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Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes

Primary Purpose

Nocturia, Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pelvic floor exercise
Abdominal muscles exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring nocturia, sleep deprivation, sleep quality, type 2 diabetes mellitus

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female Patients have had type II diabetes mellitus for more than 5years.
  • HbA1c value from 6.5% to7.5%.
  • Sleep deprivation for more than one month.
  • Medically stable patients
  • Blood glucose level from 130 to 150
  • Patients are not pregnant
  • Body mass index is 25 to 29.9 kg / m

Exclusion Criteria:

  • Unstable medical condition.
  • On antidepressors or anxiety treatment.
  • With ant musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
  • Cushing's disease (hypercortisolism) or Addison's disease (hypocortisolism).

Sites / Locations

  • Alkasr Alaini hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pelvic floor group

Abdominal group

Arm Description

pelvic floor exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week

Abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week

Outcomes

Primary Outcome Measures

Number of voids
Number of times that the patient go for toilet per night for urination
Sleep quality (0 is best, 3 is worst)
data about sleep from Pittsburgh sleep quality index questionnaire

Secondary Outcome Measures

Abdominal and pelvic floor muscle electrical activity
Data described by the electromyograph (EMG)

Full Information

First Posted
January 10, 2022
Last Updated
April 30, 2023
Sponsor
Cairo University
Collaborators
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05222477
Brief Title
Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes
Official Title
Effect of Pelvic Floor Versus Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Nocturia is the leading cause of sleep disruption with its subsequent negative impact on general health and QoL for a large proportion of the adult population. Nocturia is prevalent in men and women of all ages but may be particularly bothersome in younger adults, in whom the consequences of sleep disturbance may be more detrimental for daytime functioning and possibly for health and mortality.The underlying causes of nocturia obviously influence the efficacy of different treatment options. Because a major cause of nocturia is overproduction of urine at night, nocturia may not respond to treatments designed to reduce urgency and increase bladder capacity or increase urine flow, such as agents for the management of bladder outlet obstruction.
Detailed Description
Nocturia may be more than simply a patient inconvenience, in view of its association with increased risk of morbidity and mortality. Clinicians often underestimate the consequences of nocturia, however, and thus fail to perform a thorough evaluation of the condition and its causes. Patients with nocturia deserve full consultation and implementation of an appropriate management strategy to ensure that the specific underlying medical conditions associated with nighttime voiding are addressed. Investigators should help women with nocturia as to improve their sleep. Participants will strengthen their pelvic floor muscles and abdominal muscles to control voiding so their sleep will not disturb to decrease their sufferance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia, Sleep Deprivation
Keywords
nocturia, sleep deprivation, sleep quality, type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor group
Arm Type
Active Comparator
Arm Description
pelvic floor exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week
Arm Title
Abdominal group
Arm Type
Active Comparator
Arm Description
Abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week
Intervention Type
Behavioral
Intervention Name(s)
pelvic floor exercise
Intervention Description
pelvic floor exercises(intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week
Intervention Type
Behavioral
Intervention Name(s)
Abdominal muscles exercise
Intervention Description
abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week
Primary Outcome Measure Information:
Title
Number of voids
Description
Number of times that the patient go for toilet per night for urination
Time Frame
6 weeks
Title
Sleep quality (0 is best, 3 is worst)
Description
data about sleep from Pittsburgh sleep quality index questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Abdominal and pelvic floor muscle electrical activity
Description
Data described by the electromyograph (EMG)
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Nocturia is more prevalent in women with type 2 diabetes, therefore, we will include only females
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Patients have had type II diabetes mellitus for more than 5years. HbA1c value from 6.5% to7.5%. Sleep deprivation for more than one month. Medically stable patients Blood glucose level from 130 to 150 Patients are not pregnant Body mass index is 25 to 29.9 kg / m Exclusion Criteria: Unstable medical condition. On antidepressors or anxiety treatment. With ant musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise. Cushing's disease (hypercortisolism) or Addison's disease (hypocortisolism).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hady Atef, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alkasr Alaini hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are planning to share the IPD on publication
IPD Sharing Time Frame
12 months
IPD Sharing Access Criteria
We will provide this to the journal where we will submit our manuscript

Learn more about this trial

Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes

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