Breast NeoplasmsNCT04886921
Women Underwent TRAM Surgery: Its Influence on Abdominal Muscle Function and the Effects of Therapeutic Exercises
A study testing Abdominal muscle training in people with Breast Neoplasms, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Abdominal muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2009to 8 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- a history of injury resulting in an inability to perform activities of daily living
- scoliosis or spinal surgery
- neurological, neuromuscular, rheumatological or systemic diseases
About this study
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
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Abdominal muscle training
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal muscle trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: The assessments will be conducted 1 and 12 weeks following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start24 Feb 2009
- Primary completion8 Sep 2014
- Study completion8 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Jiun Liaw, Study director, Kaohsiung Medical University Department of Physical Therapy Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886921
- Sponsor's protocol ID
- KMUH-IRB-970469
- Status last verified
- Feb 2021
- First submitted
- 11 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently in the submission stage ,and then share with other researchers after publication
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04886921
- Acronym / sponsor ID
- KMUH-IRB-970469
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 24 Feb 2009 (actual)
- Primary completion
- 8 Sep 2014 (actual)
- Study completion
- 8 Sep 2014 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRAM abdominal muscle training group | Experimental | Behavioral: Abdominal muscle trainingPatients 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. |
| 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults
- TRAM flap surgery patients
Key exclusion criteria (9 listed)
- Healthy adults
- TRAM flap surgery patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal muscle trainingParticipants 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. | Behavioural | TRAM abdominal muscle training group |
Primary outcome
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.
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.
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No. Currently in the submission stage ,and then share with other researchers after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Jiun Liaw study director
Kaohsiung Medical University Department of Physical Therapy Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal muscle training in people with Breast Neoplasms, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in thickness of abdominal wall muscles at 12-week (time frame: The assessments will be conducted 1 and 12 weeks following the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.