- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01774695
Physical Activity in IBS - a Long Term Follow up (IBS)
January 21, 2013 updated by: Magnus Simrén, Sahlgrenska University Hospital, Sweden
An Intervention to Improve Physical Activity in IBS Patients Has Long Term Positive Effects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gothenburg, Sweden, 41345
- Dept of Internal Medicine, Sahlgrenska University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Baseline data from the previous study
Exclusion Criteria:
- pregnancy
- organic gastrointestinal disorders
- cardiac disease
- respiratory disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control and intervention
In the first study half of the subjects first served as controls for 12 weeks and then they went through the intervention.
The other half only went through the intervention.
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The subjects were encouraged to increase their level of physical activity for 12 weeks in the previous study. The advice was individual but was based on the recommendations of the Swedish National Institute of health. The recommendation for increasing cardiorespiratory fitness is 20-60 minutes of moderate to vigorous intensive physical activity 3 to 5 days per week. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IBS Severity Scoring System (IBS-SSS)
Time Frame: Change between baseline and follow up after five years
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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.
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Change between baseline and follow up after five years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change between baseline and follow up after 5 years
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HADS was developed for medical outpatients and consists of 14 items, each using a 4-graded Likert scale (0-3).
The scale is divided into two subscales, anxiety and depression.
Each subscale ranges from 0 to 21, where high score means more severe symptoms.
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Change between baseline and follow up after 5 years
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IBS Quality of Life (IBS-QoL)
Time Frame: Change between baseline and follow up after 5 years
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The IBS-QOL is a disease specific instrument measuring HRQOL.
It consists of 30 items which measures nine dimensions; emotional functioning, mental health, sleep, energy, physical functioning, diet, social role, physical role and sexual relations.
For each subscale the scores are transformed to range from 0 to 100; 100 representing the best possible disease specific quality of life.
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Change between baseline and follow up after 5 years
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Short Form 36 (SF-36)
Time Frame: Change between baseline and follow up after 5 years
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SF-36 was used to assess the general HRQOL.
SF-36 includes 36 items which are divided into eight subscales; physical functioning, physical role, body pain, general health perceptions, vitality, social functioning, emotional role and mental health.
For each subscale the raw scores are transformed into a scale from 0 to 100, with 100 representing the best possible HRQOL.
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Change between baseline and follow up after 5 years
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Fatigue Impacts Scale(FIS)
Time Frame: Change between baseline and follow up after 5 years
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This scale was initially developed for patients with chronic fatigue syndrome and has previously been used in studies in IBS patients.11
The scale consists of 40 questions divided into three subscales, physical functioning (10 items), cognitive functioning (10 items) and psychosocial functioning (20 items).
The subjects are asked to rate to which extent fatigue has caused problems for them during the previous month.
Each item consists of a statement and the subject should rate 0 to 4 where 0 means 'no problem' and 4 means 'extreme problem'.
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Change between baseline and follow up after 5 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen uptake
Time Frame: Change between baseline and at follow up after 5 years
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The oxygen uptake was calculated from a submaximal cycle (Monark Ergomedic 839).
ergometer test according to Astrand.
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Change between baseline and at follow up after 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
January 8, 2013
First Submitted That Met QC Criteria
January 21, 2013
First Posted (Estimate)
January 24, 2013
Study Record Updates
Last Update Posted (Estimate)
January 24, 2013
Last Update Submitted That Met QC Criteria
January 21, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VGFOUSA-181101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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