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

NCT04886921 | Completed

• 1 other identifier: KMUH-IRB-970469
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

TRAM abdominal muscle training group

EXPERIMENTAL

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.

Behavioral: Abdominal muscle training

TRAM control group

NO INTERVENTION

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

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.

Interventions

Abdominal muscle training BEHAVIORAL

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.

TRAM abdominal muscle training group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults
• Their age should be ranged between 30 - 60 years
• TRAM flap surgery patients
• at least 6 months after the MS pedicled TRAM flap surgery

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Li-Jiun Liaw

  Kaohsiung Medical University Department of Physical Therapy Associate Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 14, 2021
• Study Start: February 24, 2009
• Primary Completion: September 8, 2014
• Study Completion: September 8, 2014
• Last Updated: May 14, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share