NCT07196761

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 20, 2025

Last Update Submit

September 20, 2025

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient Assessment of Constipation quality of life (PAC - QOL)

    6 weeks

Study Arms (2)

Bowel care advice group

ACTIVE COMPARATOR

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

Other: Bowel care advice

Whole body vibration and bowl care advice group

EXPERIMENTAL

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 adviceDevice: Whole-body vibration

Interventions

Bowel care adviceOTHER

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

Bowel care advice groupWhole body vibration and bowl care advice group
Whole-body vibrationDEVICE

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.

Whole body vibration and bowl care advice group

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Irritable bowel syndrome or anal fissures.
  • Genital organ prolapse as rectocele.
  • Any neurological diseases, spinal diseases or spinal deformities.
  • History of bowel surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nouran Mohamed Sabry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Azza Kassab, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Nouran Sabry, Master

CONTACT

01277482959Nourantemo@yahoo.com

Mohamed Abo Eleinien, Professor

CONTACT

01001414404Drfawzygyna61@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 20, 2025

First Posted

September 29, 2025

Study Start

October 1, 2025

Primary Completion

January 15, 2026

Study Completion

January 30, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations

EG(1)