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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Abdominal muscle training
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Neoplasms

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    No Intervention

    No Intervention

    Arm Label

    TRAM abdominal muscle training group

    TRAM control group

    Healthy women group

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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
    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
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 11, 2021
    Last Updated
    May 11, 2021
    Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04886921
    Brief Title
    Women Underwent TRAM Surgery: Its Influence on Abdominal Muscle Function and the Effects of Therapeutic Exercises
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    February 24, 2009 (Actual)
    Primary Completion Date
    September 8, 2014 (Actual)
    Study Completion Date
    September 8, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Neoplasms

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TRAM abdominal muscle training group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    TRAM control group
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Healthy women group
    Arm Type
    No Intervention
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Abdominal muscle training
    Intervention Description
    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 Outcome Measure Information:
    Title
    Changes in thickness of abdominal wall muscles at 12-week
    Description
    Using the Ultrasound imaging to measure the thickness of all abdominal wall muscles at rest and in an isometric contraction.
    Time Frame
    The assessments will be conducted 1 and 12 weeks following the intervention
    Title
    Changes in the cross-sectional area of the rectus abdominis muscle (RA) muscle at 12-week
    Description
    Using the Ultrasound imaging to measure the cross-sectional area of the rectus abdominis muscle at rest and in an isometric contraction.
    Time Frame
    The assessments will be conducted 1 and 12 weeks following the intervention
    Title
    Changes in strength of the trunk muscles at 12-week
    Description
    Using the dynamometer and clinical tests (prone extension, curl-up and rotational curl-up) to measure the trunk strength
    Time Frame
    The assessments will be conducted 1 and 12 weeks following the intervention
    Title
    Changes in endurance of the trunk muscles at 12-week
    Description
    Using the clinical tests (abdominal muscle test for strength, unsupported double bend leg lifting for static endurance) to measure the endurance of trunk muscles
    Time Frame
    The assessments will be conducted 1 and 12 weeks following the intervention
    Title
    Changes in balanced functions at 12-week
    Description
    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.
    Time Frame
    The assessments will be conducted 1 and 12 weeks following the intervention
    Title
    Changes in muscle activity of selected trunk and limb muscles at 12-week
    Description
    Using A six-camera Qualisys motion system to measure the muscle activity of selected trunk and limb muscles.
    Time Frame
    The assessments will be conducted 1 and 12 weeks following the intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li-Jiun Liaw
    Organizational Affiliation
    Kaohsiung Medical University Department of Physical Therapy Associate Professor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Currently in the submission stage ,and then share with other researchers after publication

    Learn more about this trial

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

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