HypertensionNCT06387927
Effect of Home-exercise Programs Versus Supervised Core Stability Exercises on Hypertensive Patient With Low Back Pain
A study testing home exercise program and the core stability exercise in people with Hypertension and Low Back Pain, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Hypertension, Low Back Pain
- What is being tested?
- home exercise program and the core stability exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2023to 20 Feb 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- hypertensive patient
- patient with chronic back pain
- The patients aged 30 to 50 years
Who cannot join
- Patients with vertebral fractures
- patient with surgical spinal fixation
- patient with rheumatic disorders
- patient with systemic diseases
- patient with multiple sclerosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Home-based Exercise Programs Versus Supervised Conventional Core Stability Exercises in Treatment of Chronic Mechanical, Non-specific Low Back Pain Patients With Controlled Hypertension
Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain.
- Conditions
- Hypertension, Low Back Pain
- Being tested
- home exercise program, the core stability exercise
- Medical subject headings
- Hypertension, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home exercise programOther
Patients in group B were taught the core stability exercise in the first visit they received Arabic printed booklet for exercise description repetitions with diagrams in addition to Arabic illustration videos, they received a weekly telephone call to ensure their compliance to the exercise \& motivation.
the core stability exerciseOther
supervised conventional core stability exercise
| Study group | Role | What they receive |
|---|---|---|
| Group A (control) received supervised conventional core stability exercise program Study | Active comparator | Group A (control) received supervised conventional core stability exercise program Receives: Other: the core stability exercise |
| group B received a home-based exercise program | Experimental | Group B received a home-based exercise program. Receives: Other: home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
Pain was assessed using the visual analog scale
Measured: up to 4 weeks
Assessment of lumbar flexion range of motion
performed by modified modified schober test
Measured: up to 4 weeks
Assessment of functional disability
performed by Oswestry disability questionnaire version 2.0
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start2 Sep 2023
- Primary completion2 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ababa, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387927
- Sponsor's protocol ID
- PT-NEUR-10/2023-520
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Home-based Exercise Programs Versus Supervised Conventional Core Stability Exercises in Treatment of Chronic Mechanical, Non-specific Low Back Pain Patients With Controlled Hypertension
- ClinicalTrials.gov ID
- NCT06387927
- Acronym / sponsor ID
- PT-NEUR-10/2023-520
- Conditions
- Hypertension, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 29 Apr 2024 (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.
Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (control) received supervised conventional core stability exercise program Study | Active comparator | Other: the core stability exerciseGroup A (control) received supervised conventional core stability exercise program |
| group B received a home-based exercise program | Experimental | Other: home exercise programGroup B received a home-based exercise program. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- hypertensive patient
- patient with chronic back pain
- The patients aged 30 to 50 years
Key exclusion criteria (5 listed)
- Patients with vertebral fractures
- patient with surgical spinal fixation
- patient with rheumatic disorders
- patient with systemic diseases
- patient with multiple sclerosis.
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 |
|---|---|---|
| home exercise programPatients in group B were taught the core stability exercise in the first visit they received Arabic printed booklet for exercise description repetitions with diagrams in addition to Arabic illustration videos, they received a weekly telephone call to ensure their compliance to the exercise \& motivation. | Other | group B received a home-based exercise program |
| the core stability exercisesupervised conventional core stability exercise | Other | Group A (control) received supervised conventional core stability exercise program Study |
Primary outcome
Assessment of pain
Time frame: up to 4 weeks
Pain was assessed using the visual analog scale
Assessment of lumbar flexion range of motion
Time frame: up to 4 weeks
performed by modified modified schober test
Assessment of functional disability
Time frame: up to 4 weeks
performed by Oswestry disability questionnaire version 2.0
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 29 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home exercise program and the core stability exercise in people with Hypertension and Low Back Pain, run by Ahram Canadian 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 3 inclusion and 5 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 29 Apr 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?
Assessment of pain (time frame: up to 4 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?
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 29 Apr 2024.