Traumatic Brain InjuryNCT03701594
The Impact of Yoga-based Physical Therapy for Individuals With Traumatic Brain Injury
A study testing Yoga-based physical therapy group, Seated Rest and Conventional Physical Therapy in people with Traumatic Brain Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Yoga-based physical therapy group, Seated Rest and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 1 Apr 2019
- Phase
- Interventional
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Yoga-based physical therapy group, Seated Rest, Conventional Physical Therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-based physical therapy groupOther
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.
Seated RestOther
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Yoga-based physical therapy group |
| 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. Receives: Other: Seated Rest |
| 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. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Heart rate variability will be measured by MC-10 sensors placed on the chest.
Measured: The sensors will be worn throughout the three 1 hour long conditions.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start22 Oct 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Krese, Shirley Ryan AbilityLab
- Investigators
- David Ripley, MD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701594
- Sponsor's protocol ID
- Yoga and HRV
- Status last verified
- Jun 2026
- First submitted
- 4 Oct 2018
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Yes.
Publications
Krese K, McNulty M, Justice C, Donnelly KZ. An Exploratory CFIR-Informed Process Evaluation Utilizing Data from a Pilot Randomized Controlled Trial of a Yoga-Based Physical Therapy Group Intervention in Inpatient Rehabilitation Following Traumatic Brain Injury. J Integr Complement Med. 2026 Jul 21:27683605261469660. doi: 10.1177/27683605261469660. Online ahead of print.
PubMed 42482430Krese 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.
PubMed 32530717