Whole-Body Vibration for Functional Constipation

NCT01609608 | Completed DMC

• 1 other identifier: 091004
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• change from baseline in constipation severity instrument (CSI) at 2 weeks

  baseline (day 1), the completion of the trial (day 14)

Secondary Outcomes (1)

• change from baseline in health-related quality of life (HRQOL) at 2 weeks

  baseline (day 1), the completion of the trial (day 14)

Study Arms (2)

vibration

EXPERIMENTAL

Procedure: whole body vibration

placebo

PLACEBO COMPARATOR

Procedure: whole body vibration

Interventions

whole body vibration PROCEDURE

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

placebo; vibration

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• met the Rome III criteria of constipation

You may not qualify if:

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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian hospital

Changhua, Taiwan, 500, Taiwan

Location

Related Publications (2)

• 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.2008.07.004. Epub 2008 Aug 12.

  PMID: 18762281 RESULT

• Wu TJ, Wei TS, Chou YH, Yang CP, Wu CL, Chen YC, Liu SY. Whole-body vibration for functional constipation: a single-centre, single-blinded, randomized controlled trial. Colorectal Dis. 2012 Nov;14(11):e779-85. doi: 10.1111/codi.12021.

  PMID: 22966839 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: June 1, 2012
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

TW (1)