| Primary | Change From Baseline in Five Times Sit-to-stand Time | From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility. | Data for STS time missing for some participants at 10-week timepoint. | Posted | | Mean | Standard Deviation | seconds | | Baseline before surgery, 10 weeks after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.76± 3.78
- OG001-1.33± 3.29
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | 0.436 | | | | | | | | | | | | | | Superiority | | |
|
| Primary | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population. | Missing data for some participants at 10week timepoint | Posted | | Mean | Standard Deviation | change in percentile of the t-score | | Baseline before surgery, 10 weeks after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
|
| Primary | Change From Baseline in Quiet Unstable Sitting Test | Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | Scaled Z-score | | Baseline before surgery, 10 weeks after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
|
| Secondary | Change in Hernia Related Quality of Life Survey From Baseline | The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | points | | baseline before surgery, 10 weeks after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Change in Timed Up-And-Go Time From Baseline | Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | seconds | | baseline before surgery, 10 weeks after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Change From Baseline in International Physical Activity Questionnaire - Short Form | Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both. | Trial began with iPAQ-long form but then we switched to iPAQ-short form to reduce participant burden. Hence the smaller number of participants analyzed. In addition, some participants chose not to complete the survey. | Posted | | Mean | Standard Deviation | MET-minutes per week | | baseline before surgery, 10 weeks after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Change From Baseline in Tampa Scale of Kinesiophobia - Short Form | Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | points | | baseline before surgery, 10 weeks after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory | Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge. A recurrence is determined by if the patient reports thinking the hernia has come back, feeling or seeing a bulge, or having pain or symptoms at the site. A positive response to any of these 3 questions is considered a recurrence. A recurrence is considered a suboptimal outcome. | | Posted | | Count of Participants | | Participants | | 1 year after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Change in Hernia Related Quality of Life Survey From Baseline | The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | points | | baseline before surgery, 1 year after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Change in Timed Up-And-Go Time From Baseline | Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | seconds | | baseline before surgery, 1 year after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Change From Baseline in International Physical Activity Questionnaire - Long Form | Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both. | Switched to iPAQ-short form part way through the trial, when only 3 participants had completed the last timepoint. | Posted | | Mean | Standard Deviation | MET-minutes per week | | baseline before surgery, 1 year after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Change From Baseline in Tampa Scale of Kinesiophobia - Short Form | Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | points | | baseline before surgery, 1 year after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Change From Baseline in Five Times Sit-to-stand Time | From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | seconds | | baseline before surgery, 1 year after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Secondary | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | change in percentile of the t-score | | baseline before surgery, 1 year after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
|
| Secondary | Change From Baseline in Quiet Unstable Sitting Test | Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | Scaled Z-score | | baseline before surgery, 1 year after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
|
| Other Pre-specified | Change in Hernia Related Quality of Life Survey From Baseline | The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | points | | baseline before surgery, 30 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change in Timed Up-And-Go Time From Baseline | Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | seconds | | baseline before surgery, 30 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change From Baseline in International Physical Activity Questionnaire - Short Form | Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | MET-minutes per week | | baseline before surgery, 30 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change From Baseline in Tampa Scale of Kinesiophobia - Short Form | Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | points | | baseline before surgery, 30 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change From Baseline in Five Times Sit-to-stand Time | From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | seconds | | baseline before surgery, 30 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | change in percentile of the t-score | | baseline before surgery, 30 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
|
| Other Pre-specified | Change From Baseline in Quiet Unstable Sitting Test | Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint, and/or they were uncomfortable performing the test. | Posted | | Mean | Standard Deviation | Scaled Z-score | | baseline before surgery, 30 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
|
| Other Pre-specified | Change in Hernia Related Quality of Life Survey From Baseline | The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | points | | baseline before surgery, 6 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change in Timed Up-And-Go Time From Baseline | Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | seconds | | baseline before surgery, 6 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change From Baseline in International Physical Activity Questionnaire - Long Form | Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both. | Stopped measuring this outcome in favor of iPAQ-short form after a few participants got through the study. | Posted | | Mean | Standard Deviation | MET-minutes per week | | baseline before surgery, 6 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change From Baseline in Tampa Scale of Kinesiophobia - Short Form | The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | points | | baseline before surgery, 6 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change From Baseline in Five Times Sit-to-stand Time | From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | seconds | | baseline before surgery, 6 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
| |
| Other Pre-specified | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population. | Some participants did not complete this survey at baseline or at this post-operative timepoint. | Posted | | Mean | Standard Deviation | change in percentile of the t-score | | baseline before surgery, 6 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
|
| Other Pre-specified | Change From Baseline in Quiet Unstable Sitting Test | Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound. | The number of participants for this outcome measure is less than the overall population because some participants were unable to come for in-person testing at this timepoint. | Posted | | Mean | Standard Deviation | Scaled Z-score | | baseline before surgery, 6 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Standard Post-operative Instructions | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. | | OG001 | Supervised Physical Therapy | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
|