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Completed

NCT Number: NCT01609608

Whole-Body Vibration for Functional Constipation

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhua Christian hospital

Changhua, Taiwan, 500

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • met the Rome III criteria of constipation

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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

    Time frame: baseline (day 1), the completion of the trial (day 14)

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 1, 2012
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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