Women Underwent TRAM Surgery: Its Influence on Abdominal Muscle Function and the Effects of Therapeutic Exercises

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Behavioral: Abdominal muscle training

• Registration Number: NCT04886921
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study Start: 2009-02-24
• Primary Completion: 2014-09-08
• Study Completion: 2014-09-08
• Status Verified: 2021-02
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Study First Posted: 2021-05-14
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRAM abdominal muscle training group	Abdominal muscle training	Patients were recruited at least 6 months after the muscle-sparing (MS) pedicled Transverse rectus abdominis musculocutaneous (TRAM) flap procedure and at least 1 month after the conclusion of the last chemotherapy course, if any. All subjects will receive 1-hr training sessions consisting of core stability exercises for 12 weeks for the TRAM group.

Primary Outcome Measures

Name	Time	Method
Changes in balanced functions at 12-week	The assessments will be conducted 1 and 12 weeks following the intervention	Using the seconds in the following static position to measure the balance: one-leg standing with the other lift-leg 1 inch of ground clearance; single leg standing with the other lift-leg hip flexion 90 degrees and the tibia vertical to the floor.
Changes in the cross-sectional area of the rectus abdominis muscle (RA) muscle at 12-week	The assessments will be conducted 1 and 12 weeks following the intervention	Using the Ultrasound imaging to measure the cross-sectional area of the rectus abdominis muscle at rest and in an isometric contraction.
Changes in endurance of the trunk muscles at 12-week	The assessments will be conducted 1 and 12 weeks following the intervention	Using the clinical tests (abdominal muscle test for strength, unsupported double bend leg lifting for static endurance) to measure the endurance of trunk muscles
Changes in thickness of abdominal wall muscles at 12-week	The assessments will be conducted 1 and 12 weeks following the intervention	Using the Ultrasound imaging to measure the thickness of all abdominal wall muscles at rest and in an isometric contraction.
Changes in strength of the trunk muscles at 12-week	The assessments will be conducted 1 and 12 weeks following the intervention	Using the dynamometer and clinical tests (prone extension, curl-up and rotational curl-up) to measure the trunk strength
Changes in muscle activity of selected trunk and limb muscles at 12-week	The assessments will be conducted 1 and 12 weeks following the intervention	Using A six-camera Qualisys motion system to measure the muscle activity of selected trunk and limb muscles.