- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07661147
Aerobic Versus Resistance Exercises on Disability After Abdominal Myomectomy (RE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Abdominal myomectomy is a classic surgery for uterine fibroids removal without removing the uterus, in line to reserve patients' fertility. Uterine fibroids are the most common uterus non-cancerous tumors with a prevalence of 70% to 80% in women. Although only 25% to 30% of women are affected by symptoms like pelvic pain, pressure, heavy menses, recurrent pregnancy loss, and infertility, it remains the leading indication for hysterectomy and a common women's health concern. No doubt that abdominal myomectomy almost recommended preserving fertility, plus alleviating uterine fibroids clinical manifestations without resorting to a hysterectomy.Recent studies have explored the combined effects of aerobic and resistance exercises as part of a comprehensive rehabilitation program. Research suggests that combining aerobic and resisted exercise training might gain superior functional benefits compared to using one exercise training program. A recent clinical trial conducted by demonstrated that combination of aerobic and resistance exercises almost represented with reduced fatigue symptoms, which resulted in better improved overall functional capacity, and earlier recovery in compared to those who engaged in only one exercise training protocol. The rationale behind this combination approach is that aerobic exercise improves cardiovascular fitness and endurance, while resistance training focuses on building muscle strength and improving muscular endurance, providing a more holistic approach to recover.
Finally, postoperative rehabilitation following myomectomy must also consider the prevention of complications such as abdominal scarring, hernias, and pelvic floor dysfunction, which can arise as a result of the surgery. Aerobic and resistance exercises have been shown to play a crucial role in minimizing these risks by promoting muscle strength, enhancing tissue healing, and improving flexibility. Research suggests that exercise can stimulate tissue remodeling and improve the elasticity of the abdominal wall, which reduces the likelihood of the formation of problematic scars or hernias. Furthermore, aerobic and resistance exercises support the pelvic floor muscles, helping to prevent dysfunction and incontinence, which are common concerns following abdominal surgeries like myomectomy. By addressing both muscular strength and flexibility, a balanced approach to rehabilitation can enhance recovery and reduce the risk of long-term complications.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: norhan khalaf, master
- Phone Number: 01018426731
- Email: Khalafnourhan.nk@gmail.com
Study Contact Backup
- Name: norhan khalaf
- Phone Number: 01018426731
- Email: Khalafnourhan.nk@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients are conscious and ambulant.
- Their ages ranged from 30-60 years old.
- All patients will be under post abdominal myomectomy (6-12 months) management program.
- All patients will not suffer from any complication post abdominal myomectomy, except weakness of abdominal muscles.
- All patients will receive and agreed to sign the informed consent form.
Exclusion Criteria:
- The patient who has cardiovascular diseases, or uncontrolled hypertension.
- The patient who has cardiac pacemakers or other implanted electronic devices.
- Uncooperative patients.
- Patients who have cardiopulmonary diseases.
- Patients who have psychic disorders.
- Patients with neuromuscular diseases.
- Pregnant female.
- Patients who have any endocrine, metabolic, renal or hepatic diseases. Patients who have an open wound at or near the treatment site.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: aeropic exercises
Thirty patients who have undergone abdominal myomectomy will receive resisted exercises program for, 3 sessions per week for 12 weeks in addition to the routine medical treatment
|
|
|
Experimental: Resistance Exercises
thirty patients who have undergone abdominal myomectomy will receive aerobic exercises program for, 3 sessions per week for 12 weeks in addition to the routine medical treatment
|
The patient will be prepared with preparatory explanations about each tool will be utilized i.e., sand bags, thera Bands, and swiss ball.Twelve exercises will be utilized for 12 weeks, three sessions/ week. The intervention will be applied by a trained physical therapist. First of all, each participant will be instructed to relax thighs, bottom and abdomen musculature.Each participant will be able to do 10 slow contractions each time, holding them for 10 seconds each with rests of 4 seconds in between. Then do not hold your breath or tighten rectus abdominis muscles at the same time. Will instruct participants to try holding each squeeze for a few seconds utilizing sand bags, thera band, and swiss balls. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional disability
Time Frame: up to 12 weeks
|
Functional Independence Measure Scale was used to assess functional disability.
it includes 18 items divided into two domains: Motor tasks (13 items) and cognitive tasks (5 items).
score (1-7) to each of the 18 items based on the patient's observed performance.-Total
FIM score range: 18 (complete dependence) to 126 (complete independence).
|
up to 12 weeks
|
|
pain intensity
Time Frame: up to 12 weeks
|
Visual analogue scale consisted of a line, usually 100mm long, the patient was instructed to place a vertical mark on to indicate his pain, ranging from no pain or discomfort (0), to the worst pain (100) that the patient could feel
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rectus abdominal muscle strength
Time Frame: up to 12 weeks
|
The manual muscle test is a valid and reliable dependent in assessment of musculoskeletal musculatures obtained using the procedure.
Each dimension is rated on a 7-point scale: 7 is complete independence, 6 is modified independence, 5 equals supervision or setup, 4 equals minimal contact assistance (client expends 75% or more of the effort), 3 is moderate assistance (client expends between 50% and 75% of the effort), 2 is maximal assistance (client expends between 25% and 50% of the effort), and 1 equals total assistance (client expends <25% of the effort).
|
up to 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/005921
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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