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Effect of DNS Exercises Training on Hypertension

Primary Purpose

Essential Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
dynamic neuromuscular stabilization training
balance exercises plus diaphragmatic breathing
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

50 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Sixty men patients with stage two essential HTN (more than 140/90 mm hg). Their age will be ranged from 50-60 years old. Body mass index (BMI) from 25 to 34.9 kg/m2. Low levels of physical activity (using the International Physical Activity Questionnaire-Short Version) (The Arabic version of the questionnaire will be used) Exclusion Criteria: Uncontrolled HTN. Diabetes mellitus. Heavy Smoker. Neurological or musculoskeletal conditions that interfere with gait Vertebrobasilar insufficiency (VBI). Use of psychotropic drugs. Impaired vision and/or hearing. Unstable medical conditions. Patients who are unable to follow verbal instructions. Participation in regular exercise training of any type in the previous 3 months.

Sites / Locations

  • Faculty of Physical TherapyRecruiting
  • Faculty of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

D. N.S

balance exercises plus diaphragmatic breathing

Arm Description

dynamic neuromuscular stabilization training methods demonstrated efficacy in improving global trunk stabilizing patterns with noted gains in extremity movement and strength

balance exercises plus diaphragmatic breathing The balance exercises is balance training while standing and walking and The patient assume a semi-Fowler's position and perform diaphragmatic breathing.

Outcomes

Primary Outcome Measures

Postural control by Biodex Balance System
The overall stability index (OSI), anteroposterior stability index (APSI), and mediolateral stability index (MLSI) are recorded with a Biodex Balance System, Postural stability test will be performed in the double leg standing position with the eyes open and closed and in the single leg standing position with the eyes open and closed on the right and left legs
balance by The Modified star excursion balance test (mSEBT)
• Patients will perform testing while barefoot, maintaining their hands on their hips and a series of single-limb squats using the non-stance limb to touch a point a maximum distance along designated lines on the ground
dynamic balance and functional mobility by Timed-Up-and-Go test (TUG)
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down while turning

Secondary Outcome Measures

Sleep quality: using The Pittsburgh Sleep Quality Index (PSQI)
It is used to determine self-reported sleep quality and sleep disturbances for the preceding month. It is a 19-item test and consists of seven components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) sleep efficiency, (5) sleep disturbance, (6) sleeping medication use and (7) daytime dysfunction.
Quality of life: using The 12 Item Short Form Health Survey (SF-12) Questionnaire
• The SF-12 consists of 12 questions that examine eight different health domains in order to determine physical and mental health. General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP) are the physical health domains. Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH) are mental health-related scales

Full Information

First Posted
June 4, 2023
Last Updated
August 15, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05900713
Brief Title
Effect of DNS Exercises Training on Hypertension
Official Title
Effect of Dynamic Neuromuscular Stabilization Training on Postural Control in Patients With Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Purpose of the study This study will be conducted to investigate any significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension.
Detailed Description
PURPOSE: This study will be conducted to investigate any significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension. BACKGROUND: The most recent global estimates suggested that hypertension (HTN) affected 1.13 billion people worldwide. Raised blood pressure (BP) has emerged as the most important risk factor for global morbidity and mortality. Hypertensive individuals present slower processing speed, reduced static and dynamic balance, decreased functional mobility during both single and dual tasking and higher fear of falling in comparison to normotensive individuals. These findings expand the body of knowledge about the effects of HTN on physical functions like prolonged processing time, disturbed balance and reduced mobility functions, which may guide clinicians in including preventive and rehabilitative strategies to their therapy protocols in order to improve the quality of life of the individuals with HTN. HYPOTHESES: Null Hypothesis: there will be no significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension. RESEARCH QUESTION: Will be any significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel study is a type of clinical study in which two or more groups of participants receive different interventions.
Masking
ParticipantOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D. N.S
Arm Type
Experimental
Arm Description
dynamic neuromuscular stabilization training methods demonstrated efficacy in improving global trunk stabilizing patterns with noted gains in extremity movement and strength
Arm Title
balance exercises plus diaphragmatic breathing
Arm Type
Experimental
Arm Description
balance exercises plus diaphragmatic breathing The balance exercises is balance training while standing and walking and The patient assume a semi-Fowler's position and perform diaphragmatic breathing.
Intervention Type
Other
Intervention Name(s)
dynamic neuromuscular stabilization training
Intervention Description
DNS methods demonstrated efficacy in improving global trunk stabilizing patterns with noted gains in extremity movement and strength
Intervention Type
Other
Intervention Name(s)
balance exercises plus diaphragmatic breathing
Intervention Description
The balance exercises is balance exercises while standing and walking The patient assume a semi-Fowler's position and perform diaphragmatic breathing.
Primary Outcome Measure Information:
Title
Postural control by Biodex Balance System
Description
The overall stability index (OSI), anteroposterior stability index (APSI), and mediolateral stability index (MLSI) are recorded with a Biodex Balance System, Postural stability test will be performed in the double leg standing position with the eyes open and closed and in the single leg standing position with the eyes open and closed on the right and left legs
Time Frame
8 weeks
Title
balance by The Modified star excursion balance test (mSEBT)
Description
• Patients will perform testing while barefoot, maintaining their hands on their hips and a series of single-limb squats using the non-stance limb to touch a point a maximum distance along designated lines on the ground
Time Frame
8 weeks
Title
dynamic balance and functional mobility by Timed-Up-and-Go test (TUG)
Description
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down while turning
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Sleep quality: using The Pittsburgh Sleep Quality Index (PSQI)
Description
It is used to determine self-reported sleep quality and sleep disturbances for the preceding month. It is a 19-item test and consists of seven components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) sleep efficiency, (5) sleep disturbance, (6) sleeping medication use and (7) daytime dysfunction.
Time Frame
8 weeks
Title
Quality of life: using The 12 Item Short Form Health Survey (SF-12) Questionnaire
Description
• The SF-12 consists of 12 questions that examine eight different health domains in order to determine physical and mental health. General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP) are the physical health domains. Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH) are mental health-related scales
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sixty men patients with stage two essential HTN (more than 140/90 mm hg). Their age will be ranged from 50-60 years old. Body mass index (BMI) from 25 to 34.9 kg/m2. Low levels of physical activity (using the International Physical Activity Questionnaire-Short Version) (The Arabic version of the questionnaire will be used) Exclusion Criteria: Uncontrolled HTN. Diabetes mellitus. Heavy Smoker. Neurological or musculoskeletal conditions that interfere with gait Vertebrobasilar insufficiency (VBI). Use of psychotropic drugs. Impaired vision and/or hearing. Unstable medical conditions. Patients who are unable to follow verbal instructions. Participation in regular exercise training of any type in the previous 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shimaa Taha Mohamed Taha, ASS.LEC
Phone
01021088610
Email
Shimaa.taha395@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shymaa Mohamed Ali, lecturer
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesreen
Phone
+201002227242
Email
nesreen.elnahas@pt.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Amel
Phone
37617693
Email
dean@pt.cu.edu.eg
Facility Name
Faculty of physical therapy
City
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

Citations:
PubMed Identifier
31570266
Citation
Ozaldemir I, Iyigun G, Malkoc M. Comparison of processing speed, balance, mobility and fear of falling between hypertensive and normotensive individuals. Braz J Phys Ther. 2020 Nov-Dec;24(6):503-511. doi: 10.1016/j.bjpt.2019.09.002. Epub 2019 Sep 23.
Results Reference
background
PubMed Identifier
34555964
Citation
Ghavipanje V, Rahimi NM, Akhlaghi F. Six Weeks Effects of Dynamic Neuromuscular Stabilization (DNS) Training in Obese Postpartum Women With Low Back Pain: A Randomized Controlled Trial. Biol Res Nurs. 2022 Jan;24(1):106-114. doi: 10.1177/10998004211044828. Epub 2021 Sep 23.
Results Reference
background

Learn more about this trial

Effect of DNS Exercises Training on Hypertension

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