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Functional Dyspepsia Response to Relaxation Therapy and Physical Activity

Primary Purpose

Dyspepsia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
relaxation and physical activity
relaxation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia

Eligibility Criteria

40 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • perimenopausal women With FD symptoms

Exclusion Criteria:

  • other gastrointestinal disease
  • Cardiovascular, metabolic, respiratory, renal complaints
  • Pregnancy
  • Women in Lactation
  • neurological / Psychic Women

Sites / Locations

  • Faculty of Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A

Group B

Arm Description

This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose), Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time), physical activity ( five session per the week conducted on treadmill, 30 minutes in the first treatment month and 40 minutes in the second treatment month)

This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose) and Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time)

Outcomes

Primary Outcome Measures

cortisol
stress hormone will be measured in serum

Secondary Outcome Measures

Glasgow dyspepsia severity score
it is questionnaire assessing severity of dyspepsia
Visual analogue scale
it is a scale for assessment of severity of abdominal syymptoms
depression anxiety stress scales-42
it is a 42 item self-report scale designed to measure the negative emotional states of depression, anxiety and stress
Pittsburgh sleep quality index
it is a questionnaire for sleep quality assessment
Estradiol
one of endogenous estrogen in the serum of women

Full Information

First Posted
May 12, 2022
Last Updated
May 12, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05378009
Brief Title
Functional Dyspepsia Response to Relaxation Therapy and Physical Activity
Official Title
Functional Dyspepsia Response to Relaxation Therapy Alone or Combined With Physical Activity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
June 15, 2022 (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
Functional dyspepsia (FD) is a common gastrointestinal disease with high morbidity. Due to the drop in estrogen level, perimenopausal women with FD (PMFD) have an increase in emotional disorders such as depression, anxiety and sleep disorder.
Detailed Description
the research will include 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation), physical exercise (on treadmill), and proton pump inhibitors. Also, the research will include another 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation) and proton pump inhibitors

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose), Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time), physical activity ( five session per the week conducted on treadmill, 30 minutes in the first treatment month and 40 minutes in the second treatment month)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose) and Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time)
Intervention Type
Behavioral
Intervention Name(s)
relaxation and physical activity
Intervention Description
This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose), Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time), physical activity ( five session per the week conducted on treadmill, 30 minutes in the first treatment month and 40 minutes in the second treatment month)
Intervention Type
Behavioral
Intervention Name(s)
relaxation
Intervention Description
This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose) and Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time)
Primary Outcome Measure Information:
Title
cortisol
Description
stress hormone will be measured in serum
Time Frame
It will be measured after 8 weeks
Secondary Outcome Measure Information:
Title
Glasgow dyspepsia severity score
Description
it is questionnaire assessing severity of dyspepsia
Time Frame
It will be measured after 8 weeks
Title
Visual analogue scale
Description
it is a scale for assessment of severity of abdominal syymptoms
Time Frame
It will be measured after 8 weeks
Title
depression anxiety stress scales-42
Description
it is a 42 item self-report scale designed to measure the negative emotional states of depression, anxiety and stress
Time Frame
It will be measured after 8 weeks
Title
Pittsburgh sleep quality index
Description
it is a questionnaire for sleep quality assessment
Time Frame
It will be measured after 8 weeks
Title
Estradiol
Description
one of endogenous estrogen in the serum of women
Time Frame
It will be measured after 8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: perimenopausal women With FD symptoms Exclusion Criteria: other gastrointestinal disease Cardiovascular, metabolic, respiratory, renal complaints Pregnancy Women in Lactation neurological / Psychic Women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

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Functional Dyspepsia Response to Relaxation Therapy and Physical Activity

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