Acquired Brain InjuryRCTNCT05793827
Pilot Trial for Adults With Acquired Brain Injury
A study testing Adapted Hatha Yoga and Low-Impact Exercise in people with Acquired Brain Injury and Traumatic Brain Injury, run by Colorado State University at 1 site in United States.
Trial summary
This pilot study will compare a yoga program to a non-yoga exercise program in adults with brain injuries. The investigators will measure possible improvements in balance and heartrate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury, Traumatic Brain Injury, Stroke
- What is being tested?
- Adapted Hatha Yoga and Low-Impact Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sustained acquired brain injury at least 6 months prior
- Self-reported balance impairment of moderate or greater, via the Neurobehavioral Symptom Inventory
- Standard fMRI safety screening for MRI components only (participants can complete other study components if they are ineligible or unwilling to complete MRI)
Who cannot join
- Sustained acquired brain injury within past 6 months
- Self-reported mild balance impairment or no balance impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Medicine Institute
Fort Collins, Colorado, 80524
About this study
Official title: Evaluating Yoga Intervention-Induced Changes in Performance and Neurophysiology in Adults With Chronic Brain Injury
This pilot study will compare a yoga program to a non-yoga exercise program in adults with brain injuries. The investigators will measure possible improvements in balance and heartrate. The investigators also plan to measure changes in brain function and link balance and/or heartrate improvements to changes in brain function. Ideally, this work will create a foundation for a larger-scale study.
Read the detailed description
Background and Significance: Each year, an estimated 2.9 million Americans sustain brain injuries that result in emergency department visits, hospitalizations, and death. Although there are many treatment strategies in the early weeks and months after brain injury, millions of individuals live with residual disability. This residual, chronic disability often includes significant impairments and decreased brain function. Two prominent and interconnected impairments - poor balance and autonomic nervous system (ANS) dysfunction - can increase fall risk, decrease quality of life, and increase mortality. In adults with brain injury, ANS dysfunction is characterized by hyper-activation of the sympathetic nervous system, which can have damaging or even fatal impact on internal organs. To date, there are exceedingly few options for addressing these types of impairments or improving brain function in adults with chronic brain injury. However, community-based and holistic interventions, like hatha yoga, may be highly effective for simultaneously addressing balance and ANS impairments and may also improve brain function. Hatha yoga incorporates movements that improve balance, uses breathwork that may stabilize sympathetic and parasympathetic nervous system activity, can be adapted for individual needs, and has enhanced brain function in healthy adults. Despite this, there are few empirical studies investigating yoga for individuals with brain injury. To resolve this, the research team and investigator have conducted two yoga and brain injury feasibility studies and confirmed that recruitment, retainment, intervention, and neuroimaging procedures are feasible. In these studies, the investigators have found significant improvements in balance after yoga and preliminary evidence of improved brain function, even in the absence of measurable balance improvement. Finally, there is growing evidence that exercises, like yoga, can improve ANS function by regulating sympathetic and parasympathetic activity in healthy adults, suggesting significant potential for adults with chronic brain injury.
Project Objectives: Given feasibility study success and promising early findings. The investigators will conduct a pilot randomized control trial comparing 8-weeks of group yoga to 8-weeks of active control exercise in 48 adults with chronic brain injury. The investigators will test for improvements in balance and in ANS function using heart-rate variability (HRV) monitoring. The investigator will explore intervention-induced changes in brain function by evaluating intrinsic functional connectivity, using resting-state functional magnetic resonance imaging (rs-fMRI) and task-dependent neural activation, using a proxy of neural activity - oxygenated hemoglobin (HbO) - as measured with functional near-infrared spectroscopy (fNIRS) during concurrent balance tasks. Finally, if the investigators observe functional improvements in balance or ANS function and measurable changes in brain function, the investigator will then complete exploratory analyses to link functional improvements to changes in brain function.
- Conditions
- Acquired Brain Injury, Traumatic Brain Injury, Stroke
- Being tested
- Adapted Hatha Yoga, Low-Impact Exercise
- Keywords
- Yoga, Exercise, Balance, Autonomic Nervous System, Functional Near-Infrared Spectroscopy, Functional Magnetic Resonance Imaging
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Hatha YogaBehavioural
Yoga includes breath work (pranayama), gentle stretching and holding of postures (asanas), and meditation (dhyana). Modifications/adaptations are incorporated so all participants can successfully complete the yoga intervention. Yoga is delivered in a standardized progression, including: focused, slow breath with movement and breathwork throughout every session; mantras, progressively challenging yoga postures (sitting, standing, and floor); and meditation
Low-Impact ExerciseBehavioural
This includes low-intensity exercise, which is matched to the estimated metabolic costs of yoga, 2.5 Metabolic Equivalent of Task (MET). Sessions include warm up, cool down, and five, 10-minute exercise stations, (e.g., walking, balance, resistance bands, weight-bearing exercise, and core work). Control exercise will be prescribed between 2.0 to 3.0 METs, equating to 30 to 40% heart rate reserve. Heart rate zones are calculated for each participant and monitored to ensure proper intensity
| Study group | Role | What they receive |
|---|---|---|
| Adapted Hatha Yoga | Experimental | Not described Receives: Behavioral: Adapted Hatha Yoga |
| Low-Impact Exercise | Active comparator | Not described Receives: Behavioral: Low-Impact Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Standing Balance at 2 Months
Acquired using a force plate during simultaneous functional near-infrared spectroscopy
Measured: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months..
Change from Baseline in Autonomic Nervous System Function at 2 Months
Acquired via heart rate variability assessment using electrocardiography
Measured: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.
Change from Baseline in Functional Connectivity of Neural Networks at 2 Months
Acquired via resting state functional magnetic resonance imaging
Measured: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..
Change from Baseline in Task-Dependent Neural Activation at 2 Months
Acquired pre- and post-intervention via portable functional near-infrared spectroscopy during standing balance plates with force plate.
Measured: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..
Secondary outcomes (4)
Change from Baseline in Self-Reported Quality of Life at 2 Months
Acquired via the Traumatic Brain Injury Quality of Life Short Form Measure on NIH Toolbox app. The NIH toolbox manual does not provide a minimum or maximum score for this measure, nor does it support interpretation of the score. However, the NIH toolbox app uses the raw score from each participant and automatically converts it into a T-Score. A publication on this measure indicates (Tulsky et al. 2016) provides guidance on how to interpret T-scores, as the T-Score Mean is 50, with a Standard Deviation of 10. T-Scores above 50 indicate that individuals are having more problems in quality of life than age- and sex-matched individuals in the general population, whereas scores below 50 indicate that they are having fewer problems.
Measured: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..
Change from Baseline in Working Memory Performance at 2 Months
Acquired via the List Sorting Working Memory Test on the NIH Toolbox app. The NIH toolbox manual does not provide a minimum or maximum score for this measure, but score interpretations are more straightforward. The NIH toolbox app uses the raw score from each participant and automatically converts it into a T-Score, along with an age-scored standard score (higher indicates better performance) and an age-adjusted national percentile (0-100%), which shows how the participant compares to age- and sex-matched peers (higher also indicates better performance).
Measured: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months. .
Change from Baseline in Inhibitory Control at 2 Months
Acquired via the Flanker Inhibitory Test on the NIH Toolbox app. The NIH toolbox manual does not provide a minimum or maximum score for this measure, but score interpretations are more straightforward. The NIH toolbox app uses the raw score from each participant and automatically converts it into a T-Score, along with an age-scored standard score (higher indicates better performance) and an age-adjusted national percentile (0-100%), which shows how the participant compares to age- and sex-matched peers (higher also indicates better performance).
Measured: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.
Change from Baseline in Cognitive Flexibility at 2 Months
Acquired via the Dimensional Change Card Sort Test on the NIH Toolbox app. The NIH toolbox manual does not provide a minimum or maximum score for this measure, but score interpretations are more straightforward. The NIH toolbox app uses the raw score from each participant and automatically converts it into a T-Score, along with an age-scored standard score (higher indicates better performance) and an age-adjusted national percentile (0-100%), which shows how the participant compares to age- and sex-matched peers (higher also indicates better performance).
Measured: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start30 Jan 2023
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Boettcher Webb-Waring Biomedical Research Awards
- Responsible party
- Sponsor
- Investigators
- Jaclyn Stephens, PhD, OTR, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793827
- Sponsor's protocol ID
- 1799
- Acronym
- RCT
- Status last verified
- Jun 2024
- First submitted
- 13 Feb 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Ideally, we will upload de-identified participant data into a public repository. We are in the process of hiring and training personnel who can fulfill this role.
Publications
Stephens JA, Hernandez-Sarabia JA, Sharp JL, Leach HJ, Bell C, Thomas ML, Buryznska AZ, Weaver JA, Schmid AA. Adaptive yoga versus low-impact exercise for adults with chronic acquired brain injury: a pilot randomized control trial protocol. Front Hum Neurosci. 2023 Nov 23;17:1291094. doi: 10.3389/fnhum.2023.1291094. eCollection 2023.
PubMed 38077184
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Yoga Intervention-Induced Changes in Performance and Neurophysiology in Adults With Chronic Brain Injury
- ClinicalTrials.gov ID
- NCT05793827
- Acronym / sponsor ID
- RCT / 1799
- Conditions
- Acquired Brain Injury, Traumatic Brain Injury, Stroke
- Keywords
- Yoga, Exercise, Balance, Autonomic Nervous System, Functional Near-Infrared Spectroscopy, Functional Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Boettcher Webb-Waring Biomedical Research Awards
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will compare a yoga program to a non-yoga exercise program in adults with brain injuries. The investigators will measure possible improvements in balance and heartrate. The investigators also plan to measure changes in brain function and link balance and/or heartrate improvements to changes in brain function. Ideally, this work will create a foundation for a larger-scale study.
Detailed description
Background and Significance: Each year, an estimated 2.9 million Americans sustain brain injuries that result in emergency department visits, hospitalizations, and death. Although there are many treatment strategies in the early weeks and months after brain injury, millions of individuals live with residual disability. This residual, chronic disability often includes significant impairments and decreased brain function. Two prominent and interconnected impairments - poor balance and autonomic nervous system (ANS) dysfunction - can increase fall risk, decrease quality of life, and increase mortality. In adults with brain injury, ANS dysfunction is characterized by hyper-activation of the sympathetic nervous system, which can have damaging or even fatal impact on internal organs. To date, there are exceedingly few options for addressing these types of impairments or improving brain function in adults with chronic brain injury. However, community-based and holistic interventions, like hatha yoga, may be highly effective for simultaneously addressing balance and ANS impairments and may also improve brain function. Hatha yoga incorporates movements that improve balance, uses breathwork that may stabilize sympathetic and parasympathetic nervous system activity, can be adapted for individual needs, and has enhanced brain function in healthy adults. Despite this, there are few empirical studies investigating yoga for individuals with brain injury. To resolve this, the research team and investigator have conducted two yoga and brain injury feasibility studies and confirmed that recruitment, retainment, intervention, and neuroimaging procedures are feasible. In these studies, the investigators have found significant improvements in balance after yoga and preliminary evidence of improved brain function, even in the absence of measurable balance improvement. Finally, there is growing evidence that exercises, like yoga, can improve ANS function by regulating sympathetic and parasympathetic activity in healthy adults, suggesting significant potential for adults with chronic brain injury.
Project Objectives: Given feasibility study success and promising early findings. The investigators will conduct a pilot randomized control trial comparing 8-weeks of group yoga to 8-weeks of active control exercise in 48 adults with chronic brain injury. The investigators will test for improvements in balance and in ANS function using heart-rate variability (HRV) monitoring. The investigator will explore intervention-induced changes in brain function by evaluating intrinsic functional connectivity, using resting-state functional magnetic resonance imaging (rs-fMRI) and task-dependent neural activation, using a proxy of neural activity - oxygenated hemoglobin (HbO) - as measured with functional near-infrared spectroscopy (fNIRS) during concurrent balance tasks. Finally, if the investigators observe functional improvements in balance or ANS function and measurable changes in brain function, the investigator will then complete exploratory analyses to link functional improvements to changes in brain function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Hatha Yoga | Experimental | Behavioral: Adapted Hatha Yoga |
| Low-Impact Exercise | Active comparator | Behavioral: Low-Impact Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sustained acquired brain injury at least 6 months prior
- Self-reported balance impairment of moderate or greater, via the Neurobehavioral Symptom Inventory
- Standard fMRI safety screening for MRI components only (participants can complete other study components if they are ineligible or unwilling to complete MRI)
Key exclusion criteria (2 listed)
- Sustained acquired brain injury within past 6 months
- Self-reported mild balance impairment or no balance impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Hatha YogaYoga includes breath work (pranayama), gentle stretching and holding of postures (asanas), and meditation (dhyana). Modifications/adaptations are incorporated so all participants can successfully complete the yoga intervention. Yoga is delivered in a standardized progression, including: focused, slow breath with movement and breathwork throughout every session; mantras, progressively challenging yoga postures (sitting, standing, and floor); and meditation | Behavioural | Adapted Hatha Yoga |
| Low-Impact ExerciseThis includes low-intensity exercise, which is matched to the estimated metabolic costs of yoga, 2.5 Metabolic Equivalent of Task (MET). Sessions include warm up, cool down, and five, 10-minute exercise stations, (e.g., walking, balance, resistance bands, weight-bearing exercise, and core work). Control exercise will be prescribed between 2.0 to 3.0 METs, equating to 30 to 40% heart rate reserve. Heart rate zones are calculated for each participant and monitored to ensure proper intensity | Behavioural | Low-Impact Exercise |
Primary outcome
Change from Baseline in Standing Balance at 2 Months
Time frame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months..
Acquired using a force plate during simultaneous functional near-infrared spectroscopy
Change from Baseline in Autonomic Nervous System Function at 2 Months
Time frame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.
Acquired via heart rate variability assessment using electrocardiography
Change from Baseline in Functional Connectivity of Neural Networks at 2 Months
Time frame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..
Acquired via resting state functional magnetic resonance imaging
Change from Baseline in Task-Dependent Neural Activation at 2 Months
Time frame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..
Acquired pre- and post-intervention via portable functional near-infrared spectroscopy during standing balance plates with force plate.
4 secondary outcomes
Change from Baseline in Self-Reported Quality of Life at 2 Months
Time frame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..
Change from Baseline in Working Memory Performance at 2 Months
Time frame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months. .
Change from Baseline in Inhibitory Control at 2 Months
Time frame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.
Change from Baseline in Cognitive Flexibility at 2 Months
Time frame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 38077184Stephens JA, Hernandez-Sarabia JA, Sharp JL, Leach HJ, Bell C, Thomas ML, Buryznska AZ, Weaver JA, Schmid AA. Adaptive yoga versus low-impact exercise for adults with chronic acquired brain injury: a pilot randomized control trial protocol. Front Hum Neurosci. 2023 Nov 23;17:1291094. doi: 10.3389/fnhum.2023.1291094. eCollection 2023.
- Individual participant dataSharing planned: Undecided. Ideally, we will upload de-identified participant data into a public repository. We are in the process of hiring and training personnel who can fulfill this role.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclyn Stephens, PhD, OTR principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Hatha Yoga and Low-Impact Exercise in people with Acquired Brain Injury and Traumatic Brain Injury, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Standing Balance at 2 Months (time frame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months..). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.