. The session will close with a 4-5 minute savasana performed in a supine or seated position pending patient physical abilities, which consists of progressive relaxation, guided meditation, and guided motor imagery. The basic elements of the postures are similar to that of traditional physical therapy balance exercises. Cues will be provided throughout to pair appropriate breath cycles with appropriate postures consistent with a standard, able-bodied yoga program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Krese | Shirley Ryan AbilityLab | 6306992038 | kkrese@sralab.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2018 | May 14, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2018 | Jun 3, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The study will be a randomized, controlled, single-blinded, crossover design with three conditions: condition A will consist of 1 hour of yoga-based physical therapy session in a group setting; condition B will consist of 1 hour of one-on-one conventional physical therapy; condition C will consist of 1 hour of seated rest in a relaxing environment in a group setting.
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The people administering the self-reported outcome measures will be blinded to the condition the subject participated in.
|
|
| Seated Rest | Other | Subjects will engage in 1 hour of seated rest in a relaxing environment in a group of approximately 2-5 individuals. This session will occur in the same enclosed, quiet space as condition A to minimize outside noise or distraction and to reproduce environment of condition A. The lights will be dimmed, and the same light, instrumental, calming music will be played throughout to contribute to a relaxing ambiance. Subjects will be instructed to rest quietly. |
|
| Conventional Physical Therapy | Other | Subjects will engage in 1 hour of a conventional PT session (or "treatment as usual") led by a different physical therapist than who is leading the yoga-based session to minimize bias. There will be no restrictions on what can and cannot occur during conventional PT sessions in order to accurately represent and preserve the wide range of treatments that may occur during a physical therapy session in the inpatient setting. Examples of what may occur include, but are not limited to: gait, standing balance, functional mobility, or therapeutic exercise. |
|
| This measure will be administered before and after each condition (yoga, conventional PT, seated rest). STAI-present and STAI-absent subscales will be extracted as well as a total score. |
| Change in Global Fatigue Index-Modified | Score range: 3-15. A shortened version of the original global fatigue index utilizing only questions 1-3 will be utilized. The remaining questions were removed because they were not relevant to the inpatient setting. The question language was modified slightly to reflect present-state feelings (instead of feelings in the past week). The question response scale was modified to reflect a 1-5 rating instead of 1-10 to simplify given the severe cognitive deficits of the individuals in this study. Higher scores indicate greater fatigue (higher=worse). Values reported below reflect changes in the total score after the intervention relative to before the intervention. | This measure will be administered before and after each condition (yoga, conventional PT, seated rest). Data will be analyzed within approximately 10 months from enrollment of first participant, and research publication will be pursued. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time since injury (days) | Mean | Full Range | days |
|
| OG001 | Seated Rest | Subjects will engage in 1 hour of seated rest in a relaxing environment in a group of approximately 2-5 individuals. This session will occur in the same enclosed, quiet space as condition A to minimize outside noise or distraction and to reproduce environment of condition A. The lights will be dimmed, and the same light, instrumental, calming music will be played throughout to contribute to a relaxing ambiance. Subjects will be instructed to rest quietly. |
| OG002 | Conventional Physical Therapy | Subjects will engage in 1 hour of a conventional PT session (or "treatment as usual") led by a different physical therapist than who is leading the yoga-based session to minimize bias. There will be no restrictions on what can and cannot occur during conventional PT sessions in order to accurately represent and preserve the wide range of treatments that may occur during a physical therapy session in the inpatient setting. Examples of what may occur include, but are not limited to: gait, standing balance, functional mobility, or therapeutic exercise. |
|
|
|
| Secondary | Change in Speilberger State-Trait Anxiety Inventory (STAI) - Short Form | This measure allows for assessment of self-reported present-state anxiety. It is a 6-question version of a longer original questionnaire that will aide in preventing cognitive fatigue that can sometimes be faced with longer surveys. Half the items corresponding to a "STAI-present" subscale (ie these 3 statements the person has to rate correspond with anxiety being present), while the other half of the items are part of a "STAI-absent" subscale (ie these 3 statements the person has to rate correspond with anxiety being absent). Subscale score ranges = 3-12. Higher STAI present scores = worse (more anxiety). Higher STAI absent scores = better (less anxiety). To calculate the TOTAL scale score (STAI absent and STAI present), the STAI-absent scores are inverted and added to the STAI-present scores; higher total scores indicate greater anxiety. Total score range: 6-24. Values reported below reflect changes in the scores after the intervention relative to before the intervention. | Posted | Median | Inter-Quartile Range | Changes in scores pre vs post | This measure will be administered before and after each condition (yoga, conventional PT, seated rest). STAI-present and STAI-absent subscales will be extracted as well as a total score. |
|
|
|
| Secondary | Change in Global Fatigue Index-Modified | Score range: 3-15. A shortened version of the original global fatigue index utilizing only questions 1-3 will be utilized. The remaining questions were removed because they were not relevant to the inpatient setting. The question language was modified slightly to reflect present-state feelings (instead of feelings in the past week). The question response scale was modified to reflect a 1-5 rating instead of 1-10 to simplify given the severe cognitive deficits of the individuals in this study. Higher scores indicate greater fatigue (higher=worse). Values reported below reflect changes in the total score after the intervention relative to before the intervention. | Posted | Median | Inter-Quartile Range | Change of score pre to post | This measure will be administered before and after each condition (yoga, conventional PT, seated rest). Data will be analyzed within approximately 10 months from enrollment of first participant, and research publication will be pursued. |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Seated Rest | Subjects will engage in 1 hour of seated rest in a relaxing environment in a group of approximately 2-5 individuals. This session will occur in the same enclosed, quiet space as condition A to minimize outside noise or distraction and to reproduce environment of condition A. The lights will be dimmed, and the same light, instrumental, calming music will be played throughout to contribute to a relaxing ambiance. Subjects will be instructed to rest quietly. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Conventional Physical Therapy | Subjects will engage in 1 hour of a conventional PT session (or "treatment as usual") led by a different physical therapist than who is leading the yoga-based session to minimize bias. There will be no restrictions on what can and cannot occur during conventional PT sessions in order to accurately represent and preserve the wide range of treatments that may occur during a physical therapy session in the inpatient setting. Examples of what may occur include, but are not limited to: gait, standing balance, functional mobility, or therapeutic exercise. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
|
| Change in STAI absent subscale |
|