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

Effect of Pelvic Floor Versus Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Sleep Deprivation; Nocturia
• Intervention / Treatment: Behavioral: pelvic floor exercise; Behavioral: Abdominal muscles exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hady Atef, PhD; Phone Number: +201119699110; Email: hady612@hotmail.com
• Study Contact Backup: Name: Nisma Sallam; Phone Number: +201115183616

Study Locations

• Egypt
  • Cairo, Egypt
    • Alkasr Alaini hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pelvic floor group; pelvic floor exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week	Behavioral: pelvic floor exercise; pelvic floor exercises(intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week
Active Comparator: Abdominal group; Abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week	Behavioral: Abdominal muscles exercise; abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of voids	Number of times that the patient go for toilet per night for urination	6 weeks
Sleep quality (0 is best, 3 is worst)	data about sleep from Pittsburgh sleep quality index questionnaire	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal and pelvic floor muscle electrical activity	Data described by the electromyograph (EMG)	6 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Mansoura University
• Investigators: Principal Investigator: Hady Atef, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 22, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; sleep deprivation; sleep quality; nocturia
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Sleep Deprivation; Nocturia
• Other Study ID Numbers: NSQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No