HypertensionNCT06315764
Effect of the Reflexology on Insomnia Severity Index in Hypertensive Patients
A study testing Reflexology in people with Hypertension, run by Cairo University at 1 site in Egypt.
Trial summary
In Egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Reflexology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 May 2023
- 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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Forty hypertensive patients aged 35 to 45 years of both sexes (men and women).
- Clinical and medically, all of the participants were in good health.
- The BMI ranged from 30 to 34.9 kg/m2 for all participants.
Who cannot join
- Close Myocardial infarcts.
- Heart block or complex ventricular arrhythmia
- Cerebrovascular disease is a condition in which the blood vessels in the brain become inflamed.
- Defects in vision or hearing.
- Significant tightness in the lower limbs and/or a fixed deformity of lower limbs.
- Balance or mentality-related neurological diseases (e.g. epilepsy).
- Abnormalities of lower limb that may be congenital or acquired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Reflexology Versus Aerobic Training on Insomnia Severity Index and Quality of Life in Hypertensive Patients
In Egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life.
Read the detailed description
The participated subjects were enrolled based on the inclusion and exclusion criteria , In this study, forty hypertensive female patients between 35 and 45 were divided to two equal groups (A and B). Twenty female patients in group (A) got medications and peddling training, while twenty female patients in group (B) had the exact treatment as group (A) as well as reflexology. Insomina severity index and a short form 36 quality of life questionnaire were used to assess the patients who took part in the study (ISI). They were assessed before and after the eight-week treatment program, which consisted of three sessions each week; following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).
- Conditions
- Hypertension
- Being tested
- Reflexology
- Keywords
- Reflexology, Insomina Severity Index; Hypertensive patients.
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyProcedure or surgery
Also called Aerobic training
Following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).Before and after the foot reflexology, blood pressure was checked twice. Around 20 minutes is spent on foot reflexology .
Each patient in this study did 20 minutes of peddler aerobic training, with the first 5 minutes serving as a warm-up with intensity set at 60 - 65 percent of maximal heart rate, followed by another 10 minutes of peddler training with intensity gradually increased up to 70 - 75 percent, and the last 5 minutes serving as a cooling down with intensity set at 60 - 65 percent of maximal heart rate. After the warm-up and at the end of each training phase, the participants' heart rates were monitored. Finally, if the individual experienced pain, fainting, or shortness of breath, the training was promptly terminated as well as reflexology three times each week for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training | Experimental | Each patient in this study did 20 minutes of peddler aerobic training, with the first 5 minutes serving as a warm-up with intensity set at 60 - 65 percent of maximal heart rate, followed by another 10 minutes of peddler training with intensity gradually increased up to 70 - 75 percent, and the last 5 minutes serving as a cooling down with intensity set at 60 - 65 percent of maximal heart rate. After the warm-up and at the end of each training phase, the participants' heart rates were monitored. Finally, if the individual experienced pain, fainting, or shortness of breath, the training was promptly terminated Receives: Procedure: Reflexology |
| Reflexology | Experimental | This group consisted of twenty female patients suffering from hypertension who received the same drugs as group (A) as well as reflexology three times per week for eight weeks .
Following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).Before and after the foot reflexology, blood pressure was checked twice. Around 20 minutes is spent on foot reflexology . Receives: Procedure: Reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity index
The Insomnia severity index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem),
Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) The higher score is the worse outcome.
Measured: four weeks then four weeks( eight weeks)
Short form 36 quality of life questionnaire (SF-36):
it is used for measuring health-related quality of life (HRQL) which consists of 36 questions (SF-36) (limitations on physical functioning because of health problems), it was done personal interviewing using Arabic version
Measured: four weeks then four weeks( eight weeks)
Blood pressure measurements:
it consisted of systolic blood pressure which measures the pressure in arteries when heart beats and diastolic blood pressure which measures the pressure in arteries when heart rests between beats.
Measured: four weeks then four weeks( eight weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jan 2022
- Primary completion30 Jan 2022
- Study completion30 May 2023
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 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
- Group (A): It consists of twenty female patients suffering from hypertension who underwent medical treatment as well as peddler training three times per week for eight weeks. After four weeks of treatment (post-1) and another four weeks of treatment, the post evaluation was used (post-2). Group (B): This group consisted of twenty female patients suffering from hypertension who received the same drugs as group (A) as well as reflexology three times per week for eight weeks
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Mousa Galeb, Cairo University
- Investigators
- heba mousa, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315764
- Sponsor's protocol ID
- Hypertensive patients
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boutcher YN, Boutcher SH. Exercise intensity and hypertension: what's new? J Hum Hypertens. 2017 Mar;31(3):157-164. doi: 10.1038/jhh.2016.62. Epub 2016 Sep 8.
PubMed 27604656Gudsoorkar PS, Tobe SW. Changing concepts in hypertension management. J Hum Hypertens. 2017 Dec;31(12):763-767. doi: 10.1038/jhh.2017.57. Epub 2017 Jul 27.
PubMed 28748919
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Reflexology Versus Aerobic Training on Insomnia Severity Index and Quality of Life in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT06315764
- Acronym / sponsor ID
- Hypertensive patients
- Conditions
- Hypertension
- Keywords
- Reflexology, Insomina Severity Index; Hypertensive patients.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 18 Mar 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.
In Egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life.
Detailed description
The participated subjects were enrolled based on the inclusion and exclusion criteria , In this study, forty hypertensive female patients between 35 and 45 were divided to two equal groups (A and B). Twenty female patients in group (A) got medications and peddling training, while twenty female patients in group (B) had the exact treatment as group (A) as well as reflexology. Insomina severity index and a short form 36 quality of life questionnaire were used to assess the patients who took part in the study (ISI). They were assessed before and after the eight-week treatment program, which consisted of three sessions each week; following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group (A): It consists of twenty female patients suffering from hypertension who underwent medical treatment as well as peddler training three times per week for eight weeks. After four weeks of treatment (post-1) and another four weeks of treatment, the post evaluation was used (post-2). Group (B): This group consisted of twenty female patients suffering from hypertension who received the same drugs as group (A) as well as reflexology three times per week for eight weeks
| Arm | Type | Receives |
|---|---|---|
| Aerobic training | Experimental | Procedure: ReflexologyEach patient in this study did 20 minutes of peddler aerobic training, with the first 5 minutes serving as a warm-up with intensity set at 60 - 65 percent of maximal heart rate, followed by another 10 minutes of peddler training with intensity gradually increased up to 70 - 75 percent, and the last 5 minutes serving as a cooling down with intensity set at 60 - 65 percent of maximal heart rate. After the warm-up and at the end of each training phase, the participants' heart rates were monitored. Finally, if the individual experienced pain, fainting, or shortness of breath, the training was promptly terminated |
| Reflexology | Experimental | Procedure: ReflexologyThis group consisted of twenty female patients suffering from hypertension who received the same drugs as group (A) as well as reflexology three times per week for eight weeks . Following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).Before and after the foot reflexology, blood pressure was checked twice. Around 20 minutes is spent on foot reflexology . |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Forty hypertensive patients aged 35 to 45 years of both sexes (men and women).
- Clinical and medically, all of the participants were in good health.
- The BMI ranged from 30 to 34.9 kg/m2 for all participants.
Key exclusion criteria (7 listed)
- Close Myocardial infarcts.
- Heart block or complex ventricular arrhythmia
- Cerebrovascular disease is a condition in which the blood vessels in the brain become inflamed.
- Defects in vision or hearing.
- Significant tightness in the lower limbs and/or a fixed deformity of lower limbs.
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 |
|---|---|---|
| ReflexologyAlso: Aerobic trainingFollowing four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).Before and after the foot reflexology, blood pressure was checked twice. Around 20 minutes is spent on foot reflexology . Each patient in this study did 20 minutes of peddler aerobic training, with the first 5 minutes serving as a warm-up with intensity set at 60 - 65 percent of maximal heart rate, followed by another 10 minutes of peddler training with intensity gradually increased up to 70 - 75 percent, and the last 5 minutes serving as a cooling down with intensity set at 60 - 65 percent of maximal heart rate. After the warm-up and at the end of each training phase, the participants' heart rates were monitored. Finally, if the individual experienced pain, fainting, or shortness of breath, the training was promptly terminated as well as reflexology three times each week for eight weeks | Procedure or surgery | Aerobic training, Reflexology |
Primary outcome
Insomnia severity index
Time frame: four weeks then four weeks( eight weeks)
The Insomnia severity index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) The higher score is the worse outcome.
Short form 36 quality of life questionnaire (SF-36):
Time frame: four weeks then four weeks( eight weeks)
it is used for measuring health-related quality of life (HRQL) which consists of 36 questions (SF-36) (limitations on physical functioning because of health problems), it was done personal interviewing using Arabic version
Blood pressure measurements:
Time frame: four weeks then four weeks( eight weeks)
it consisted of systolic blood pressure which measures the pressure in arteries when heart beats and diastolic blood pressure which measures the pressure in arteries when heart rests between beats.
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 18 Mar 2024.
- Background: PubMed 27604656Boutcher YN, Boutcher SH. Exercise intensity and hypertension: what's new? J Hum Hypertens. 2017 Mar;31(3):157-164. doi: 10.1038/jhh.2016.62. Epub 2016 Sep 8.
- Background: PubMed 28748919Gudsoorkar PS, Tobe SW. Changing concepts in hypertension management. J Hum Hypertens. 2017 Dec;31(12):763-767. doi: 10.1038/jhh.2017.57. Epub 2017 Jul 27.
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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.
heba mousa principal investigator
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 Reflexology in people with 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 3 inclusion and 7 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 18 Mar 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?
Insomnia severity index (time frame: four weeks then four weeks( eight 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 NCT06315764, 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 18 Mar 2024.