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Completed

NCT Number: NCT04886921

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

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.

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Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Changes in thickness of abdominal wall muscles at 12-week

    Time frame: 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.

  2. Changes in the cross-sectional area of the rectus abdominis muscle (RA) muscle at 12-week

    Time frame: 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.

  3. Changes in strength of the trunk muscles at 12-week

    Time frame: 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

  4. Changes in endurance of the trunk muscles at 12-week

    Time frame: 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

  5. Changes in balanced functions at 12-week

    Time frame: 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.

  6. Changes in muscle activity of selected trunk and limb muscles at 12-week

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

Post-mastectomy Women Underwent Transverse Rectus Abdominis Musculocutaneous Flap (TRAM) Surgery: Its Influence on Abdominal Muscle Function and the Effects of Therapeutic Exercises

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 14, 2021
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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