Whole-Body Vibration for Functional Constipation

Constipation Clinical Trial

Official title:

Whole-Body Vibration for Functional Constipation: A Single-Center, Single-Blinded, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609608
• Other study ID #: 091004
• Status: Completed
• Phase: N/A
• First received: May 28, 2012
• Last updated: May 30, 2012
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2012
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Procedure:
• whole body vibration
to deliver mechanical oscillation to individuals at various frequencies, amplitudes, and accelerations for different durations. This technique has been applied for years to enhance strength, and improve bone mineral density and balance

Locations

Country	Name	City	State
Taiwan	Changhua Christian hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Prisby RD, Lafage-Proust MH, Malaval L, Belli A, Vico L. Effects of whole body vibration on the skeleton and other organ systems in man and animal models: what we know and what we need to know. Ageing Res Rev. 2008 Dec;7(4):319-29. doi: 10.1016/j.arr.2008 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in constipation severity instrument (CSI) at 2 weeks		baseline (day 1), the completion of the trial (day 14)	No
Secondary	change from baseline in health-related quality of life (HRQOL) at 2 weeks		baseline (day 1), the completion of the trial (day 14)	No