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Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair (ABVENTURE-P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05142618
Recruitment Status : Not yet recruiting
First Posted : December 2, 2021
Last Update Posted : December 2, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ajit Chaudhari, Ohio State University

Brief Summary:
This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.

Condition or disease Intervention/treatment Phase
Ventral Hernia Hernia Herniorrhaphy Abdominal Wall Postoperative Period Physical Therapy Modalities Other: Supervised Physical Therapy Other: Post-operative Precautions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Post-operative Instructions
Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.
Other: Post-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.

Experimental: 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: Supervised Physical Therapy
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.




Primary Outcome Measures :
  1. Change from Baseline in Five times sit-to-stand time [ Time Frame: 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.

  2. Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function [ Time Frame: Baseline before surgery, 10 weeks after surgery ]
    Computer-adaptive patient-reported questionnaire asking questions about physical function.

  3. Change from Baseline in Quiet unstable sitting test [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Hernia related quality of life survey from baseline [ Time Frame: baseline before surgery, 10 weeks after surgery ]
    Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.

  2. Change in Timed Up-And-Go time from baseline [ Time Frame: 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.

  3. Change from baseline in International Physical Activity Questionnaire - Long Form [ Time Frame: baseline before surgery, 10 weeks after surgery ]
    Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.

  4. Change from baseline in Tampa Scale of Kinesiophobia - Short Form [ Time Frame: baseline before surgery, 10 weeks after surgery ]
    Self-reported questions on how fear affects desire and ability to perform physical activities.

  5. Hernia recurrence inventory [ Time Frame: 1 year after surgery ]
    Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge.

  6. Change in Hernia related quality of life survey from baseline [ Time Frame: baseline before surgery, 1 year after surgery ]
    Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.

  7. Change in Timed Up-And-Go time from baseline [ Time Frame: baseline before surgery, 1 year 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.

  8. Change from baseline in International Physical Activity Questionnaire - Long Form [ Time Frame: baseline before surgery, 1 year after surgery ]
    Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.

  9. Change from baseline in Tampa Scale of Kinesiophobia - Short Form [ Time Frame: baseline before surgery, 1 year after surgery ]
    Self-reported questions on how fear affects desire and ability to perform physical activities.

  10. Change from Baseline in Five times sit-to-stand time [ Time Frame: 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.

  11. Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function [ Time Frame: baseline before surgery, 1 year after surgery ]
    Computer-adaptive patient-reported questionnaire asking questions about physical function.

  12. Change from Baseline in Quiet unstable sitting test [ Time Frame: 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.


Other Outcome Measures:
  1. Change in Hernia related quality of life survey from baseline [ Time Frame: baseline before surgery, 30 days after surgery ]
    Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.

  2. Change in Timed Up-And-Go time from baseline [ Time Frame: baseline before surgery, 30 days 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.

  3. Change from baseline in International Physical Activity Questionnaire - Long Form [ Time Frame: baseline before surgery, 30 days after surgery ]
    Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.

  4. Change from baseline in Tampa Scale of Kinesiophobia - Short Form [ Time Frame: baseline before surgery, 30 days after surgery ]
    Self-reported questions on how fear affects desire and ability to perform physical activities.

  5. Change from Baseline in Five times sit-to-stand time [ Time Frame: baseline before surgery, 30 days after surgery ]
    From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.

  6. Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function [ Time Frame: baseline before surgery, 30 days after surgery ]
    Computer-adaptive patient-reported questionnaire asking questions about physical function.

  7. Change from Baseline in Quiet unstable sitting test [ Time Frame: baseline before surgery, 30 days 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.

  8. Change in Hernia related quality of life survey from baseline [ Time Frame: baseline before surgery, 6 months after surgery ]
    Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.

  9. Change in Timed Up-And-Go time from baseline [ Time Frame: baseline before surgery, 6 months 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.

  10. Change from baseline in International Physical Activity Questionnaire - Long Form [ Time Frame: baseline before surgery, 6 months after surgery ]
    Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.

  11. Change from baseline in Tampa Scale of Kinesiophobia - Short Form [ Time Frame: baseline before surgery, 6 months after surgery ]
    Self-reported questions on how fear affects desire and ability to perform physical activities.

  12. Change from Baseline in Five times sit-to-stand time [ Time Frame: baseline before surgery, 6 months after surgery ]
    From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.

  13. Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function [ Time Frame: baseline before surgery, 6 months after surgery ]
    Computer-adaptive patient-reported questionnaire asking questions about physical function.

  14. Change from Baseline in Quiet unstable sitting test [ Time Frame: baseline before surgery, 6 months 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  • Physical therapy or other skilled exercise intervention supervised by a medical rehabilitation professional within the past 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142618


Contacts
Layout table for location contacts
Contact: Stephanie Di Stasi, PT, PhD 614-293-4220 abventuretrial@osumc.edu
Contact: Ajit Chaudhari, PhD 614-292-0558 ajit.chaudhari@osumc.edu

Locations
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United States, Ohio
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Study Documents (Full-Text)

Documents provided by Ajit Chaudhari, Ohio State University:
Informed Consent Form  [PDF] October 12, 2021

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Responsible Party: Ajit Chaudhari, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT05142618    
Other Study ID Numbers: 2021H0336
R01DK131207 ( U.S. NIH Grant/Contract )
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only de-identified data will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ajit Chaudhari, Ohio State University:
ventral hernia repair
abdominal core health
physical therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal