Physical Activity in IBS - a Long Term Follow up
|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|
- 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.
- 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'.
- 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.
|Study Start Date:||June 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774695
|Dept of Internal Medicine, Sahlgrenska University Hospital|
|Gothenburg, Sweden, 41345|