Effect of Whole-body Vibration on Postmenopausal Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bowel care advice, Whole-body vibration.
- Who it may be relevant to
- Registry conditions: Constipation. Basic parameters: 50 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will be conducted to investigate the effect of whole-body vibration on postmenopausal constipation
Detailed description
Constipation is common in menopause with prevalence ranging from 4% to 29% in various parts of the world. The incidence of constipation among postmenopausal women has been reported to be 37.3%. It can affect the physical, mental and social well-being of women; it reduces individual productivity and creates a significant burden on society and disrupting women's quality of life.
Postmenopausal constipation needs to be treated as it can cause serious problems as hemorrhoids, anal fissures, pelvic organ prolapse and severe pain during defecation.
Laxatives can prevent constipation but its overuse may lead to dependency and decreased bowel function . Also, it may cause some side effects as rectal bleeding, bloody stools, severe cramps or pain, weakness or unusual tiredness, unexplained changes in bowel patterns, severe diarrhea, weakness or unusual tiredness.
Whole body vibration strengthens smooth muscles through oscillation, which causes muscles to rapidly contract and relax. This has been shown to significantly improve the condition of those with chronic functional constipation.
Whole body vibration can aid in minimizing the build up of toxins because it increases blood flow and prevent accumulation of wastes in the colon. Also, it improves gut microbiota that aid in digestion due to increased intestinal permeability.
Few studies have investigated the effect of whole body vibration specifically on postmenopausal woman. So, this study will be conducted to investigate the effect of the whole body vibration on functional constipation in postmenopausal women to provide an insight for the benefits of such intervention in the management of postmenopausal constipation.
Interventions
- Other Bowel care advice
It includes: - Encourage adequate fiber intake (20 to 35 grams) each day. * Avoid caffeine - containing foods and beverages * Drink at least 1.5 to 2 liters of water/day * Proper defecation position such as, sitting with knees higher than hips (use a foot stool or other flat, stable object if necessary) , lean forward and put elbows on knees, relax and bulge out the stomach and straighten the spine - Device Whole-body vibration
Crazy fit massager (made in China ) with platform surface size (65 cm X 35 cm ) base height 20 cm, heavy-duty motor wattage: 200 - 500 watts, will be used to provide whole body vibration for the participants in the experimental group, for 25 minutes, 3 times per week for 6 weeks.
Primary outcome measures
- Patient Assessment of Constipation Symptom (PAC - SYM) [Time frame: 6 weeks]
Secondary outcome measures (1)
- Patient Assessment of Constipation quality of life (PAC - QOL) [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- Fifty postmenopausal women are clinically diagnosed as having functional constipation after menopause (at least one year after stoppage of last menstrual cycle)
- Their age will be ranged from 50 to 60 years old.
- Their body mass index will not exceed 30 kg/m2.
- They will not receive any medical treatment.
- All of them should have at least two criteria of Rome III diagnostic criteria of constipation.
Exclusion criteria
- Irritable bowel syndrome or anal fissures.
- Genital organ prolapse as rectocele.
- Any neurological diseases, spinal diseases or spinal deformities.
- History of bowel surgery.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Nouran Mohamed Sabry — Alexandria
Identifiers
NCT: NCT07196761 · P.T.REC/012/005907