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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04886921
• Other study ID #: KMUH-IRB-970469
• Status: Completed
• Phase: N/A
• Start date: February 24, 2009
• Est. completion date: September 8, 2014

Study information

• Verified date: February 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 8, 2014
• Est. primary completion date: September 8, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• Abdominal muscle training
Participants will receive 12-week, 60 minutes, 36-session abdominal muscle training in the TRAM women. 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in thickness of abdominal wall muscles at 12-week	Using the Ultrasound imaging to measure the thickness of all abdominal wall muscles at rest and in an isometric contraction.	The assessments will be conducted 1 and 12 weeks following the intervention
Primary	Changes in the cross-sectional area of the rectus abdominis muscle (RA) muscle at 12-week	Using the Ultrasound imaging to measure the cross-sectional area of the rectus abdominis muscle at rest and in an isometric contraction.	The assessments will be conducted 1 and 12 weeks following the intervention
Primary	Changes in strength of the trunk muscles at 12-week	Using the dynamometer and clinical tests (prone extension, curl-up and rotational curl-up) to measure the trunk strength	The assessments will be conducted 1 and 12 weeks following the intervention
Primary	Changes in endurance of the trunk muscles at 12-week	Using the clinical tests (abdominal muscle test for strength, unsupported double bend leg lifting for static endurance) to measure the endurance of trunk muscles	The assessments will be conducted 1 and 12 weeks following the intervention
Primary	Changes in balanced functions at 12-week	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.	The assessments will be conducted 1 and 12 weeks following the intervention
Primary	Changes in muscle activity of selected trunk and limb muscles at 12-week	Using A six-camera Qualisys motion system to measure the muscle activity of selected trunk and limb muscles.	The assessments will be conducted 1 and 12 weeks following the intervention