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

Not Applicable

Completed

• Conditions: Sleep Deprivation; Nocturia
• Interventions: Behavioral: pelvic floor exercise; Behavioral: Abdominal muscles exercise

• Registration Number: NCT05222477
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2021-11-15
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-22
• Study First Posted: 2022-02-03
• Primary Completion: 2022-05-15
• Study Completion: 2022-06-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-30
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic floor group	pelvic floor exercise	pelvic floor exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week
Abdominal group	Abdominal muscles exercise	Abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Abdominal and pelvic floor muscle electrical activity	6 weeks	Data described by the electromyograph (EMG)

Trial Locations

Locations (1)

Alkasr Alaini hospitals; 🇪🇬 Cairo, Egypt