Physical Activity in IBS - a Long Term Follow up

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome (IBS)
• Interventions: Behavioral: Increased physical activity

• Registration Number: NCT01774695
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-09
• Study Completion: 2011-11
• Status Verified: 2013-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-21
• Last Update Submitted: 2013-01-21
• Study First Posted: 2013-01-24
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Baseline data from the previous study

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control and intervention	Increased physical activity	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.

Primary Outcome Measures

Name	Time	Method
IBS Severity Scoring System (IBS-SSS)	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 Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	Change between baseline and follow up after 5 years	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)	Change between baseline and follow up after 5 years	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)	Change between baseline and follow up after 5 years	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)	Change between baseline and follow up after 5 years	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'.

Trial Locations

Locations (1)

Dept of Internal Medicine, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden