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Physical Activity in IBS - a Long Term Follow up

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01774695
Acronym
IBS
Enrollment
39
Registered
2013-01-24
Start date
2011-06-30
Completion date
2011-11-30
Last updated
2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

IBS, physical activity, exercise

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.

Interventions

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.

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Baseline data from the previous study

Exclusion criteria

* pregnancy * organic gastrointestinal disorders * cardiac disease * respiratory disease

Design outcomes

Primary

MeasureTime frameDescription
IBS Severity Scoring System (IBS-SSS)Change between baseline and follow up after five yearsThe 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

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HADS)Change between baseline and follow up after 5 yearsHADS 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 yearsThe 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 yearsSF-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 yearsThis 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

MeasureTime frameDescription
Oxygen uptakeChange between baseline and at follow up after 5 yearsThe oxygen uptake was calculated from a submaximal cycle (Monark Ergomedic 839). ergometer test according to Astrand.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026