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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05222477
Collaborator
Mansoura University (Other)
60
1
2
6.5
9.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: pelvic floor exercise
  • Behavioral: Abdominal muscles exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
Effect of Pelvic Floor Versus Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes
Actual Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
May 15, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

  1. Number of voids [6 weeks]

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

  2. Sleep quality (0 is best, 3 is worst) [6 weeks]

    data about sleep from Pittsburgh sleep quality index questionnaire

Secondary Outcome Measures

  1. Abdominal and pelvic floor muscle electrical activity [6 weeks]

    Data described by the electromyograph (EMG)

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alkasr Alaini hospitals Cairo Egypt

Sponsors and Collaborators

  • Cairo University
  • Mansoura University

Investigators

  • Principal Investigator: Hady Atef, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hady Atef Labib, Lecturer of physical therapy, Cairo University
ClinicalTrials.gov Identifier:
NCT05222477
Other Study ID Numbers:
  • NSQ
First Posted:
Feb 3, 2022
Last Update Posted:
Feb 3, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hady Atef Labib, Lecturer of physical therapy, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2022