Effect of Whole-body Vibration on Postmenopausal Constipation

This study will be conducted to investigate the effect of whole-body vibration on postmenopausal constipation

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation
• Intervention / Treatment: Other: Bowel care advice; Device: Whole-body vibration

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nouran Sabry, Master; Phone Number: 01277482959; Email: Nourantemo@yahoo.com
• Study Contact Backup: Name: Mohamed Abo Eleinien, Professor; Phone Number: 01001414404; Email: Drfawzygyna61@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Nouran Mohamed Sabry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bowel care advice group; The participants will receive general bowel care advice only for 6 weeks.	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
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment of Constipation Symptom (PAC - SYM)	It is a reliable and valid tool to measure the patient's perspective constipation symptoms in terms of frequency and severity. It is a 12- item that is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Like scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment of Constipation quality of life (PAC - QOL)	The PAC-QOL questionnaire is used to evaluate the quality of life of patients having constipation. It is a brief but comprehensive tool which evaluates constipation through daily individual health assessment and functioning. This questionnaire consists of 28 self-reported items which subcategorized into 4 items on physical discomfort. 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. The overall score ranges from 0 -16. The higher the score, the higher the quality of life.	6 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Azza Kassab, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: September 20, 2025
• First Submitted That Met QC Criteria: September 20, 2025
• First Posted (Estimated): September 29, 2025

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 20, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation
• Other Study ID Numbers: P.T.REC/012/005907

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No