Essential HypertensionNCT05900713
Effect of DNS Exercises Training on Hypertension
A study testing dynamic neuromuscular stabilization training and balance exercises plus diaphragmatic breathing in people with Essential Hypertension, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- dynamic neuromuscular stabilization training and balance exercises plus diaphragmatic breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Uncontrolled HTN.
- Diabetes mellitus.
- Heavy Smoker.
- Neurological or musculoskeletal conditions that interfere with gait
- Vertebrobasilar insufficiency (VBI).
- Use of psychotropic drugs.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dynamic Neuromuscular Stabilization Training on Postural Control in Patients With Essential Hypertension
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.
Read the 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?
- Conditions
- Essential Hypertension
- Being tested
- dynamic neuromuscular stabilization training, balance exercises plus diaphragmatic breathing
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic neuromuscular stabilization trainingOther
DNS methods demonstrated efficacy in improving global trunk stabilizing patterns with noted gains in extremity movement and strength
balance exercises plus diaphragmatic breathingOther
The balance exercises is balance exercises while standing and walking The patient assume a semi-Fowler's position and perform diaphragmatic breathing.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: balance exercises plus diaphragmatic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Jan 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel study is a type of clinical study in which two or more groups of participants receive different interventions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Taha Mohamed Taha, Cairo University
- Investigators
- Shymaa Mohamed Ali, lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900713
- Sponsor's protocol ID
- exercises on hypertension
- Status last verified
- Aug 2024
- First submitted
- 4 Jun 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31570266Ghavipanje 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.
PubMed 34555964
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dynamic Neuromuscular Stabilization Training on Postural Control in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT05900713
- Acronym / sponsor ID
- exercises on hypertension
- Conditions
- Essential Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel study is a type of clinical study in which two or more groups of participants receive different interventions.
| Arm | Type | Receives |
|---|---|---|
| D. N.S | Experimental | Other: dynamic neuromuscular stabilization trainingdynamic 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 | Experimental | Other: balance exercises plus diaphragmatic breathingbalance 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. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- Uncontrolled HTN.
- Diabetes mellitus.
- Heavy Smoker.
- Neurological or musculoskeletal conditions that interfere with gait
- Vertebrobasilar insufficiency (VBI).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic neuromuscular stabilization trainingDNS methods demonstrated efficacy in improving global trunk stabilizing patterns with noted gains in extremity movement and strength | Other | D. N.S |
| balance exercises plus diaphragmatic breathingThe balance exercises is balance exercises while standing and walking The patient assume a semi-Fowler's position and perform diaphragmatic breathing. | Other | balance exercises plus diaphragmatic breathing |
Primary outcome
Postural control by Biodex Balance System
Time frame: 8 weeks
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
balance by The Modified star excursion balance test (mSEBT)
Time frame: 8 weeks
• 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)
Time frame: 8 weeks
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
2 secondary outcomes
Sleep quality: using The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks
Quality of life: using The 12 Item Short Form Health Survey (SF-12) Questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 31570266Ozaldemir 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.
- Background: PubMed 34555964Ghavipanje 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shymaa Mohamed Ali, lecturer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic neuromuscular stabilization training and balance exercises plus diaphragmatic breathing in people with Essential Hypertension, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural control by Biodex Balance System (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05900713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.