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

Kaohsiung Medical University

Status: Completed

Conditions: Breast Neoplasms

Treatments: Behavioral: Abdominal muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT04886921

KMUH-IRB-970469

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 3 patient groups

TRAM abdominal muscle training group

Experimental group

Description:

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.

Treatment:

Behavioral: Abdominal muscle training

TRAM control group

No Intervention group

Description:

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. The control group was not received any exercise program.

Healthy women group

No Intervention group

Description:

A control group comprising female volunteers who were apparently healthy and had comparable socioeconomic backgrounds and physical conditions was recruited by convenience sampling from communities.