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Effect of Pilates Exercises on Patients With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
( Traditional dietary advice )
(Pilates exercises)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: They will be under medical supervision. Age between 20 to 45 years.). Ability to perform exercises. Diagnosis of IBS will be based on Rome IV Diagnostic criteria. Baseline irritable bowel syndrome severity score (moderate to severe)>174 Exclusion Criteria: Organic gastrointestinal disorders or other organic disease hindering physical activity. Treatment with steroids, antibiotics, immunosuppressants for at least 6 months before the beginning of the study. A history of resection of the stomach, small intestine, or large intestine (excluding hernia repair, appendectomy (> 3 months) or resection of benign polyps). Concurrent infectious enteritis, hyperthyroidism, hypothyroidism, or other diseases that may affect gastrointestinal transit or colonic function. History or current evidence of abuse of drugs or alcohol within the previous year. Malignant tumors. Concurrent serious cardiovascular, respiratory, renal, hepatic, gastrointestinal (excluding IBS). Fibromyalgia -

Sites / Locations

  • faculty of physical therapy, Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Group ( Traditional dietary advice)

Group (Pilates and traditional dietary advice )

Arm Description

Each patient will follow traditional dietary advice only for 8 weeks. Compliance of the patient to the diet will be assessed using regular telephone calls.

Patients in this group will participate in an 8-week Pilates exercise program, 2 times per week for 16 sessions, and will follow traditional dietary advice. Warming up and cooling down stretches for 5 minutes will be considered before and after exercise for the safety of the patients.

Outcomes

Primary Outcome Measures

change of selected inflammatory biomarker level (tumor necrosis factor alpha )
Serum levels of tumor necrosis factor alpha (TNFα) will be measured using an enzyme-linked immunosorbent assay (ELISA)
change of oxidative stress level (malondialdehyde MDA )
Tiobarbituric acid method will be used for measuring serum malondialdehyde (MDA) level

Secondary Outcome Measures

Bowel movement and consistency
Bristol stool form scale will be used to record bowel movements. The patients will record all bowel movements and its consistency The scale ranges from 1 to 7, where type 1 and 2 is hard and lumpy stools and type 6 and 7 is loose and watery stools
Irritable bowel syndrome symptom severity
IBS-SSS is a patient-based scale that assesses 5 clinically relevant items during a 10-day period: (1) severity of abdominal pain, (2) frequency of abdominal pain, (3) severity of abdominal distention or tightness, (4) dissatisfaction with bowel habits, and (5) interference of IBS with life in general. Each item is scored on a visual analogue scale (VAS) from 0 to 100, yielding overall scores ranging from 0 to 500 (a higher score indicates worse condition). A reduction of 50 in the IBS-score is adequate to detect a clinical improvement
Anxiety and depression
Hospital Anxiety and Depression Scale(HADS), the HADS includes 14 items assessing anxiety (7-item) and depression (7-item), which are rated on a 4-point Likert-type (from 0 to 3).A score of 0-7 is considered as normal, 8-10 as a borderline case, and 11-21 as a case (anxiety or depression)
IBS-quality of life (
IBS-quality of life questionnaire as a 34-items instrument was also developed and validated to assess QOL impairment in IBS. Each item is rated on a 5-point Likert scale (1 = not at all, 2 = slightly, 3 = moderately, 4 = quite a bit, 5 = extremely or a great deal) where 1 generally represents better responses on items and 5 represents worse responses;
Fatigue
modified Fatigue Impact Scale, a multidimensional scale developed to assess the perceived impact of fatigue on a variety of daily activities. These scores are designed to measure the disability associated with fatigue (the extent to which fatigue limits activities), not the severity of symptoms. MFIS total score ranges from 0 to 20, with the following ranges reflecting how often the person is limited in activities by fatigue: 0 -5 (never), 6 -9 (rarely), 10-14 (sometimes), 15-19 (often) and 20 (almost always).

Full Information

First Posted
March 29, 2023
Last Updated
September 26, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05832801
Brief Title
Effect of Pilates Exercises on Patients With Irritable Bowel Syndrome
Official Title
Effect of Pilates Exercises on Selected Inflammatory and Oxidative Stress Biomarkers in Patients With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
purpose: to investigate the effect of pilates exercises on patients with irritable bowel syndrome. Methods fifty patients with IBS will be recruited and randomly assigned into two groups, group A and group B. Patients in both groups will receive a traditional dietary advice for IBS, but group A will receive additional pilates exercises. All patients will be evaluated pre and post treatment for Laboratory investigation for (TNFα and MDA),Bristol stool form , Irritable bowel syndrome symptoms ,quality of life, anxiety and depression and Fatigue.
Detailed Description
A) Procedures for evaluation: The practical section of the study will be undertaken in 8 weeks (2 sessions a week). Measurement will be taken before the start of treatment program then after the end of 8 weeks treatment program in the following manner: Laboratory investigations for TNFα and MDA: Blood samples will be collected after an 8-12 h overnight fasting. For each sample, 5 mL of blood will be drawn. Serums will be frozen at -20 °C immediately and then stored at -80 °C until further laboratory analyses were carried out. Bristol stool form scale: The patients will record all bowel movements and its consistency Irritable bowel syndrome symptom severity score (IBS-SSS) will be used to measure severity of IBS symptoms The hospital anxiety and depression scale will be used to assess depression and anxiety IBS-quality of life (IBS-QOL): will be used to assess QOL impairment in IBS. Modified Fatigue Impact scale (MFIS): was developed to assess the perceived impact of fatigue on a variety of daily activities. B-Treatment procedures: All patients in both groups will be instructed to follow traditional dietary advice for IBS which is based on guidance provided by the National Institute for Health and Care Excellence (NICE ) and the British Dietetic Association (BDA). . Group (A) Patients in this group will participate in an 8-week Pilates exercise program, 2 times per week for 16 sessions, and will follow traditional dietary advice for IBS. Warming up and cooling down stretches for 5 minutes will be considered before and after exercise for the safety of the patients. Group (B) Each patient will follow traditional dietary advice for IBS which is based on guidance provided by the National Institute for Health and Care Excellence (NICE ) and the British Dietetic Association (BDA). C)Data analysis: Statistical analysis will be performed through the statistical package for social studies (SPSS) version 24 for windows. Descriptive statistics will be conducted to describe the data. Mixed-Model ANOVA will be used to determine the within-group changes and the between-group difference. The level of significance for all statistical tests will be set at p<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly assigned into two groups, group A and group B .Patients in both groups will receive a traditional dietary advice for IBS, but group (A) will receive additional pilates exercises.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group ( Traditional dietary advice)
Arm Type
Other
Arm Description
Each patient will follow traditional dietary advice only for 8 weeks. Compliance of the patient to the diet will be assessed using regular telephone calls.
Arm Title
Group (Pilates and traditional dietary advice )
Arm Type
Experimental
Arm Description
Patients in this group will participate in an 8-week Pilates exercise program, 2 times per week for 16 sessions, and will follow traditional dietary advice. Warming up and cooling down stretches for 5 minutes will be considered before and after exercise for the safety of the patients.
Intervention Type
Other
Intervention Name(s)
( Traditional dietary advice )
Intervention Description
traditional dietary advice for IBS which is based on guidance provided by the National Institute for Health and Care Excellence (NICE ) and the British Dietetic Association (BDA). Its principles include adopting healthy, sensible eating patterns such as having regular meals, never eating too little/too much, maintaining adequate hydration, and reducing the intake of (1) alcohol/caffeine/fizzy drinks, (2) fatty/spicy/processed foods, (3) fresh fruit to a maximum of 3 per day, (4) fiber and other commonly consumed gas-producing foods (eg, beans, bread, sweeteners, etc), and (5) addressing any perceived food intolerances (eg, dairy).
Intervention Type
Other
Intervention Name(s)
(Pilates exercises)
Intervention Description
Pilates exercises will be in the form of Swan, One leg up-down, Leg circles, Single leg stretch, Saw, Side kicks, The hundred,. Pelvic lift on the ball, Sit-ups with the ball, Stretching on the ball. exercise Dose will be First month (1st-8th session) 1 set of 8 repetitions Second month (8th-16th session) 2 sets of 10 repetitions
Primary Outcome Measure Information:
Title
change of selected inflammatory biomarker level (tumor necrosis factor alpha )
Description
Serum levels of tumor necrosis factor alpha (TNFα) will be measured using an enzyme-linked immunosorbent assay (ELISA)
Time Frame
(change from baseline TNFα level at 8 weeks)
Title
change of oxidative stress level (malondialdehyde MDA )
Description
Tiobarbituric acid method will be used for measuring serum malondialdehyde (MDA) level
Time Frame
(change from baseline MDA level at 8 weeks)
Secondary Outcome Measure Information:
Title
Bowel movement and consistency
Description
Bristol stool form scale will be used to record bowel movements. The patients will record all bowel movements and its consistency The scale ranges from 1 to 7, where type 1 and 2 is hard and lumpy stools and type 6 and 7 is loose and watery stools
Time Frame
(at baseline and after 8 weeks)
Title
Irritable bowel syndrome symptom severity
Description
IBS-SSS is a patient-based scale that assesses 5 clinically relevant items during a 10-day period: (1) severity of abdominal pain, (2) frequency of abdominal pain, (3) severity of abdominal distention or tightness, (4) dissatisfaction with bowel habits, and (5) interference of IBS with life in general. Each item is scored on a visual analogue scale (VAS) from 0 to 100, yielding overall scores ranging from 0 to 500 (a higher score indicates worse condition). A reduction of 50 in the IBS-score is adequate to detect a clinical improvement
Time Frame
(at baseline and after 8 weeks)
Title
Anxiety and depression
Description
Hospital Anxiety and Depression Scale(HADS), the HADS includes 14 items assessing anxiety (7-item) and depression (7-item), which are rated on a 4-point Likert-type (from 0 to 3).A score of 0-7 is considered as normal, 8-10 as a borderline case, and 11-21 as a case (anxiety or depression)
Time Frame
(at baseline and after 8 weeks)
Title
IBS-quality of life (
Description
IBS-quality of life questionnaire as a 34-items instrument was also developed and validated to assess QOL impairment in IBS. Each item is rated on a 5-point Likert scale (1 = not at all, 2 = slightly, 3 = moderately, 4 = quite a bit, 5 = extremely or a great deal) where 1 generally represents better responses on items and 5 represents worse responses;
Time Frame
(at baseline and after 8 weeks)
Title
Fatigue
Description
modified Fatigue Impact Scale, a multidimensional scale developed to assess the perceived impact of fatigue on a variety of daily activities. These scores are designed to measure the disability associated with fatigue (the extent to which fatigue limits activities), not the severity of symptoms. MFIS total score ranges from 0 to 20, with the following ranges reflecting how often the person is limited in activities by fatigue: 0 -5 (never), 6 -9 (rarely), 10-14 (sometimes), 15-19 (often) and 20 (almost always).
Time Frame
(at baseline and after 8 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: They will be under medical supervision. Age between 20 to 45 years.). Ability to perform exercises. Diagnosis of IBS will be based on Rome IV Diagnostic criteria. Baseline irritable bowel syndrome severity score (moderate to severe)>174 Exclusion Criteria: Organic gastrointestinal disorders or other organic disease hindering physical activity. Treatment with steroids, antibiotics, immunosuppressants for at least 6 months before the beginning of the study. A history of resection of the stomach, small intestine, or large intestine (excluding hernia repair, appendectomy (> 3 months) or resection of benign polyps). Concurrent infectious enteritis, hyperthyroidism, hypothyroidism, or other diseases that may affect gastrointestinal transit or colonic function. History or current evidence of abuse of drugs or alcohol within the previous year. Malignant tumors. Concurrent serious cardiovascular, respiratory, renal, hepatic, gastrointestinal (excluding IBS). Fibromyalgia -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba A. Abd El Ghafar, A. Professor
Phone
0 100 505 6590
Ext
02
Email
hebaelshweety@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Mahdy Ahmad, A. professor
Phone
01007056624
Ext
02
Email
ahmed.mahdy@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba A. Abd El Ghafar, A. Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
faculty of physical therapy, Cairo university
City
Giza
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Mahdi Ahmad, Assistant professor
Phone
01007056624
Ext
02
Email
ahmed.mahdy@pt.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Pilates Exercises on Patients With Irritable Bowel Syndrome

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