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

May 11, 2021 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Post-mastectomy Women Underwent Transverse Rectus Abdominis Musculocutaneous Flap (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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TRAM abdominal muscle training group

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
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.
No Intervention: TRAM control group

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.
No Intervention: Healthy women group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
The assessments will be conducted 1 and 12 weeks following the intervention
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
The assessments will be conducted 1 and 12 weeks following the intervention
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
The assessments will be conducted 1 and 12 weeks following the intervention
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.
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
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.
The assessments will be conducted 1 and 12 weeks following the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Li-Jiun Liaw, Kaohsiung Medical University Department of Physical Therapy Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMUH-IRB-970469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently in the submission stage ,and then share with other researchers after publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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