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Physical Activity in IBS - a Long Term Follow up

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01774695
First received: January 8, 2013
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Irritable Bowel Syndrome (IBS)
Behavioral: Increased physical activity

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Intervention to Improve Physical Activity in IBS Patients Has Long Term Positive Effects

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • IBS Severity Scoring System (IBS-SSS) [ Time Frame: Change between baseline and follow up after five years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change between baseline and follow up after 5 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change between baseline and follow up after 5 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change between baseline and follow up after 5 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change between baseline and follow up after 5 years ] [ Designated as safety issue: No ]
    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'.


Other Outcome Measures:
  • Oxygen uptake [ Time Frame: Change between baseline and at follow up after 5 years ] [ Designated as safety issue: No ]
    The oxygen uptake was calculated from a submaximal cycle (Monark Ergomedic 839). ergometer test according to Astrand.


Enrollment: 39
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Baseline data from the previous study

Exclusion Criteria:

  • pregnancy
  • organic gastrointestinal disorders
  • cardiac disease
  • respiratory disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774695

Locations
Sweden
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
  More Information

Publications:
Responsible Party: Magnus Simrén, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01774695     History of Changes
Other Study ID Numbers: VGFOUSA-181101
Study First Received: January 8, 2013
Last Updated: January 21, 2013
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Sahlgrenska University Hospital, Sweden:
IBS
physical activity
exercise

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014