Whole-Body Vibration for Functional Constipation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tsung Ju Wu, Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT01609608
First received: May 28, 2012
Last updated: May 30, 2012
Last verified: May 2012
  Purpose
  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.

Condition Intervention
Constipation
Procedure: whole body vibration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Whole-Body Vibration for Functional Constipation: A Single-Center, Single-Blinded, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Changhua Christian Hospital:

Primary Outcome Measures:
  • change from baseline in constipation severity instrument (CSI) at 2 weeks [ Time Frame: baseline (day 1), the completion of the trial (day 14) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vibration 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
Placebo Comparator: placebo 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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • met the Rome III criteria of constipation

Exclusion Criteria:

  • pregnant
  • cardiovascular disease
  • cerebrovascular disease
  • recently undergone major surgery
  • hypothyroidism
  • depressive disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609608

Locations
Taiwan
Changhua Christian hospital
Changhua, Taiwan, 500
Sponsors and Collaborators
Changhua Christian Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tsung Ju Wu, Medical doctor, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01609608     History of Changes
Other Study ID Numbers: 091004
Study First Received: May 28, 2012
Last Updated: May 30, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014