ClinicalTrials.gg
CompletedNCT05222477Updated May 3, 2023

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

An interventional study of pelvic floor exercise and Abdominal muscles exercise in Nocturia and Sleep Deprivation, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Nocturia
  • Sleep Deprivation

Keywords

  • nocturia
  • sleep deprivation
  • sleep quality
  • type 2 diabetes mellitus
03

In context

Nocturia

134 studies on the registry are indexed under Nocturia; 22 are open to participants now.

This study's enrollment of 60 is below the median of 71 across 108 interventional studies indexed under Nocturia.

Browse Nocturia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female Patients have had type II diabetes mellitus for more than 5years.
  • 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
  • is 25 to 29.9 kg / m

Exclusion criteria

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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Behavioralpelvic floor exercise

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

  • BehavioralAbdominal muscles exercise

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

06

What researchers measure

Primary outcomes

  1. Number of voids

    Number of times that the patient go for toilet per night for urination

    Time frame: 6 weeks

  2. Sleep quality (0 is best, 3 is worst)

    data about sleep from Pittsburgh sleep quality index questionnaire

    Time frame: 6 weeks

Secondary outcomes

  1. Abdominal and pelvic floor muscle electrical activity

    Data described by the electromyograph (EMG)

    Time frame: 6 weeks

07

Study locations

1 site
  • Alkasr Alaini hospitals
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — We are planning to share the IPD on publication

Supporting information: Study protocol

Time frame: 12 months

Access criteria: We will provide this to the journal where we will submit our manuscript

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05222477
Lead sponsor
Cairo University
Collaborators
Mansoura University
Responsible party
Hady Atef Labib (Lecturer of physical therapy, Cairo University) — Principal investigator
First posted
Feb 3, 2022
Start date
Nov 15, 2021
Primary completion
May 15, 2022
Completion
Jun 1, 2022
Last update
May 3, 2023

Study contacts

Hady Atef, PhD
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion