An interventional study of Physical Activity in Irritable Bowel Syndrome (IBS), sponsored by Nottingham Trent University. Not yet recruiting. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Nottingham Trent University · Not applicable, Interventional, and Treatment
This intervention study explores whether a routine physical activity intervention can help manage or relieve symptoms of Irritable Bowel Syndrome (IBS) in adults who have been clinically diagnosed with IBS. The main questions it aims to answer is:
Comparison Group: Researchers will compare the intervention group (receiving the 12-week physical activity program) with a control group (receiving no intervention for 12-weeks).
Participant Activities and Interventions:
This study investigates the effects of a structured routine physical activity intervention on symptom management in adults with irritable bowel syndrome (IBS). The intervention consists of a 12-week walking program designed to assess whether regular physical activity can reduce IBS symptom severity and improve quality of life.
Participants are assigned to either the intervention group, where they will engage in routine walking sessions, or to a control group, which will not participate in the physical activity program. The primary outcome is the reduction in IBS symptom severity compared to baseline, with secondary outcomes including quality of life (QoL) scores, anxiety, and depression levels in addition to biological markers.
Study activities include:
The study aims to provide insights into the potential benefits of physical activity as a non-pharmacological management strategy for IBS management.
1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Nottingham Trent University is the lead sponsor of 30 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Participants in this arm will engage in a structured 12-week walking program. They will complete sub-maximal fitness assessments and provide biological samples during visits to the university at baseline, week 6, and week 12. They will also complete questionnaires assessing IBS symptoms, quality of life (QoL), anxiety, depression, and other factors.
Behavioral: Physical Activity
Participants in this arm will not receive any intervention and will continue their usual lifestyle for the study duration. They will complete the same assessments as the intervention arm, including providing biological samples, undergoing sub-maximal fitness tests, and completing questionnaires at baseline, week 6, and week 12. This arm serves as a comparison group to evaluate the effects of the walking program.
This intervention involves a structured 12-week walking program designed to increase routine physical activity among participants diagnosed with IBS. The intervention focuses on moderate-intensity walking, performed regularly, in line with World Health Organisation (WHO) guidelines with the aim of relieving IBS symptoms. Key elements include: Participants will be guided to adhere to an individualised walking protocol, ensuring consistency in activity levels. Physical activity levels will be monitored using self-reported diaries and wearable activity trackers to ensure compliance. Participants will also attend three scheduled visits to the university (baseline, week 6, and week 12) for biological sample collection, sub-maximal fitness assessments, and the completion of validated questionnaires on IBS symptoms, quality of life (QoL), anxiety, and depression.
Clinically significant change in IBS Symptom Severity Score (IBS-SSS)
The primary outcome will assess changes in IBS symptom severity over the 12-week intervention using a validated measure such as the IBS Severity Scoring System (IBS-SSS). This includes self-reported symptom scores for pain, frequency of bowel disturbances, and overall impact on daily life. A scale of 0-500, with higher scores indicative of more severe symtpoms and a change in 50points indicates a clinically significant change. The categories: Healthy: 0-74 Mild IBS: 75 ≤ Score \< 175 Moderate IBS: 175 ≤ Score \< 300 Severe IBS: Score ≥ 300
Time frame: Baseline, Week 6, Week 12
Changes in Gut Microbiota Composition
Biological samples (e.g., stool) will be analysed to assess changes in gut microbiota composition. This aims to elucidate potential mechanisms underlying symptom relief associated with the intervention. Specific analyses will include: \- Characterisation of microbial diversity and abundance using next-generation sequencing (e.g., 16S rRNA sequencing).
Time frame: Baseline, Week 6, Week 12
Changes in Metabolomic Profiles
Biological samples (e.g., blood) will be analysed to assess changes in metabolomic profile. This aims to elucidate potential mechanisms underlying symptom relief associated with the intervention. Specific analyses will include: \- Identification of key metabolites and pathways involved through untargeted metabolomics.
Time frame: Baseline, Week 6, Week 12
Changes in Proteome
Biological samples (e.g., blood) will be analysed to assess changes in gut proteome profile. This aims to elucidate potential mechanisms underlying symptom relief associated with the intervention. Specific analyses will include: \- Proteomic analysis to explore systemic changes and molecular signatures linked to IBS symptom modulation.
Time frame: Baseline, Week 6, Week 12
Physical Fitness Improvement
Sub-maximal fitness tests will assess changes in participants' aerobic capacity as an indicator of physical activity levels.
Time frame: Baseline, Week 6, Week 12
Changes in Anxiety Levels
Evaluated using the Generalized Anxiety Disorder-7 (GAD-7) self report questionnaires. Participants rate how often they've experienced seven symptoms over the past two weeks, with each item scored from 0 ("Not at all") to 3 ("Nearly every day"). The total score is calculated by summing the responses, with a maximum score of 21. Higher scores indicate greater anxiety severity, categorised as follows: None: 0-4 Mild: 5-9 Moderate: 10-14 Severe: 15-21
Time frame: Baseline, Week 6, Week 12
Changes in Depression Levels
Evaluated using the Patient Health Questionnaire-8 (PHQ-8) self report questionnaires. Participants rate how often they've experienced eight symptoms over the past two weeks, with each item scored from 0 ("Not at all") to 3 ("Nearly every day"). The total score is the sum of responses, with a maximum score of 24. Higher scores indicate greater depression severity, categorised as follows: None: 0-4 Mild: 5-9 Moderate: 10-14 Moderately Severe: 15-19 Severe: 20-24
Time frame: Baseline, Week 6, Week 12
Change in Quality of Life (QoL) Scores
Assessed using a validated Short Form Health Survey (SF-36), QoL questionnaire. The SF-36 is a health survey assessing quality of life across 9 domains: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Health, Energy/Fatigue, Emotional Well-Being, Social Functioning, Pain, General Health, and Health Change. Each domain is scored from 0 to 100, with higher scores indicating better health.
Time frame: Baseline, Week 6, Week 12
No study locations are listed for this record.
Start is estimated for Mar 2025; primary completion for Dec 2025, 9 months later.
Of 297 non-industry interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 9 months is below that.
Counting every sponsor, half of 345 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Nottingham Trent University