Trial Outcomes & Findings for Yoga and Female Concussion (NCT NCT07170488)
NCT ID: NCT07170488
Last Updated: 2025-12-10
Results Overview
Post Traumatic Growth Inventory (PTGI-X). Scores range from 0-125, with higher scores indicating greater post traumatic growth. Scores ≥75 is used as cutoff for moderate to high PTG; and scores \<75 are deemed low PTG
COMPLETED
NA
27 participants
Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)
2025-12-10
Participant Flow
Participant milestones
| Measure |
Yoga Group
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
15
|
|
Overall Study
COMPLETED
|
5
|
11
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Yoga and Female Concussion
Baseline characteristics by cohort
| Measure |
Yoga Group
n=12 Participants
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
n=15 Participants
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 Years
n=4 Participants
|
35.8 Years
n=50 Participants
|
40.8 Years
n=681 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=4 Participants
|
15 Participants
n=50 Participants
|
27 Participants
n=681 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=4 Participants
|
10 Participants
n=50 Participants
|
20 Participants
n=681 Participants
|
|
Race/Ethnicity, Customized
Black/AA
|
1 Participants
n=4 Participants
|
5 Participants
n=50 Participants
|
6 Participants
n=681 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=681 Participants
|
PRIMARY outcome
Timeframe: Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)Population: Response rate at week 19 was much lower than earlier timepoints, leading to a smaller size. We completed the analyses for those without missing data.
Post Traumatic Growth Inventory (PTGI-X). Scores range from 0-125, with higher scores indicating greater post traumatic growth. Scores ≥75 is used as cutoff for moderate to high PTG; and scores \<75 are deemed low PTG
Outcome measures
| Measure |
Yoga Group
n=5 Participants
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
n=11 Participants
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
|---|---|---|
|
Post Traumatic Growth
Week 19 (after the wait-list control group had completed their yoga sessions)
|
37.6 Score on a scale
Interval 0.0 to 48.0
|
71.5 Score on a scale
Interval 22.0 to 112.0
|
|
Post Traumatic Growth
Baseline (at enrollment)
|
41.7 Score on a scale
Interval 14.0 to 59.0
|
57.8 Score on a scale
Interval 40.0 to 73.0
|
|
Post Traumatic Growth
1 week post-yoga (Week 7)
|
40.4 Score on a scale
Interval 1.0 to 61.0
|
60.7 Score on a scale
Interval 13.0 to 120.0
|
|
Post Traumatic Growth
4 weeks post-yoga (Week 10)
|
32.5 Score on a scale
Interval 0.0 to 39.0
|
11 Score on a scale
Interval 3.0 to 113.0
|
SECONDARY outcome
Timeframe: Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)Population: Response rate at week 19 was much lower than earlier timepoints, leading to a smaller size. We completed the analyses for those without missing data.
To assess intimacy/relationships after brain injury. Consists of 6 questions related to sexual activity within the 4 weeks prior to the examination and includes sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain. Scoring is based on Likert scoring from 0-5. Total scores range from 2-30 with lower scores corresponding to worse sexual functioning.
Outcome measures
| Measure |
Yoga Group
n=5 Participants
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
n=11 Participants
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
|---|---|---|
|
Female Sexual Function Index-6 (FSFI-6)
Baseline (at enrollment)
|
11 Score on a scale
Interval 0.0 to 26.0
|
19.15 Score on a scale
Interval 0.0 to 28.0
|
|
Female Sexual Function Index-6 (FSFI-6)
1 week post-yoga (Week 7)
|
17.5 Score on a scale
Interval 0.0 to 27.0
|
20.18 Score on a scale
Interval 8.0 to 27.0
|
|
Female Sexual Function Index-6 (FSFI-6)
4 weeks post-yoga (Week 10)
|
16.75 Score on a scale
Interval 0.0 to 28.0
|
19.27 Score on a scale
Interval 8.0 to 29.0
|
|
Female Sexual Function Index-6 (FSFI-6)
Week 19 (after the wait-list control group had completed their yoga sessions)
|
12.2 Score on a scale
Interval 0.0 to 19.0
|
23 Score on a scale
Interval 19.0 to 27.0
|
SECONDARY outcome
Timeframe: Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)Population: Response rate at week 19 was much lower than earlier timepoints, leading to a smaller size. We completed the analyses for those without missing data.
Resilience will be measured using the 25-item Resilience Scale. Range of scores: 25 - 175; higher scores indicating greater resilience
Outcome measures
| Measure |
Yoga Group
n=5 Participants
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
n=11 Participants
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
|---|---|---|
|
Resilience
1 week post-yoga (Week 7)
|
133.1 Score on a scale
Interval 102.0 to 158.0
|
142.4 Score on a scale
Interval 117.0 to 169.0
|
|
Resilience
4 weeks post-yoga (Week 10)
|
133.9 Score on a scale
Interval 109.0 to 149.0
|
140.2 Score on a scale
Interval 118.0 to 157.0
|
|
Resilience
Week 19 (after the wait-list control group had completed their yoga sessions)
|
127.3 Score on a scale
Interval 106.0 to 131.0
|
143.3 Score on a scale
Interval 124.0 to 154.0
|
|
Resilience
Baseline (at enrollment)
|
133.6 Score on a scale
Interval 100.0 to 160.0
|
134.9 Score on a scale
Interval 107.0 to 154.0
|
SECONDARY outcome
Timeframe: Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)Population: Response rate at week 19 was much lower than earlier timepoints, leading to a smaller size. We completed the analyses for those without missing data.
This 12- item scale will be used to understand overall wellbeing before and after the intervention. The score is obtained by summing the scores from the twelve questions in all six domains and results in a score from 0 - 120. Scores are on a scale of 0-10. Higher scores are indicative of greater flourishing.
Outcome measures
| Measure |
Yoga Group
n=5 Participants
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
n=11 Participants
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
|---|---|---|
|
Flourishing
Baseline (at enrollment)
|
72.3 Score on a scale
Interval 32.0 to 100.0
|
84.1 Score on a scale
Interval 63.0 to 103.0
|
|
Flourishing
1 week post-yoga (Week 7)
|
75.3 Score on a scale
Interval 36.0 to 94.0
|
59 Score on a scale
Interval 59.0 to 107.0
|
|
Flourishing
4 weeks post-yoga (Week 10)
|
73.8 Score on a scale
Interval 56.0 to 88.0
|
90.5 Score on a scale
Interval 74.0 to 110.0
|
|
Flourishing
Week 19 (after the wait-list control group had completed their yoga sessions)
|
68.7 Score on a scale
Interval 43.0 to 79.0
|
92.5 Score on a scale
Interval 72.0 to 105.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)Population: Response rate at week 19 was much lower than earlier timepoints, leading to a smaller size. We completed the analyses for those without missing data.
The investigators will use the Rivermead Post-Concussion Questionnaire to evaluate prevalence of persistent Post-concussion Symptoms among study participants. The RPQ is a 16-item self-report measure of the presence and severity of the 16 most commonly reported post-concussive symptoms observed in the literature. Values for each of the 16 items are ranked on a five-point scale (0 = not experienced at all, 4 = severe problem). Scores on the RPQ range from 0 to 64, with higher scores suggestive of greater PCS burden.
Outcome measures
| Measure |
Yoga Group
n=5 Participants
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
n=11 Participants
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
|---|---|---|
|
Rivermead Post-Concussion Questionnaire
Baseline (at enrollment)
|
35.4 Score on a scale
Interval 28.0 to 45.0
|
26 Score on a scale
Interval 1.0 to 44.0
|
|
Rivermead Post-Concussion Questionnaire
1 week post-yoga (Week 7)
|
35.7 Score on a scale
Interval 26.0 to 46.0
|
25 Score on a scale
Interval 1.0 to 37.0
|
|
Rivermead Post-Concussion Questionnaire
4 weeks post-yoga (Week 10)
|
36 Score on a scale
Interval 24.0 to 52.0
|
11 Score on a scale
Interval 0.0 to 40.0
|
|
Rivermead Post-Concussion Questionnaire
Week 19 (after the wait-list control group had completed their yoga sessions)
|
34.3 Score on a scale
Interval 24.0 to 48.0
|
18.3 Score on a scale
Interval 1.0 to 27.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)Population: Response rate at week 19 was much lower than earlier timepoints, leading to a smaller size. We completed the analyses for those without missing data.
The investigators will use the General Anxiety Disorder (GAD-7) to evaluate prevalence of anxiety post-concussion using this brief 9-item screener. Participants respond to how often they have been bothered by symptoms, from 0 (not at all) to 3 (nearly every day).GAD-7 total score for the seven items ranges from 0 to 21, with higher scores suggestive of greater anxiety.
Outcome measures
| Measure |
Yoga Group
n=5 Participants
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
n=11 Participants
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
|---|---|---|
|
Anxiety
Baseline (at enrollment)
|
7.7 Score on a scale
Interval 1.0 to 9.0
|
7.3 Score on a scale
Interval 3.0 to 11.0
|
|
Anxiety
1 week post-yoga (Week 7)
|
3.8 Score on a scale
Interval 1.0 to 8.0
|
4.8 Score on a scale
Interval 1.0 to 12.0
|
|
Anxiety
4 weeks post-yoga (Week 10)
|
6.4 Score on a scale
Interval 0.0 to 12.0
|
6.3 Score on a scale
Interval 1.0 to 15.0
|
|
Anxiety
Week 19 (after the wait-list control group had completed their yoga sessions)
|
8.3 Score on a scale
Interval 2.0 to 13.0
|
8 Score on a scale
Interval 2.0 to 11.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)Population: Response rate at week 19 was much lower than earlier timepoints, leading to a smaller size. We completed the analyses for those without missing data.
The investigators will use the Patient Health Questionnaire (PHQ-9) to evaluate prevalence of depression post-concussion among study participants. The Patient Health Questionnaire (PHQ-9) is a 9-item screener to assess the frequency of depressed mood/anhedonia over the past two weeks. Participants respond to how often they have been bothered by symptoms, from 0 (not at all) to 3 (nearly every day). Scores range from 0-27, with higher scores suggestive of greater depression.
Outcome measures
| Measure |
Yoga Group
n=5 Participants
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
n=11 Participants
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
|---|---|---|
|
Depression
Baseline (at enrollment)
|
9.5 Score on a scale
Interval 5.0 to 16.0
|
9.2 Score on a scale
Interval 1.0 to 17.0
|
|
Depression
1 week post-yoga (Week 7)
|
7.6 Score on a scale
Interval 4.0 to 17.0
|
7.4 Score on a scale
Interval 2.0 to 19.0
|
|
Depression
4 weeks post-yoga (Week 10)
|
9 Score on a scale
Interval 3.0 to 16.0
|
8.2 Score on a scale
Interval 0.0 to 16.0
|
|
Depression
Week 19 (after the wait-list control group had completed their yoga sessions)
|
9.6 Score on a scale
Interval 3.0 to 17.0
|
8.8 Score on a scale
Interval 0.0 to 14.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)Population: Response rate at week 19 was much lower than earlier timepoints, leading to a smaller size. We completed the analyses for those without missing data.
The investigators will use the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) (PCL-5) to evaluate prevalence of PTSD among study participants. This is a well-validated 20-item scale that assesses symptoms mirrored from the diagnostic criteria for PTSD in the DSM-V. Participants rate the extent that symptoms have bothered them in the past month on a 5-point scale from 0-4, with total scores ranging from 0-80 and higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Yoga Group
n=5 Participants
The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week
|
Wait List Control Group
n=11 Participants
This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.
|
|---|---|---|
|
Post Traumatic Stress Disorder (PTSD)
1 week post-yoga (Week 7)
|
19.2 Score on a scale
Interval 2.0 to 47.0
|
22.2 Score on a scale
Interval 0.0 to 51.0
|
|
Post Traumatic Stress Disorder (PTSD)
Baseline (at enrollment)
|
28.2 Score on a scale
Interval 5.0 to 68.0
|
26.7 Score on a scale
Interval 4.0 to 60.0
|
|
Post Traumatic Stress Disorder (PTSD)
4 weeks post-yoga (Week 10)
|
23.4 Score on a scale
Interval 3.0 to 52.0
|
26.2 Score on a scale
Interval 2.0 to 60.0
|
|
Post Traumatic Stress Disorder (PTSD)
Week 19 (after the wait-list control group had completed their yoga sessions)
|
28.3 Score on a scale
Interval 2.0 to 57.0
|
28.5 Score on a scale
Interval 0.0 to 41.0
|
Adverse Events
Yoga Group
Wait List Control Group
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