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Clinical Trials/NCT01774695
NCT01774695
Completed
N/A

An Intervention to Improve Physical Activity in IBS Patients Has Long Term Positive Effects

Sahlgrenska University Hospital, Sweden1 site in 1 country39 target enrollmentJune 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Irritable Bowel Syndrome (IBS)
Sponsor
Sahlgrenska University Hospital, Sweden
Enrollment
39
Locations
1
Primary Endpoint
IBS Severity Scoring System (IBS-SSS)
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Increased physical activity has in the investigators recent study been shown to improve symptoms in irritable bowel syndrome (IBS). The aim of this study was to assess the long term effects of the investigators previous intervention in IBS patients to improve physical activity. The investigators aimed to assess the long term effects on IBS symptoms as well as quality of life, fatigue, depression and anxiety.

Detailed Description

86 patients who had been included in the investigators previous study "Physical Activity Improves Symptoms in Irritable Bowel Syndrome: A Randomized Controlled Trial" were contacted and asked to participate in a long term follow up 5 years after the previous study. The subjects attended one visit at which they underwent a bicycle ergometer test to calculate the oxygen uptake and filled out questionnaires.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
November 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Responsible Party
Principal Investigator
Principal Investigator

Magnus Simrén

MD, PhD

Sahlgrenska University Hospital, Sweden

Eligibility Criteria

Inclusion Criteria

  • Baseline data from the previous study

Exclusion Criteria

  • pregnancy
  • organic gastrointestinal disorders
  • cardiac disease
  • respiratory disease

Outcomes

Primary Outcomes

IBS Severity Scoring System (IBS-SSS)

Time Frame: Change between baseline and follow up after five years

The IBS-SSS consists of visual analog scales and is divided into two subscales, an overall IBS score and an extra colonic score. The IBS score contains questions regarding pain severity, pain frequency, abdominal bloating, bowel habit dissatisfaction, and life interference. The extra colonic score contains questions regarding vomiting, gas, belching, satiety, headache, fatigue, musculoskeletal pain, heartburn, dysuria and urgency. Each subscale ranges from 0 to 500, with higher scores meaning more severe symptoms. A reduction of 50 is considered to be adequate to detect a clinical improvement.

Secondary Outcomes

  • Hospital Anxiety and Depression Scale (HADS)(Change between baseline and follow up after 5 years)
  • IBS Quality of Life (IBS-QoL)(Change between baseline and follow up after 5 years)
  • Short Form 36 (SF-36)(Change between baseline and follow up after 5 years)
  • Fatigue Impacts Scale(FIS)(Change between baseline and follow up after 5 years)

Study Sites (1)

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