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Whole-Body Vibration for Functional Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
whole body vibration
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • met the Rome III criteria of constipation

Exclusion Criteria:

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

Sites / Locations

  • Changhua Christian hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vibration

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2012
Last Updated
May 30, 2012
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01609608
Brief Title
Whole-Body Vibration for Functional Constipation
Official Title
Whole-Body Vibration for Functional Constipation: A Single-Center, Single-Blinded, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vibration
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
whole body vibration
Intervention Description
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
Primary Outcome Measure Information:
Title
change from baseline in constipation severity instrument (CSI) at 2 weeks
Time Frame
baseline (day 1), the completion of the trial (day 14)
Secondary Outcome Measure Information:
Title
change from baseline in health-related quality of life (HRQOL) at 2 weeks
Time Frame
baseline (day 1), the completion of the trial (day 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: met the Rome III criteria of constipation Exclusion Criteria: pregnant cardiovascular disease cerebrovascular disease recently undergone major surgery hypothyroidism depressive disorder.
Facility Information:
Facility Name
Changhua Christian hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18762281
Citation
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.
Results Reference
result
PubMed Identifier
22966839
Citation
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.
Results Reference
derived

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Whole-Body Vibration for Functional Constipation

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