NCT01774695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

January 8, 2013

Last Update Submit

January 21, 2013

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

IBSphysical activityexercise

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

Other Outcomes (1)

  • Oxygen uptake

    Change between baseline and at follow up after 5 years

Study Arms (1)

Control and intervention

OTHER

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.

Behavioral: Increased physical activity

Interventions

Increased physical activityBEHAVIORAL

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.

Control and intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Baseline data from the previous study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 21206488BACKGROUND

MeSH Terms

Conditions

Irritable Bowel SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 24, 2013

Study Start

June 1, 2011

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

SE(1)