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

NCT05222477 | Completed DMC

• 1 other identifier: NSQ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturia; Sleep Deprivation

Keywords

nocturia; sleep deprivation; sleep quality; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Abdominal and pelvic floor muscle electrical activity

  6 weeks

Study Arms (2)

Pelvic floor group

ACTIVE COMPARATOR

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

Abdominal group

ACTIVE COMPARATOR

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

Behavioral: Abdominal muscles exercise

Interventions

pelvic floor exercise BEHAVIORAL

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

Pelvic floor group

Abdominal muscles exercise BEHAVIORAL

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

Abdominal group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Nocturia is more prevalent in women with type 2 diabetes, therefore, we will include only females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead
• Mansoura University: collaborator

Study Sites (1)

Alkasr Alaini hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Nocturia; Sleep Deprivation; Sleep Initiation and Maintenance Disorders; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Sleep Disorders, Intrinsic; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hady Atef, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 3, 2022
• Study Start: November 15, 2021
• Primary Completion: May 15, 2022
• Study Completion: June 1, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months
• Access Criteria: We will provide this to the journal where we will submit our manuscript

Locations

EG (1)