The Impact of Yoga-based Physical Therapy for Individuals With Traumatic Brain Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 10/12/2018 |
| Start Date: | October 1, 2018 |
| End Date: | October 1, 2019 |
| Contact: | Kelly Krese, DPT |
| Email: | kkrese@sralab.org |
| Phone: | 312-238-5938 |
The Impact of Yoga-based Physical Therapy on Heart Rate Variability for Individuals With Traumatic Brain Injury: a Pilot Study
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.
(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.
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.
Inclusion Criteria:
- Individuals diagnosed with traumatic brain injury admitted to the Shirley Ryan
AbilityLab (SRALab)
- Age 18 or older
- Able and willing to give written consent or has an identified medical proxy willing to
give written consent on behalf of the individual
- Able to follow commands consistently with a reasonable amount of verbal or visual cues
in order to participate in a 60-minute physical therapy session in a group setting
- Able to attend to a task with reasonable amount of verbal or visual cues in order to
participate in a 60-minute physical therapy session in a group setting
- Behaviorally appropriate for a group setting in terms of verbal or physical
escalation/aggression
Exclusion Criteria:
- Serious cardiac conditions (arrhythmias) or neurological comorbidities (such as
multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
- Pregnant or nursing
- Skin allergies or irritation; open wounds in the areas that the sensors would be
applied to
- Utilizing a powered, implanted cardiac device for monitoring or supporting heart
function (i.e. pacemaker, defibrillator, or LVAD)
- Non-English speaking patients, due to necessity for an interpreter to be present
constantly interpreting, which could impact the low-stimulation setting of the
intervention
- Aphasia or any difficulties in accurately self-reporting
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