Effect of Whole-body Vibration on Postmenopausal Constipation

NCT ID: NCT07196761

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-01-30

Brief Summary

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bowel care advice group

The participants will receive general bowel care advice only for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Bowel care advice

Intervention Type: OTHER

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

Whole body vibration and bowl care advice group

The participants will be subjected to whole-body vibration therapy for 25-minute/session , 3 times per week for 6 weeks in addition to general bowel care advice.

Group Type: EXPERIMENTAL

Bowel care advice

Intervention Type: OTHER

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

Whole-body vibration

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nouran Mohamed Sabry

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azza Kassab, Professor

Role: STUDY_CHAIR

Cairo University

Locations

Nouran Mohamed Sabry

Alexandria, , Egypt

Countries

Egypt

Central Contacts

Nouran Sabry, Master

Role: CONTACT

Nourantemo@yahoo.com

01277482959

Mohamed Abo Eleinien, Professor

Role: CONTACT

Drfawzygyna61@gmail.com

01001414404

Other Identifiers

P.T.REC/012/005907

Identifier Type: -

Identifier Source: org_study_id