NCT05900713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

June 4, 2023

Last Update Submit

August 18, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 and in the single leg standing position on the right and left legs

    8 weeks

  • 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

    8 weeks

  • 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

    8 weeks

Secondary Outcomes (2)

  • Sleep quality: using The Pittsburgh Sleep Quality Index (PSQI)

    8 weeks

  • Quality of life: using The 12 Item Short Form Health Survey (SF-12) Questionnaire

    8 weeks

Study Arms (2)

D. N.S

EXPERIMENTAL

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

Other: dynamic neuromuscular stabilization training

balance exercises plus diaphragmatic breathing

EXPERIMENTAL

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.

Other: balance exercises plus diaphragmatic breathing

Interventions

DNS methods demonstrated efficacy in improving global trunk stabilizing patterns with noted gains in extremity movement and strength

D. N.S

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

balance exercises plus diaphragmatic breathing

Eligibility Criteria

Age50 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 12613, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 31570266BACKGROUND
  • 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.

    PMID: 34555964BACKGROUND

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Shymaa Mohamed Ali, lecturer

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel study is a type of clinical study in which two or more groups of participants receive different interventions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 4, 2023

First Posted

June 12, 2023

Study Start

July 1, 2023

Primary Completion

January 1, 2024

Study Completion

May 30, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations