Effect of Whole-body Vibration on Postmenopausal Constipation

Not Applicable

Not yet recruiting

• Conditions: Constipation

• Registration Number: NCT07196761
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-20
• Study First Submitted QC: 2025-09-20
• Last Update Submitted: 2025-09-20
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Study Start: 2025-10-01
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Assessment of Constipation Symptom (PAC - SYM)	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Patient Assessment of Constipation quality of life (PAC - QOL)	6 weeks	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.

Trial Locations

Locations (1)

Nouran Mohamed Sabry; 🇪🇬 Alexandria, Egypt