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The purpose of this acute randomized control study is to assess the feasibility of a low-to-moderate intensity Yoga intervention (i.e. sun salutations), and examine its effect on cognitive functioning, compared to engaging in aerobic activity or seated rest. Participants will include individuals who are currently experiencing symptoms of psychosocial stress or general anxiety.
Eligible participants will be randomized to one of three groups: 1. Sun salutations (Yoga), 2. Aerobic exercise (walking on a treadmill), 3. Seated rest (watching educational videos). Each activity will be 30 minutes in duration. Immediately before and after the 30 minute intervention, participants will undergo psychosocial and cognitive assessments. Prior to the intervention, participant's physical activity will be tracked for one week, via a consumer grade accelerometer.
Baseline and post-intervention testing will include a cognitive battery, psychosocial questionnaires, flexibility testing and physiological measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sun salutations | Experimental | Sun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes. |
|
| Aerobic exercise | Active Comparator | Walking on a treadmill at low to moderate intensity for 30 minutes. |
|
| Seated rest (attentional control) | Other | Watching educational videos for 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sun salutations | Behavioral | This group will be asked to participate in 25 minutes of low-to-moderate intensity Yoga. This acute session will include engaging in sun salutations, breathing exercises and relaxation. Sun salutations involves performing 10 postures in a particular sequence, and then repeating that sequence. Some of the positions include bending over and touching one's toes, and lying belly-down on the ground and pushing up from ground while arching backwards. The activity will begin as a low intensity activity for the first 5 minutes, and the intensity will be gradually increased. Participants' heart rate will be measured before and after the intervention. The intervention will be delivered by a video displayed on a tablet device. An orientation session in the beginning will familiarize participants with the activity. |
| Measure | Description | Time Frame |
|---|---|---|
| N-back Task (Working Memory) | This is a computerized task measuring the working memory domain of cognition. The task had 3 conditions, namely, 0-back, 1-back and 2-back. Participants are presented with a series of stimuli one after the other. They have to decide whether the stimulus currently presented is the same as the stimulus presented "n" items before. For the 1-back task, participants have to decide whether the stimulus matches the stimulus presented 1 earlier. For the 2- back task, they have to decide whether the stimulus matches the stimulus presented 2 earlier. Reaction time and accuracy of the response are recorded. | Change from baseline performance on the n-back at 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Trail Making Test A and B (Global Cognition) | This is a paper pencil task having 2 parts- Trails A and Trails B, with Trails B being more complex. In Trails A, there are 25 circles on a piece of paper numbered 1-25. Participants have to join these numbers in ascending order, as quickly as they can, without lifting their pencil. In Trails B, the participants have to join 25 circles in an ascending order, but they have to alternate between numbers and letters (1-A-2-B-3-C). Time to complete the task correctly is recorded. |
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Inclusion Criteria:
Anyone between the ages of 18-45 years
Anyone with a score of 3 or higher on the Generalized Anxiety Disorder symptom checklist of the Diagnostic and Statistical Manual 5. That is, anyone meeting 3 or more symptoms, on more days of the week than not, for the past 6 months:
1. Restlessness, feeling keyed up or on edge. 2. Being easily fatigued. 3. Difficulty concentrating or mind going blank. 4. Irritability. 5. Muscle tension. 6. Sleep disturbance (difficulty falling or staying asleep, or restless, unsatisfying sleep).
Ability to exercise at moderate to vigorous activity levels (defined as 50%-75% of the adjusted age-predicted maximum heart rate)
Access to a smartphone and willingness to allow research staff to install a mobile activity tracker application (and space to allow for installation)
Willingness to be randomized into one of three groups
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean P Mullen, PhD | University of Illinois at Urbana-Champaign | Principal Investigator |
| Madhura Phansikar, MA | University of Illinois at Urbana-Champaign | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Urbana-Champaign | Urbana | Illinois | 61801 | United States |
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| Label | URL |
|---|---|
| Exercise, Technology, and Cognition Laboratory | View source |
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De-identified individual participant data for all primary and secondary outcome measures will be made available.
Although this is not an NIH-funded study, we will update these records within 1 year of data collection completion per NIH guidelines.
Data will be accessible on an open site (e.g., Open Science Framework https://osf.io/) with a request to interested parties to engage with the investigative team about any publication of these data in an effort to avoid redundancy. Appropriate authorship crediting investigators involved in the parent study conceptualization, and any consultation regarding data interpretation should be sought by any researchers interested in publishing these data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sun Salutations | Sun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes. Sun salutations: This group will be asked to participate in 25 minutes of low-to-moderate intensity Yoga. This acute session will include engaging in sun salutations, breathing exercises and relaxation. Sun salutations involves performing 10 postures in a particular sequence, and then repeating that sequence. Some of the positions include bending over and touching one's toes, and lying belly-down on the ground and pushing up from ground while arching backwards. The activity will begin as a low intensity activity for the first 5 minutes, and the intensity will be gradually increased. Participants' heart rate will be measured before and after the intervention. The intervention will be delivered by a video displayed on a tablet device. An orientation session in the beginning will familiarize participants with the activity. |
| FG001 | Aerobic Exercise | Walking on a treadmill at low to moderate intensity for 30 minutes. Aerobic exercise: This group will be asked to walk on the treadmill for the same amount of time (i.e. 25 minutes) at a moderate intensity (50-70% of their maximum heart rate). Participants will receive an initial 5-minute orientation and then begin at a self-selected speed for the first 5 minutes. Heart rate will be measured and monitored by an undergraduate research assistant. Speed will be increased after 5 minutes if participants have not reached the moderate zone. If participants still have not reached the target heart rate zone by the 10-min mark, the incline of the treadmill will be increased by a 5% grade until the zone is reached. |
| FG002 | Seated Rest (Attentional Control) | Watching educational videos for 30 minutes. Seated rest: This group will be watching educational videos for the same amount of time as the intervention groups. An orientation session of 5 minutes will be held in the beginning. Participants will be watching videos on general health related topics, such as healthy eating, while being seated in a quiet room, free of distractions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sun Salutations | Sun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes. Sun salutations: This group will be asked to participate in 25 minutes of low-to-moderate intensity Yoga. This acute session will include engaging in sun salutations, breathing exercises and relaxation. Sun salutations involves performing 10 postures in a particular sequence, and then repeating that sequence. Some of the positions include bending over and touching one's toes, and lying belly-down on the ground and pushing up from ground while arching backwards. The activity will begin as a low intensity activity for the first 5 minutes, and the intensity will be gradually increased. Participants' heart rate will be measured before and after the intervention. The intervention will be delivered by a video displayed on a tablet device. An orientation session in the beginning will familiarize participants with the activity. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | N-back Task (Working Memory) | This is a computerized task measuring the working memory domain of cognition. The task had 3 conditions, namely, 0-back, 1-back and 2-back. Participants are presented with a series of stimuli one after the other. They have to decide whether the stimulus currently presented is the same as the stimulus presented "n" items before. For the 1-back task, participants have to decide whether the stimulus matches the stimulus presented 1 earlier. For the 2- back task, they have to decide whether the stimulus matches the stimulus presented 2 earlier. Reaction time and accuracy of the response are recorded. | Posted | Mean | Standard Deviation | Milliseconds | Change from baseline performance on the n-back at 30 minutes |
|
2 hours
No adverse events occured
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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 | Sun Salutations | Sun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes. Sun salutations: This group will be asked to participate in 25 minutes of low-to-moderate intensity Yoga. This acute session will include engaging in sun salutations, breathing exercises and relaxation. Sun salutations involves performing 10 postures in a particular sequence, and then repeating that sequence. Some of the positions include bending over and touching one's toes, and lying belly-down on the ground and pushing up from ground while arching backwards. The activity will begin as a low intensity activity for the first 5 minutes, and the intensity will be gradually increased. Participants' heart rate will be measured before and after the intervention. The intervention will be delivered by a video displayed on a tablet device. An orientation session in the beginning will familiarize participants with the activity. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sean P Mullen | University of Illinois Urbana Champaign | 217-244-4502 | spmullen@illinois.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2019 | Aug 24, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2021 | Aug 24, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2019 | Aug 24, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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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|
| Aerobic exercise | Behavioral | This group will be asked to walk on the treadmill for the same amount of time (i.e. 25 minutes) at a moderate intensity (50-70% of their maximum heart rate). Participants will receive an initial 5-minute orientation and then begin at a self-selected speed for the first 5 minutes. Heart rate will be measured and monitored by an undergraduate research assistant. Speed will be increased after 5 minutes if participants have not reached the moderate zone. If participants still have not reached the target heart rate zone by the 10-min mark, the incline of the treadmill will be increased by a 5% grade until the zone is reached. |
|
| Seated rest | Behavioral | This group will be watching educational videos for the same amount of time as the intervention groups. An orientation session of 5 minutes will be held in the beginning. Participants will be watching videos on general health related topics, such as healthy eating, while being seated in a quiet room, free of distractions. |
|
| Change from baseline performance at 30 minutes |
| Digit Symbol Substitution Test (Processing Speed) | In this task, participants are presented with a code key, in which numbers 1-9 are matched with a unique symbol. Then, they are presented with a sheet of paper having a series of symbols on it. Using the codekey, participants have to read aloud, the numbers that the symbols are associated with, in 2 minutes. The accuracy is recorded. | Change from baseline performance at 30 minutes |
| State Trait Anxiety Questionnaire | This questionnaire has 20 items for assessing state anxiety. Participants respond on a 4-point scale ("Not at all" to "Very much so"). Composite is calculated by summing the items. Range: 20 (min) - 80 (max). Higher scores indicate greater anxiety. | Change from baseline performance at 30 minutes |
| Visual Analog Scale for Stress | Participants have to indicate how stressed they are currently feeling on a scale ranging from 0 (none) to 100 (as bad as it gets). Higher scores mean more stress. | Change from baseline performance at 30 minutes |
| Perceived Mental Fatigue | Participants self rate their present moment feelings on a scale from 1 - 5 (1=not true at all, 5=very true) yielding a mean score across all 7 items, with higher scores indicating greater mental fatigue. Range for composite score: 1 (min) - 5 (max). | Change from baseline performance at 30 minutes |
| Focus of Attention | Participants are asked to self rate (1 item) their focus of attention while engaged in the previous activity. Responses range from 0 (Internal thoughts) to 10 (external thoughts), with higher scores representing external focus of attention. Range: 0 (min)- 10 (max). | Day 1 |
| Feeling Scale | This scale measures how a participant is feeling at the present moment (valence) after a bout of exercise. It is an 11-point one-item measure ranging from +5 (very good) to -5 (very bad). Higher scores represent positive affect. Range: -55 (min) to 55 (max). | Change from baseline performance at 30 minutes |
| Heart Rate | Participants' heart rate will be measured using an oxymeter. | Change from baseline performance at 30 minutes |
| Rating of Perceived Exertion | Participants are asked to self rate their feeling of exertion on a 1-item question (11 point scale), ranging from 6 (no exertion) to 20 (maximal exertion), for the activity they were engaged in during the intervention. Range: 6 (min) to 20 (max). | Day 1 |
| Rating of Enjoyment and Intervention | Participants will rate their enjoyment in terms of the delivery method and the intervention. This will include questions such as 'Did you like the video instruction for sun salutations?', 'Would you recommend this activity to your family and friends?' Participants had a dichotomous response choice of "yes" or "no". A composite score was calculated as an average across X items. Range of the composite score: 0 to 1. A higher score indicates higher enjoyment. | Day 1 |
| Rating of Technology Ease of Use and Usability | Participants from the yoga group only will rate the technology used to deliver the intervention, in terms of its ease of use and usability. The items are based on the Technology Acceptance Model and will include questions such as 'The Yoga video was clear and understandable.' Response ranges from 1 to 6, and a composite score is reported as an average of the responses. Range of the composite score: 1 (min) - 6 (max). Higher scores represent better technology usability. | Day 1 |
| BG001 | Aerobic Exercise | Walking on a treadmill at low to moderate intensity for 30 minutes. Aerobic exercise: This group will be asked to walk on the treadmill for the same amount of time (i.e. 25 minutes) at a moderate intensity (50-70% of their maximum heart rate). Participants will receive an initial 5-minute orientation and then begin at a self-selected speed for the first 5 minutes. Heart rate will be measured and monitored by an undergraduate research assistant. Speed will be increased after 5 minutes if participants have not reached the moderate zone. If participants still have not reached the target heart rate zone by the 10-min mark, the incline of the treadmill will be increased by a 5% grade until the zone is reached. |
| BG002 | Seated Rest (Attentional Control) | Watching educational videos for 30 minutes. Seated rest: This group will be watching educational videos for the same amount of time as the intervention groups. An orientation session of 5 minutes will be held in the beginning. Participants will be watching videos on general health related topics, such as healthy eating, while being seated in a quiet room, free of distractions. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| N-back Task (Working Memory) | This is a computerized task measuring the working memory domain of cognition. The task had 3 conditions, namely, 0-back, 1-back and 2-back. Participants are presented with a series of stimuli one after the other. They have to decide whether the stimulus currently presented is the same as the stimulus presented "n" items before. For the 2- back task, they have to decide whether the stimulus matches the stimulus presented 2 earlier. The data presented here is 2-back non-match reaction time, which is the most difficult condition. | Mean | Standard Deviation | milliseconds |
|
| OG001 | Aerobic Exercise | Walking on a treadmill at low to moderate intensity for 30 minutes. Aerobic exercise: This group will be asked to walk on the treadmill for the same amount of time (i.e. 25 minutes) at a moderate intensity (50-70% of their maximum heart rate). Participants will receive an initial 5-minute orientation and then begin at a self-selected speed for the first 5 minutes. Heart rate will be measured and monitored by an undergraduate research assistant. Speed will be increased after 5 minutes if participants have not reached the moderate zone. If participants still have not reached the target heart rate zone by the 10-min mark, the incline of the treadmill will be increased by a 5% grade until the zone is reached. |
| OG002 | Seated Rest (Attentional Control) | Watching educational videos for 30 minutes. Seated rest: This group will be watching educational videos for the same amount of time as the intervention groups. An orientation session of 5 minutes will be held in the beginning. Participants will be watching videos on general health related topics, such as healthy eating, while being seated in a quiet room, free of distractions. |
|
|
| Secondary | Trail Making Test A and B (Global Cognition) | This is a paper pencil task having 2 parts- Trails A and Trails B, with Trails B being more complex. In Trails A, there are 25 circles on a piece of paper numbered 1-25. Participants have to join these numbers in ascending order, as quickly as they can, without lifting their pencil. In Trails B, the participants have to join 25 circles in an ascending order, but they have to alternate between numbers and letters (1-A-2-B-3-C). Time to complete the task correctly is recorded. | Posted | Mean | Standard Deviation | seconds | Change from baseline performance at 30 minutes |
|
|
|
| Secondary | Digit Symbol Substitution Test (Processing Speed) | In this task, participants are presented with a code key, in which numbers 1-9 are matched with a unique symbol. Then, they are presented with a sheet of paper having a series of symbols on it. Using the codekey, participants have to read aloud, the numbers that the symbols are associated with, in 2 minutes. The accuracy is recorded. | Posted | Mean | Standard Deviation | Correct responses | Change from baseline performance at 30 minutes |
|
|
|
| Secondary | State Trait Anxiety Questionnaire | This questionnaire has 20 items for assessing state anxiety. Participants respond on a 4-point scale ("Not at all" to "Very much so"). Composite is calculated by summing the items. Range: 20 (min) - 80 (max). Higher scores indicate greater anxiety. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline performance at 30 minutes |
|
|
|
| Secondary | Visual Analog Scale for Stress | Participants have to indicate how stressed they are currently feeling on a scale ranging from 0 (none) to 100 (as bad as it gets). Higher scores mean more stress. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline performance at 30 minutes |
|
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|
| Secondary | Perceived Mental Fatigue | Participants self rate their present moment feelings on a scale from 1 - 5 (1=not true at all, 5=very true) yielding a mean score across all 7 items, with higher scores indicating greater mental fatigue. Range for composite score: 1 (min) - 5 (max). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline performance at 30 minutes |
|
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| Secondary | Focus of Attention | Participants are asked to self rate (1 item) their focus of attention while engaged in the previous activity. Responses range from 0 (Internal thoughts) to 10 (external thoughts), with higher scores representing external focus of attention. Range: 0 (min)- 10 (max). | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
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| Secondary | Feeling Scale | This scale measures how a participant is feeling at the present moment (valence) after a bout of exercise. It is an 11-point one-item measure ranging from +5 (very good) to -5 (very bad). Higher scores represent positive affect. Range: -55 (min) to 55 (max). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline performance at 30 minutes |
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| Secondary | Heart Rate | Participants' heart rate will be measured using an oxymeter. | Posted | Mean | Standard Deviation | beats per minute | Change from baseline performance at 30 minutes |
|
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| Secondary | Rating of Perceived Exertion | Participants are asked to self rate their feeling of exertion on a 1-item question (11 point scale), ranging from 6 (no exertion) to 20 (maximal exertion), for the activity they were engaged in during the intervention. Range: 6 (min) to 20 (max). | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
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| Secondary | Rating of Enjoyment and Intervention | Participants will rate their enjoyment in terms of the delivery method and the intervention. This will include questions such as 'Did you like the video instruction for sun salutations?', 'Would you recommend this activity to your family and friends?' Participants had a dichotomous response choice of "yes" or "no". A composite score was calculated as an average across X items. Range of the composite score: 0 to 1. A higher score indicates higher enjoyment. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
|
|
| Secondary | Rating of Technology Ease of Use and Usability | Participants from the yoga group only will rate the technology used to deliver the intervention, in terms of its ease of use and usability. The items are based on the Technology Acceptance Model and will include questions such as 'The Yoga video was clear and understandable.' Response ranges from 1 to 6, and a composite score is reported as an average of the responses. Range of the composite score: 1 (min) - 6 (max). Higher scores represent better technology usability. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Aerobic Exercise | Walking on a treadmill at low to moderate intensity for 30 minutes. Aerobic exercise: This group will be asked to walk on the treadmill for the same amount of time (i.e. 25 minutes) at a moderate intensity (50-70% of their maximum heart rate). Participants will receive an initial 5-minute orientation and then begin at a self-selected speed for the first 5 minutes. Heart rate will be measured and monitored by an undergraduate research assistant. Speed will be increased after 5 minutes if participants have not reached the moderate zone. If participants still have not reached the target heart rate zone by the 10-min mark, the incline of the treadmill will be increased by a 5% grade until the zone is reached. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Seated Rest (Attentional Control) | Watching educational videos for 30 minutes. Seated rest: This group will be watching educational videos for the same amount of time as the intervention groups. An orientation session of 5 minutes will be held in the beginning. Participants will be watching videos on general health related topics, such as healthy eating, while being seated in a quiet room, free of distractions. | 0 | 24 | 0 | 24 | 0 | 24 |
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