Trial Outcomes & Findings for The Impact of Yoga-based Physical Therapy for Individuals With Traumatic Brain Injury (NCT NCT03701594)
NCT ID: NCT03701594
Last Updated: 2026-06-04
Results Overview
Heart rate variability will be measured by MC-10 sensors placed on the chest.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
The sensors will be worn throughout the three 1 hour long conditions.
Results posted on
2026-06-04
Participant Flow
Two participants dropped out of the study after randomization but before they completed any of the interventions.
Participant milestones
| Measure |
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).
|
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).
|
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
1
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=11 Participants
All participants were randomized to complete all interventions: seated rest, conventional physical therapy, and yoga-based physical therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
|
Age, Continuous
|
45.31 years
STANDARD_DEVIATION 14.23 • n=11 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
|
Time since injury (days)
|
15 days
n=11 Participants
|
PRIMARY outcome
Timeframe: The sensors will be worn throughout the three 1 hour long conditions.Heart rate variability will be measured by MC-10 sensors placed on the chest.
Outcome measures
| Measure |
Yoga-based Physical Therapy Group
n=11 Participants
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.
|
Seated Rest
n=11 Participants
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
n=11 Participants
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.
|
|---|---|---|---|
|
Heart Rate Variability
|
21.29 ms
Interval 16.57 to 40.3
|
27.36 ms
Interval 12.31 to 42.13
|
18.49 ms
Interval 12.82 to 32.75
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Yoga-based Physical Therapy Group
n=11 Participants
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.
|
Seated Rest
n=11 Participants
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
n=11 Participants
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.
|
|---|---|---|---|
|
Change in Speilberger State-Trait Anxiety Inventory (STAI) - Short Form
Change in STAI total
|
0 Changes in scores pre vs post
Interval -3.0 to 0.0
|
-1.00 Changes in scores pre vs post
Interval -1.5 to 0.0
|
-1.50 Changes in scores pre vs post
Interval -2.25 to 0.0
|
|
Change in Speilberger State-Trait Anxiety Inventory (STAI) - Short Form
Change in STAI present subscale
|
-2.00 Changes in scores pre vs post
Interval -3.5 to 0.0
|
-1.00 Changes in scores pre vs post
Interval -3.0 to 0.0
|
-2.00 Changes in scores pre vs post
Interval -4.0 to 0.0
|
|
Change in Speilberger State-Trait Anxiety Inventory (STAI) - Short Form
Change in STAI absent subscale
|
0.00 Changes in scores pre vs post
Interval -2.0 to 0.0
|
0.00 Changes in scores pre vs post
Interval -1.0 to 0.0
|
-0.50 Changes in scores pre vs post
Interval -2.0 to 0.0
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Yoga-based Physical Therapy Group
n=11 Participants
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.
|
Seated Rest
n=11 Participants
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
n=11 Participants
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.
|
|---|---|---|---|
|
Change in Global Fatigue Index-Modified
|
0.00 Change of score pre to post
Interval -1.5 to 0.5
|
0.00 Change of score pre to post
Interval -1.0 to 0.0
|
0.50 Change of score pre to post
Interval 0.0 to 4.0
|
Adverse Events
Yoga-based Physical Therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Seated Rest
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Physical Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place