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

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222477
• Other study ID #: NSQ
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Nocturia
• Sleep Deprivation

Intervention

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

Locations

Country	Name	City	State
Egypt	Alkasr Alaini hospitals	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of voids	Number of times that the patient go for toilet per night for urination	6 weeks
Primary	Sleep quality (0 is best, 3 is worst)	data about sleep from Pittsburgh sleep quality index questionnaire	6 weeks
Secondary	Abdominal and pelvic floor muscle electrical activity	Data described by the electromyograph (EMG)	6 weeks