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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT009073-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| United States Naval Medical Center, San Diego | FED |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Our primary aim is to assess the feasibility of conducting yoga research among active-duty military personnel with Chronic Low Back Pain (CLBP) and/or Chronic Neck Pain (CNP). In addition, we will evaluate the yoga intervention preferences and refine an existing yoga intervention to address those needs. The study will prepare us for a R01 funded pragmatic clinical trial of yoga for CLBP and CNP in active-duty military.
In preparation for a full-scale study via a subsequent R01 proposal, our study objective is to examine the feasibility and acceptability of conducting a yoga RCT among active-duty military personnel with CLBP/CNP in military and community settings. The study will be conducted in two phases: Phase 1 (completed) involved obtaining IRB approval to conduct research in military settings, collecting qualitative data from stakeholders on attitudes and preferences for yoga interventions, and refining the existing Yoga for CLBP intervention for the needs of active-duty military and persons with CNP. Phase 2 will recruit and randomize 50 military personnel with CLBP or CNP to either active hatha or restorative yoga. Pain interference, pain severity, physical function, opioid medication use, and mental health outcomes are of primary interest. Mechanisms will also be studied.
The specific aims are as follows:
Aim 1: Evaluate and navigate barriers and facilitators for obtaining IRB approval to conduct randomized controlled intervention studies with active-duty military personnel.
Aim 2: Evaluate the acceptability of and preferences for yoga interventions among active-duty military personnel with CLBP/CNP.
Aim 3: Refine and modify the existing Yoga for CLBP intervention to address CNP, and the needs of active-duty military personnel.
Aim 4: Evaluate the feasibility of recruitment of active-duty military personnel with CLBP/CNP into a yoga RCT.
Aim 5: Evaluate the adherence of this population to the two yoga interventions. Aim 6: Obtain effect size estimates to inform power analyses for a full-scale RCT.
Accomplishing these aims will prepare us for an R01 proposal to study the efficacy of yoga for military personnel with CLBP/CNP in a full-scale randomized, controlled trial. To be successful and maximize the scientific knowledge obtained from an R01 study, it is crucial to first establish working relationships with military researchers, ensure that recruitment and randomized assignment are feasible, pilot test measurement strategies, and ensure that both interventions will be well-attended and have been optimally chosen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hatha Yoga | Experimental | This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. |
|
| Restorative Yoga | Active Comparator | This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga: Active Hatha | Other | Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | Brief Pain Inventory (BPI) : Self-Report measure of pain interference and pain severity consisting of 14 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain interference score is the mean of the 7 interference items. The pain severity score is the mean of 4 severity items. Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating more pain interference. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
| Measure | Description | Time Frame |
|---|---|---|
| Roland-Morris Disability Questionnaire | Self-report measure consisting of 23 questions that ask about limitations experienced for a variety of daily activities. Scale scores are the sum of items endorsed, thus scores range from 0-23 with higher scores indicating more back pain-related disability. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life (HRQOL) Short-form 12 (SF12) - Physical | 12-Item self-report measure on individual's views about their physical health. Scores are scaled to range from 0-100 with higher scores indicating better physical quality of life. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Groessl, Ph.D. | University of California, San Diego | Principal Investigator |
| Ian Fowler, MD | Navy Medical Center San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD's Health Services Research Center | San Diego | California | 92121 | United States | ||
| Navy Medical Center San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35734420 | Derived | Groessl EJ, Casteel D, McKinnon S, McCarthy A, Schmalzl L, Chang DG, Fowler IM, Park CL. Comparing Types of Yoga for Chronic Low Back and Neck Pain in Military Personnel: A Feasibility Randomized Controlled Trial. Glob Adv Health Med. 2022 Jun 16;11:2164957X221094596. doi: 10.1177/2164957X221094596. eCollection 2022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hatha Yoga | This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations |
| FG001 | Restorative Yoga | This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| End of Intervention - 12 Weeks |
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| ||||||||||||||||||
| Final Assessment - 6 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hatha Yoga | This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Interference | Brief Pain Inventory (BPI) : Self-Report measure of pain interference and pain severity consisting of 14 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain interference score is the mean of the 7 interference items. The pain severity score is the mean of 4 severity items. Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating more pain interference. | Effect size | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hatha Yoga | This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| leg surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | One participant had an surgey on their leg and could not attend yoga. Event was unrelated to the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erik Groessl, PhD | UC San Diego | 858-642-6347 | egroessl@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2019 | Jan 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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We will be conducting a pilot RCT with two types of yoga interventions. A total of 50 participants will be randomized to attend either active Hatha yoga or restorative yoga. Enrollment will be conducted on a rolling basis.
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| Yoga: Restorative | Other | Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement. |
|
|
| BPI Pain Severity | Brief Pain Inventory (BPI) : Self-Report measure of pain severity consisting of 4 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain severity score is the mean of 4 severity items. Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating greater pain severity. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
| Neck Disability Index | Ten-item self-report measure to assess neck pain interference in daily life activities. Each of the 10 items is scored from 0 - 5. The items are summed and scores range from 0-50 with higher scores indicating greater disability due to neck pain. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
| HRQOL - SF12 - Mental Health |
Mental Component Score for the SF12 Scores are scaled to range from 0-100 with higher scores indicating better mental quality of life. |
| assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
| The Fatigue Severity Scale (FSS) | The Fatigue Severity Scale (FSS) assesses the impact and severity of fatigue with 9 items. A score of > 4.0 constitutes severe fatigue.The measure has good psychometrics for pain disorders. This is a 9-item questionnaire with questions related to how fatigue interferes with certain activities and severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score indicate greater fatigue severity. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
| CES-D 10 | Ten-item self-report measure on the frequency of mood symptoms. Scores greater than or equal to 10 indicate depression. The 10 items are rated on a Likert scale from 0-3. Thus the total score ranges from 0-30 with higher scores indicating more depression. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
| AUDIT-C | The AUDIT-C is a 3-item alcohol screen that reliably identifies patients who are hazardous drinkers or have alcohol use disorders. The AUDIT-C is a modified version of the 10 question AUDIT instrument. | baseline, 12-weeks, 6-months |
| Dimensions of Anger Reactions (DAR) | Developed by Forbes et al., The Dimensions of Anger Reactions questionnaire consists of 7 items and has demonstrated strong internal reliability and concurrent validity with other existing measures of anger. | baseline, 12-weeks, 6-months |
| The Brief Resilience Scale (BRS) | The Brief Resilience Scale (BRS) assesses and individuals ability to recover from stress or trauma. The measure consists of six items and has good reliability and validity. The score is the mean of the 6 items, which are rated from 1 to 5. Scores range from 1-5.0 and higher scores indicate greater resilience. | baseline, 12-weeks, 6-months |
| Self Efficacy for Chronic Low Back Pain Scale | A 6-item self-report measure of an individual's confidence in performing certain activities. Items range from 1 (not at all confident) to 10 (totally confident). The score is the mean of the items and ranges from 1-10 with higher scores indicating greater self-efficacy. | baseline, 12-weeks, 6-months |
| Physical Measures: Grip Strength | Grip strength will be measured with a hydraulic dynamometer. Two trials will be performed for each hand and the best performance will be taken for each side. The average of both hands is used for analysis. | baseline, 12-weeks, 6-months |
| Physical Measures: Core Stabilization | Prone and supine bridge positions will assess core stabilization. Participants begin on their elbows in the prone position with shoulders, hips, and ankles aligned. The supine position is tested next, with knees flexed 90 degrees and pelvis raised from the floor with shoulders, hips, and knees aligned. Assessors record length of time (120 seconds max) that each position is held in proper form. | baseline, 12-weeks, 6-months |
| Physical Measures: Balance | Balance will be measures performance on a one-leg stand on each side. Assessors record length of time (2 minutes max) that each one-leg stand is held in proper form. | baseline, 12-weeks, 6-months |
| PROMIS - Pain Intensity | PROMIS (Patient-Reported Outcomes Measurement Information System) measure - Pain Intensity The PROMIS Pain Intensity instrument consists of three items with 5 response options ranging from 1 ("had no pain") to 5 ("very severe") addressing how much pain the person experiences now and in the past 7 days. The raw score is the sum of the three questions, with a minimum of 3 and a maximum score of 15, with higher scores indicating greater pain intensity. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
| San Diego |
| California |
| 92134 |
| United States |
| NOT COMPLETED |
|
|
| BG001 | Restorative Yoga | This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Restorative Yoga | This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement. |
|
|
| Secondary | Roland-Morris Disability Questionnaire | Self-report measure consisting of 23 questions that ask about limitations experienced for a variety of daily activities. Scale scores are the sum of items endorsed, thus scores range from 0-23 with higher scores indicating more back pain-related disability. | effect sizes | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
|
|
|
| Secondary | BPI Pain Severity | Brief Pain Inventory (BPI) : Self-Report measure of pain severity consisting of 4 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain severity score is the mean of 4 severity items. Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating greater pain severity. | effect sizes - Cohen's d | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
|
|
|
| Secondary | Neck Disability Index | Ten-item self-report measure to assess neck pain interference in daily life activities. Each of the 10 items is scored from 0 - 5. The items are summed and scores range from 0-50 with higher scores indicating greater disability due to neck pain. | effect sizes | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
|
|
|
| Other Pre-specified | Health Related Quality of Life (HRQOL) Short-form 12 (SF12) - Physical | 12-Item self-report measure on individual's views about their physical health. Scores are scaled to range from 0-100 with higher scores indicating better physical quality of life. | effect sizes | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
|
|
|
| Other Pre-specified | HRQOL - SF12 - Mental Health | Mental Component Score for the SF12 Scores are scaled to range from 0-100 with higher scores indicating better mental quality of life. | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
|
|
|
| Other Pre-specified | The Fatigue Severity Scale (FSS) | The Fatigue Severity Scale (FSS) assesses the impact and severity of fatigue with 9 items. A score of > 4.0 constitutes severe fatigue.The measure has good psychometrics for pain disorders. This is a 9-item questionnaire with questions related to how fatigue interferes with certain activities and severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score indicate greater fatigue severity. | effect sizes | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
|
|
|
| Other Pre-specified | CES-D 10 | Ten-item self-report measure on the frequency of mood symptoms. Scores greater than or equal to 10 indicate depression. The 10 items are rated on a Likert scale from 0-3. Thus the total score ranges from 0-30 with higher scores indicating more depression. | Not Posted | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported | Participants |
| Other Pre-specified | AUDIT-C | The AUDIT-C is a 3-item alcohol screen that reliably identifies patients who are hazardous drinkers or have alcohol use disorders. The AUDIT-C is a modified version of the 10 question AUDIT instrument. | Not Posted | baseline, 12-weeks, 6-months | Participants |
| Other Pre-specified | Dimensions of Anger Reactions (DAR) | Developed by Forbes et al., The Dimensions of Anger Reactions questionnaire consists of 7 items and has demonstrated strong internal reliability and concurrent validity with other existing measures of anger. | Not Posted | baseline, 12-weeks, 6-months | Participants |
| Other Pre-specified | The Brief Resilience Scale (BRS) | The Brief Resilience Scale (BRS) assesses and individuals ability to recover from stress or trauma. The measure consists of six items and has good reliability and validity. The score is the mean of the 6 items, which are rated from 1 to 5. Scores range from 1-5.0 and higher scores indicate greater resilience. | Not Posted | baseline, 12-weeks, 6-months | Participants |
| Other Pre-specified | Self Efficacy for Chronic Low Back Pain Scale | A 6-item self-report measure of an individual's confidence in performing certain activities. Items range from 1 (not at all confident) to 10 (totally confident). The score is the mean of the items and ranges from 1-10 with higher scores indicating greater self-efficacy. | Not Posted | baseline, 12-weeks, 6-months | Participants |
| Other Pre-specified | Physical Measures: Grip Strength | Grip strength will be measured with a hydraulic dynamometer. Two trials will be performed for each hand and the best performance will be taken for each side. The average of both hands is used for analysis. | Not Posted | baseline, 12-weeks, 6-months | Participants |
| Other Pre-specified | Physical Measures: Core Stabilization | Prone and supine bridge positions will assess core stabilization. Participants begin on their elbows in the prone position with shoulders, hips, and ankles aligned. The supine position is tested next, with knees flexed 90 degrees and pelvis raised from the floor with shoulders, hips, and knees aligned. Assessors record length of time (120 seconds max) that each position is held in proper form. | Not Posted | baseline, 12-weeks, 6-months | Participants |
| Other Pre-specified | Physical Measures: Balance | Balance will be measures performance on a one-leg stand on each side. Assessors record length of time (2 minutes max) that each one-leg stand is held in proper form. | Not Posted | baseline, 12-weeks, 6-months | Participants |
| Other Pre-specified | PROMIS - Pain Intensity | PROMIS (Patient-Reported Outcomes Measurement Information System) measure - Pain Intensity The PROMIS Pain Intensity instrument consists of three items with 5 response options ranging from 1 ("had no pain") to 5 ("very severe") addressing how much pain the person experiences now and in the past 7 days. The raw score is the sum of the three questions, with a minimum of 3 and a maximum score of 15, with higher scores indicating greater pain intensity. | effect sizes | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported |
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Restorative Yoga | This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement. | 0 | 25 | 0 | 25 | 4 | 25 |
|
| Broken foot or ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to yoga intervention. |
|
| Back surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Surgery unrelated to intervention |
|
| Unspecified surgery | Surgical and medical procedures | Systematic Assessment |
|
| Shoulder injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Injured their shoulder during military training activity. Unrelated to yoga. |
|
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