Clinical trial NCT04886921: Women Underwent TRAM Surgery: Its Influence on Abdominal Muscle Function and the Effects of Therapeutic Exercises
Official title: Post-mastectomy Women Underwent Transverse Rectus Abdominis Musculocutaneous Flap (TRAM) Surgery: Its Influence on Abdominal Muscle Function and the Effects of Therapeutic Exercises
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 82
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The unilateral transverse rectus abdominis musculocutaneous (TRAM) flap is a major operation widely used for breast reconstruction. It is hypothesized that this surgery has the potential risk of weakening the abdominal wall because it disrupts the integrity of the rectus abdominis muscle (RA), therefore, alters the insertion of the oblique muscles and the biomechanical relationship between the RA muscle and adjacent structures. The purposes of this study were to examine the effects of the TRAM flap surgery on muscle size of abdominal muscles, strength and endurance of trunk muscles, strength and endurance of core stability, as well as the effects of therapeutic exercises on it in post-mastectomy women underwent TRAM surgery.

Detailed description: This first year of the proposed study was aimed to understand the impacts on abdominal muscle functions. We design a case-control, cross-sectional study. There were 46 women who have undergone TRAM flap and 36 age-matched healthy women. We recorded the biomechanic and electromyographic responses during voluntary limb movements and elicited by unexpected support surface translations and tilts in standing. A six-camera Qualisys motion system was used. Ground reaction forces and moments were acquired by one Kisler force plate. Surface electromyography electrodes were used to record the activity of selected trunk and limb muscles. The second year was aimed to evaluate the effects on abdominal muscle functions after 12 weeks abdominal muscle training in the TRAM women. Outcome measures were the clinical tests for trunk muscle strength, endurance and one-leg standing was also used to exam the abdominal muscle function.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults

   * Their age should be ranged between 30 - 60 years
2. TRAM flap surgery patients

   * at least 6 months after the MS pedicled TRAM flap surgery

Exclusion Criteria:

1. Healthy adults

   * a history of injury resulting in an inability to perform activities of daily living
   * scoliosis or spinal surgery
   * neurological, neuromuscular, rheumatological or systemic diseases
2. TRAM flap surgery patients

   * tumor distant metastasis
   * a history of injury resulting in an inability to perform activities of daily living
   * scoliosis or spinal surgery
   * neurological, neuromuscular, rheumatological or systemic diseases

Primary outcomes:
measure: Changes in thickness of abdominal wall muscles at 12-week
timeFrame: The assessments will be conducted 1 and 12 weeks following the intervention
measure: Changes in the cross-sectional area of the rectus abdominis muscle (RA) muscle at 12-week
timeFrame: The assessments will be conducted 1 and 12 weeks following the intervention
measure: Changes in strength of the trunk muscles at 12-week
timeFrame: The assessments will be conducted 1 and 12 weeks following the intervention
measure: Changes in endurance of the trunk muscles at 12-week
timeFrame: The assessments will be conducted 1 and 12 weeks following the intervention
measure: Changes in balanced functions at 12-week
timeFrame: The assessments will be conducted 1 and 12 weeks following the intervention
measure: Changes in muscle activity of selected trunk and limb muscles at 12-week
timeFrame: The assessments will be conducted 1 and 12 weeks following the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Medical University Department of Physical Therapy Associate Professor
name: Li-Jiun Liaw
role: STUDY_DIRECTOR
References: