Physical Activity in IBS - a Long Term Follow up

Irritable Bowel Syndrome (IBS) Clinical Trial

— IBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774695
• Other study ID #: VGFOUSA-181101
• Status: Completed
• Phase: N/A
• First received: January 8, 2013
• Last updated: January 21, 2013
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Baseline data from the previous study

Exclusion Criteria:

• pregnancy

• organic gastrointestinal disorders

• cardiac disease

• respiratory disease

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)

Intervention

Behavioral:
• Increased physical activity
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.

Locations

Country	Name	City	State
Sweden	Dept of Internal Medicine, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Johannesson E, Simrén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxygen uptake	The oxygen uptake was calculated from a submaximal cycle (Monark Ergomedic 839). ergometer test according to Astrand.	Change between baseline and at follow up after 5 years	No
Primary	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.	Change between baseline and follow up after five years	No
Secondary	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.	Change between baseline and follow up after 5 years	No
Secondary	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.	Change between baseline and follow up after 5 years	No
Secondary	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.	Change between baseline and follow up after 5 years	No
Secondary	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'.	Change between baseline and follow up after 5 years	No