Whole-Body Vibration for Functional Constipation

Not Applicable

Completed

• Conditions: Constipation

• Registration Number: NCT01609608
• Lead Sponsor: Changhua Christian Hospital

Brief Summary

1. Aim: The aim of this trial was to determine whether whole-body vibration (WBV) induced via a non-invasive oscillation platform could improve symptoms and health-related quality of life (HRQOL) in patients with chronic functional constipation.

2. Methods: A single-blinded, randomized, control trial was performed in a single Hospital in Taiwan. Patients diagnosed with chronic functional constipation, as per the Rome III diagnostic criteria were included and randomized to either the WBV treatment or no treatment (control) group. The treatment group received six 15-minute sessions of WBV therapy over a two-week period. Patients received vibrations of 2 mm in amplitude at a frequency of 12 Hz. The primary outcome was assessed by the constipation severity instrument (CSI). The secondary outcome was improvements in HRQOL.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Status Verified: 2012-05
• Study First Submitted: 2012-05-28
• Study First Submitted QC: 2012-05-30
• Last Update Submitted: 2012-05-30
• Study First Posted: 2012-06-01
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• met the Rome III criteria of constipation

Exclusion Criteria

• pregnant
• cardiovascular disease
• cerebrovascular disease
• recently undergone major surgery
• hypothyroidism
• depressive disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change from baseline in constipation severity instrument (CSI) at 2 weeks	baseline (day 1), the completion of the trial (day 14)

Secondary Outcome Measures

Name	Time	Method
change from baseline in health-related quality of life (HRQOL) at 2 weeks	baseline (day 1), the completion of the trial (day 14)

Trial Locations

Locations (1)

Changhua Christian hospital; 🇨🇳 Changhua, Taiwan