Abdominal Wall, Hernia, Herniorrhaphy, Physical Therapy Modalities, Postoperative Period, Ventral Hernia
Conditions
Keywords
ventral hernia repair, abdominal core health, physical therapy
Brief summary
This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will perform assessments of several activities of daily living and complete several surveys detailing their pre-surgical abilities, quality of life, and pain. Immediately after their surgical procedure, patients will be randomized in a single-blind manner (investigator) in a 1:1 ratio to supervised physical therapy (8 weeks, twice weekly) or standard post-surgical precautions. Assessments and surveys will be repeated by the blinded investigator at 30 days, 10 weeks, 6 months, and 1 year after surgery.
Interventions
The twice-per-week 8-week course of supervised physical therapy begins 2 weeks after surgery. It targets abdominal core function through progressive muscle retraining and strengthening, and patient-specific posture and body mechanics education.
OTHERPost-operative Precautions
This intervention includes standard of care post-operative instructions typically given to patients undergoing ventral hernia repair across the world. These include limiting strenuous physical activity and a lifting restriction of no more than 10 pounds for 6 weeks. Binder use is also encouraged for 4-6 weeks after the operation.
Sponsors
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 18+ * Diagnosis of ventral hernia * Scheduled for elective ventral hernia repair * Independent functional status * Transverse hernia width of 2cm or greater
Exclusion criteria
* Previously diagnosed movement or balance disorder * Use of ambulatory assistive device (walker or cane) * Not currently undergoing or planning to undergo physical therapy or other skilled exercise intervention supervised by a medical rehabilitation professional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Five Times Sit-to-stand Time | Baseline before surgery, 10 weeks after surgery | 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. |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | Baseline before surgery, 10 weeks after surgery | 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. |
| Change From Baseline in Quiet Unstable Sitting Test | Baseline before surgery, 10 weeks after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hernia Related Quality of Life Survey From Baseline | baseline before surgery, 10 weeks after surgery | 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. |
| Change in Timed Up-And-Go Time From Baseline | baseline before surgery, 10 weeks after surgery | 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. |
| Change From Baseline in International Physical Activity Questionnaire - Short Form | baseline before surgery, 10 weeks after surgery | 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. |
| Change From Baseline in Tampa Scale of Kinesiophobia - Short Form | baseline before surgery, 10 weeks after surgery | 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. |
| Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory | 1 year after surgery | 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. |
| Change From Baseline in International Physical Activity Questionnaire - Long Form | baseline before surgery, 1 year after surgery | 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. |
| Change From Baseline in Five Times Sit-to-stand Time | baseline before surgery, 1 year after surgery | 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. |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | baseline before surgery, 1 year after surgery | 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. |
| Change From Baseline in Quiet Unstable Sitting Test | baseline before surgery, 1 year after surgery | 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. |
Countries
United States
Participant flow
Recruitment details
We will recruit up to 140 participants. We aim to enroll 6 participants/month, enabling full trial accrual of 94 evaluable participants within 16 months. This estimate accounts for eligible individuals who may refuse based on the distance required to travel for testing and/or treatments at OSU. We plan for expected attrition of participants before they are randomized to one of the two arms and between surgery and the primary timepoint.
Pre-assignment details
Long wait times (8-10 weeks) are common between the clinic visit when participants are enrolled and scheduled surgery date, and it is also common for surgeries to get postponed because of various medical reasons. During this time period some participants lost interest in the study and decided to withdraw. Enrolled participants who were found to have hernia widths \< 2.0cm during surgery were withdrawn before assignment. For these reasons, 26 enrolled participants withdrew before group assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.38 years STANDARD_DEVIATION 10.09 |
| Body Mass Index | 32.73 kg/m^2 STANDARD_DEVIATION 5.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| European Hernia Society Width Category W1 | 27 Participants |
| European Hernia Society Width Category W2 | 16 Participants |
| European Hernia Society Width Category W3 | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 94 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 33 Participants |
| Sex/Gender, Customized Choose not to disclose | 1 Participants |
| Sex/Gender, Customized Female | 23 Participants |
| Sex/Gender, Customized Male | 33 Participants |
| Sex/Gender, Customized Other | 0 Participants |
| Sex/Gender, Customized Transgender female (M to F) | 0 Participants |
| Sex/Gender, Customized Transgender male (F to M) | 0 Participants |
| transverse hernia width | 6.72 centimeters STANDARD_DEVIATION 6.26 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 55 |
| other Total, other adverse events | 1 / 57 | 0 / 55 |
| serious Total, serious adverse events | 0 / 57 | 0 / 55 |
Outcome results
None listed