Effect of Abdominal Exercises and Russian Stimulation on The Abdominal Muscles Strength After Abdominoplasty

NCT ID: NCT04712331

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate the effect of preoperative graduated abdominal exercises and Russian stimulation on the abdominal muscles' strength after abdominoplasty

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To investigate the effect of preoperative graduated abdominal exercises and Russian stimulation on the abdominal muscles' strength after abdominoplasty. Sixty patients will undergo abdominoplasty, their age ranged from 20 to 45 years, they were randomly distributed into four equal groups. The ultrasonography was used to evaluate abdominal muscle thickness as indicator for muscle strength at 4 occasions, initial assessment, pre-operative assessment, 2 months post-operative assessment, and finally 4 months post-operative assessment). For study group (A); received graduated abdominal exercises, group (B); received Russian stimulation on abdominal muscles, group (c); received combination between graduated abdominal exercises and Russian stimulation on abdominal muscles, the study groups received the treatment protocol for 30 min., 3 times per week for 6 weeks preoperatively for control group (D); were instructed to presume in normal activities of daily living preoperatively

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominoplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Sixty patients will undergo abdominoplasty, their age ranged from 20 to 45 years, they were randomly distributed into four equal groups. The ultrasonography was used to evaluate abdominal muscle thickness as indicator for muscle strength at 4 occasions, initial assessment, pre-operative assessment, 2 months post-operative assessment, and finally 4 months post-operative assessment). For study group (A); received graduated abdominal exercises, group (B); received Russian stimulation on abdominal muscles, group (c); received combination between graduated abdominal exercises and Russian stimulation on abdominal muscles, the study groups received the treatment protocol for 30 min., 3 times per week for 6 weeks preoperatively for control group (D); were instructed to presume in normal activities of daily living preoperatively
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: groups (A) \& (B) \& (C) ( three study groups ) and group (D) ( control group )

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The Study group A

they received graduated abdominal strengthening exercises for 30 min., 3 times per week for 6 weeks preoperatively.

Group Type EXPERIMENTAL

Graduated abdominal strengthening exercises

Intervention Type OTHER

Graduated abdominal strengthening exercises

In this study the following equipments will be used to achieve treatment approaches:

Exercise mat and inflatable Swiss ball 55 cm \& 65 cm diameter. Wall bar, wedges, elastic tubing (Thera-band) with resistance ranges from light to very heavy (yellow, red, blue, green, and gray colors).

The Study group B

they received Russian stimulation on abdominal muscles for 30 min., 3 times per week for 6 weeks preoperatively.

Group Type EXPERIMENTAL

The Russian current stimulation

Intervention Type DEVICE

The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.

The Study group C

they received combination between graduated abdominal strengthening exercises and Russian stimulation on abdominal muscles for 30 min., 3 times per week for 6 weeks preoperatively.

Group Type EXPERIMENTAL

Combination Product: Graduated abdominal strengthening exercises and the Russian current stimulation

Intervention Type OTHER

Graduated abdominal strengthening exercises and the Russian current stimulation

In this study the following equipments will be used to achieve treatment approaches:

Exercise mat and inflatable Swiss ball 55 cm \& 65 cm diameter. Wall bar, wedges, elastic tubing (Thera-band) with resistance ranges from light to very heavy (yellow, red, blue, green, and gray colors).

The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.

The Control group D

they were instructed to presume in normal activities of daily living preoperatively, without abdominal exercises or Russian stimulation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Graduated abdominal strengthening exercises

Graduated abdominal strengthening exercises

In this study the following equipments will be used to achieve treatment approaches:

Exercise mat and inflatable Swiss ball 55 cm \& 65 cm diameter. Wall bar, wedges, elastic tubing (Thera-band) with resistance ranges from light to very heavy (yellow, red, blue, green, and gray colors).

Intervention Type OTHER

The Russian current stimulation

The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.

Intervention Type DEVICE

Combination Product: Graduated abdominal strengthening exercises and the Russian current stimulation

Graduated abdominal strengthening exercises and the Russian current stimulation

In this study the following equipments will be used to achieve treatment approaches:

Exercise mat and inflatable Swiss ball 55 cm \& 65 cm diameter. Wall bar, wedges, elastic tubing (Thera-band) with resistance ranges from light to very heavy (yellow, red, blue, green, and gray colors).

The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age range between 20-45 years. All patients desire an elective surgical repair.
* All patients were diagnosed with ventral hernia based on surgeon assessment.
* All patients will participate in the study.
* All patients enrolled to the study will have their informed consent.
* All patients are able to act in abdominal training program.
* All patients are able to follow orders during testing and training times.

Exclusion Criteria

* A strangulated hernia.
* History of surgical interference (abdominal surgery) less than one year.
* Liver cirrhosis with or without ascites.
* Hip or spine deformities or contractures.
* Bowel obstruction, peritonitis, or perforation.
* Local or systemic infection.
* Patient is pregnant or intended to become pregnant during this period.
* Patient has indication for urgent surgery determinate by surgeon.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

South Valley University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammed E. Ali, Ph. D Candidate.

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohammed E. Ali, Ph.D student

Role: PRINCIPAL_INVESTIGATOR

South Valley University

Ayman M. Elmakaky

Role: PRINCIPAL_INVESTIGATOR

South Valley University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

South Valley University, Faculty of Physical Therapy

Qina, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

de Vries CEE, Klassen AF, Hoogbergen MM, Alderman AK, Pusic AL. Measuring Outcomes in Cosmetic Abdominoplasty: The BODY-Q. Clin Plast Surg. 2020 Jul;47(3):429-436. doi: 10.1016/j.cps.2020.03.003. Epub 2020 Apr 17.

Reference Type RESULT
PMID: 32448479 (View on PubMed)

Le Roy B, Selvy M, Slim K. The concept of prehabilitation: What the surgeon needs to know? J Visc Surg. 2016 Apr;153(2):109-12. doi: 10.1016/j.jviscsurg.2016.01.001. Epub 2016 Feb 3.

Reference Type RESULT
PMID: 26851994 (View on PubMed)

Knight KA, Moug SJ, West MA. Systematic review: the impact of exercise on mesenteric blood flow and its implication for preoperative rehabilitation. Tech Coloproctol. 2017 Mar;21(3):185-201. doi: 10.1007/s10151-017-1589-9. Epub 2017 Feb 27.

Reference Type RESULT
PMID: 28243813 (View on PubMed)

Valkenet K, van de Port IG, Dronkers JJ, de Vries WR, Lindeman E, Backx FJ. The effects of preoperative exercise therapy on postoperative outcome: a systematic review. Clin Rehabil. 2011 Feb;25(2):99-111. doi: 10.1177/0269215510380830. Epub 2010 Nov 8.

Reference Type RESULT
PMID: 21059667 (View on PubMed)

Park SH, Hwangbo G. Effects of combined application of progressive resistance training and Russian electrical stimulation on quadriceps femoris muscle strength in elderly women with knee osteoarthritis. J Phys Ther Sci. 2015 Mar;27(3):729-31. doi: 10.1589/jpts.27.729. Epub 2015 Mar 31.

Reference Type RESULT
PMID: 25931718 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.T.REC/012/002578

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.