Clinical trial NCT05222477: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nocturia
Sleep Deprivation
Keywords: nocturia
sleep deprivation
sleep quality
type 2 diabetes mellitus
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Mansoura University
First posted: 2022-02-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Number of voids
timeFrame: 6 weeks
measure: Sleep quality (0 is best, 3 is worst)
timeFrame: 6 weeks
Secondary outcomes:
measure: Abdominal and pelvic floor muscle electrical activity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alkasr Alaini hospitals
Study officials:
affiliation: Cairo University
name: Hady Atef, PhD
role: PRINCIPAL_INVESTIGATOR
References: