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Physical Activity in IBS - a Long Term Follow up (IBS)

Primary Purpose

Irritable Bowel Syndrome (IBS)

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Increased physical activity
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome (IBS) focused on measuring IBS, physical activity, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Baseline data from the previous study

Exclusion Criteria:

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

Sites / Locations

  • Dept of Internal Medicine, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Control and intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

IBS Severity Scoring System (IBS-SSS)
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 Outcome Measures

Hospital Anxiety and Depression Scale (HADS)
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.
IBS Quality of Life (IBS-QoL)
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.
Short Form 36 (SF-36)
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.
Fatigue Impacts Scale(FIS)
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'.

Full Information

First Posted
January 8, 2013
Last Updated
January 21, 2013
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01774695
Brief Title
Physical Activity in IBS - a Long Term Follow up
Acronym
IBS
Official Title
An Intervention to Improve Physical Activity in IBS Patients Has Long Term Positive Effects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)
Keywords
IBS, physical activity, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control and intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Increased physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
IBS Severity Scoring System (IBS-SSS)
Description
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.
Time Frame
Change between baseline and follow up after five years
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Change between baseline and follow up after 5 years
Title
IBS Quality of Life (IBS-QoL)
Description
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.
Time Frame
Change between baseline and follow up after 5 years
Title
Short Form 36 (SF-36)
Description
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.
Time Frame
Change between baseline and follow up after 5 years
Title
Fatigue Impacts Scale(FIS)
Description
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'.
Time Frame
Change between baseline and follow up after 5 years
Other Pre-specified Outcome Measures:
Title
Oxygen uptake
Description
The oxygen uptake was calculated from a submaximal cycle (Monark Ergomedic 839). ergometer test according to Astrand.
Time Frame
Change between baseline and at follow up after 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Baseline data from the previous study Exclusion Criteria: pregnancy organic gastrointestinal disorders cardiac disease respiratory disease
Facility Information:
Facility Name
Dept of Internal Medicine, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21206488
Citation
Johannesson E, Simren M, Strid H, Bajor A, Sadik R. Physical activity improves symptoms in irritable bowel syndrome: a randomized controlled trial. Am J Gastroenterol. 2011 May;106(5):915-22. doi: 10.1038/ajg.2010.480. Epub 2011 Jan 4.
Results Reference
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Physical Activity in IBS - a Long Term Follow up

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