PrehypertensionPRANvsJPMRNCT06656130
Pranayama and Jacobson's Progressive Muscle Relaxation Technique in Pre-hypertensive Patients
A study testing Pranayama and Jacobson's progressive muscle relaxation technique in people with Prehypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
Objective of our study is to determine the comparative effects of Pranayama and Jacobson's Relaxation Technique on cardiovascular parameters, stress and quality of life in Pre-hypertensive patients. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Prehypertension
- What is being tested?
- Pranayama and Jacobson's progressive muscle relaxation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2024to Jan 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: Participants must be between 30 and 60 years old.
- Gender: Male and Female both.
- Diagnosed patients of Pre-hypertension.
- Stable health condition to participate in moderate physical activities.
- Willing to comply with the study protocol, including attending scheduled exercise sessions and follow-up assessments
Who cannot join
- Diagnosed case of Hypertension or takes any antihypertensive medication.
- Patient having any other associated systemic disorder are excluded.
- Severe physical limitations, disabilities, or musculoskeletal disorders.
- History of substance abuse.
- Patients with Neurological diseases
- Patients with severe or unstable heart conditions, recent heart attack, or heart failure, other cardiovascular disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sialkot Medical and Physiotherapy Center
Sialkot, Punjab Province, 51310
About this study
Official title: Comparative Effects of Pranayama and Jacobson;s Progressive Muscle Relaxation Technique on Cardiovascular Parameters,Stress and Quality of Life in Pre-hypertension
Objective of our study is to determine the comparative effects of Pranayama and Jacobson's Relaxation Technique on cardiovascular parameters, stress and quality of life in Pre-hypertensive patients.
This study is used to determine the effects of Pranayama versus Jacobson's Progressive Muscle Relaxation Technique on cardiorespiratory parameters, stress and quality of life in pre-hypertensive patients.
Read more
This randomized clinical trial (RCT) endeavors to enroll ___ participants, divided equally into Pranayama and Jacobson's Progressive Muscle Relaxation Technique groups. The non-probability convenient sampling technique, followed by random allocation using a lottery method, ensures a diverse yet unbiased sample. Study is being conducted at the Kashmir Medical Complex Sialkot.
The Pranayama group(n=25) undergoes sessions three times a week, emphasizing breathing techniques like alternate nostril technique and bellow breathing.
The Jacobson's Progressive Muscle Relaxation Technique group(n=25) follows a similar schedule, engaging in full-body relaxation exercises targeting major muscle groups. Parameters will be assessed on 1st day, 3rd week and 8th week by outcome measures, SPSS version 23 will be used for analysis.
Read the detailed description
This is a randomized controlled trial used to determine the effects of Pranayama and Jacobson's progressive muscle relaxation technique on Cardiovascular parameters, Stress and Quality of Life in Prehypertensive Patients.
A Nonprobability Convenient Sampling Technique will be used and random allocation into groups using the Lottery method. Patients will be assigned into 2 groups i.e. Group A \& Group B Group A: will receive Pranayama. Pranayama is the practice of breath regulation. It's a main component of yoga, an exercise for physical and mental wellness. The practice of pranayama involves breathing exercises and patterns. Patient will purposely inhale, exhale, and hold his/her breath in a specific sequence. Interventions will be performed for 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24). Breathing exercises will be consist on Alternate Nostril Technique, Skull Shinning Technique, Bellow Breath, Bee Breath, Victorious Breath Group B: will receive Jacobson's Progressive Muscle Relaxation Technique. Jacobson's relaxation technique is a type of therapy that will focus on tightening and relaxing specific 14 muscle groups in sequence. It's also known as progressive relaxation therapy. By concentrating on specific areas and tensing and then relaxing them, Patient can become more aware of his/her body and physical sensations, The sessions will consist of 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24).
Prior to the study, all participants will be informed of the purpose and method of conducting the research. Each of them will sign an informed consent to participate in the study and to process personal data for scientific purposes. We confirm that all research will be performed in accordance with relevant guidelines and regulations.
Participants will be divided into 2 experimental groups. Group 1 will perform Pranayama and Group 2 will perform Jacobson's progressive muscle relaxation technique.
Both the interventions will be performed for 30 minutes in a day, 3 days per week for 8 weeks.
SPSS for Windows software, version 25 will be used to analyze the data using statistical significance p=0.05. After assessing the normality, if the p-value is greater than 0.05, a parametric test will be applied. If the p-value is less than 0.05 then a nonparametric test will be applied.
Descriptive Statistics: Frequency tables, pie charts, and bar charts will be used for categorical data to show a summary of group measurements measured over time.
Difference between groups: Anova Test will be used.
- Conditions
- Prehypertension
- Being tested
- Pranayama, Jacobson's progressive muscle relaxation technique
- Keywords
- : Jacobson's Progressive Muscle Relaxation Technique, Pranayama, Pre-hypertension
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PranayamaOther
Also called Breathing Technique
Pranayama is the practice of breath regulation. It's a main component of yoga, an exercise for physical and mental wellness. The practice of pranayama involves breathing exercises and patterns. Patient purposely inhale, exhale, and hold his/her breath in a specific sequence.
Jacobson's progressive muscle relaxation techniqueOther
Also called Breathing and stretching technique
Jacobson's relaxation technique is a type of therapy that focuses on tightening and relaxing specific 14 muscle groups in sequence. It's also known as progressive relaxation therapy. By concentrating on specific areas and tensing and then relaxing them, patient can become more aware of his/her body and physical sensations,
| Study group | Role | What they receive |
|---|---|---|
| Effects of Pranayama on cardiovascular parameters, stress and quality of life in pre-hypertension | Experimental | This group will receive Pranayama. Pranayama is the practice of breath regulation. It's a main component of yoga, an exercise for physical and mental wellness. The practice of pranayama involves breathing exercises and patterns. You purposely inhale, exhale, and hold your breath in a specific sequence. Interventions will be performed for 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24). Breathing exercises will be consist on Alternate Nostril Technique, Skull Shinning Technique, Bellow Breath, Bee Breath, Victorious Breath Receives: Other: Pranayama |
| effects of Jacobson's technique on CVS parameters, stress and QOL in Pre-hypertension | Experimental | This group will receive Jacobson's Progressive Muscle Relaxation Technique. Jacobson's relaxation technique is a type of therapy that focuses on tightening and relaxing specific 14 muscle groups in sequence. It's also known as progressive relaxation therapy. By concentrating on specific areas and tensing and then relaxing them, you can become more aware of your body and physical sensations, The sessions will consist of 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24). Receives: Other: Jacobson's progressive muscle relaxation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSR (Perceived Stress Scale)
The Perceived Stress Scale (PSS) is one of the most widely used instruments to measure stress perceptions. The original PSS is a 14-item self-report measure designed to assess "the degree to which situations in one's life are appraised as stressful". It is a global measure of stress, rather than a measure of specific stressful life events. Specifically, items assess the extent to which one's life is perceived as "unpredictable, uncontrollable, and overloading
Measured: 8 weeks
SF-12 (QOL)
Quality of life (QOL) is a broad multidimensional concept that usually includes subjective evaluations of both positive and negative aspects of life. The SF-12 Health Survey version 2 (SF-12v2) is a generic short-form health survey developed in the USA from the original SF36. It produces two summary measures evaluating physical and mental self-perceived health; for this reason, it could be a suitable and complete tool to assess the self-perceived quality of life of university students because it allows investigating both the aspects
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 posted24 Oct 2024
- Study start15 Apr 2024
- Primary completion15 Dec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumera AbdulHameed Supervisor/ Research Incharge, M.PHIL, Principal investigator, Riphah International University Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656130
- Sponsor's protocol ID
- Huma52160
- Acronym
- PRANvsJPMR
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Pranayama and Jacobson;s Progressive Muscle Relaxation Technique on Cardiovascular Parameters,Stress and Quality of Life in Pre-hypertension
- ClinicalTrials.gov ID
- NCT06656130
- Acronym / sponsor ID
- PRANvsJPMR / Huma52160
- Conditions
- Prehypertension
- Keywords
- : Jacobson's Progressive Muscle Relaxation Technique, Pranayama, Pre-hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 24 Oct 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.
Objective of our study is to determine the comparative effects of Pranayama and Jacobson's Relaxation Technique on cardiovascular parameters, stress and quality of life in Pre-hypertensive patients.
This study is used to determine the effects of Pranayama versus Jacobson's Progressive Muscle Relaxation Technique on cardiorespiratory parameters, stress and quality of life in pre-hypertensive patients.
This randomized clinical trial (RCT) endeavors to enroll ___ participants, divided equally into Pranayama and Jacobson's Progressive Muscle Relaxation Technique groups. The non-probability convenient sampling technique, followed by random allocation using a lottery method, ensures a diverse yet unbiased sample. Study is being conducted at the Kashmir Medical Complex Sialkot.
The Pranayama group(n=25) undergoes sessions three times a week, emphasizing breathing techniques like alternate nostril technique and bellow breathing.
The Jacobson's Progressive Muscle Relaxation Technique group(n=25) follows a similar schedule, engaging in full-body relaxation exercises targeting major muscle groups. Parameters will be assessed on 1st day, 3rd week and 8th week by outcome measures, SPSS version 23 will be used for analysis.
Detailed description
This is a randomized controlled trial used to determine the effects of Pranayama and Jacobson's progressive muscle relaxation technique on Cardiovascular parameters, Stress and Quality of Life in Prehypertensive Patients.
A Nonprobability Convenient Sampling Technique will be used and random allocation into groups using the Lottery method. Patients will be assigned into 2 groups i.e. Group A \& Group B Group A: will receive Pranayama. Pranayama is the practice of breath regulation. It's a main component of yoga, an exercise for physical and mental wellness. The practice of pranayama involves breathing exercises and patterns. Patient will purposely inhale, exhale, and hold his/her breath in a specific sequence. Interventions will be performed for 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24). Breathing exercises will be consist on Alternate Nostril Technique, Skull Shinning Technique, Bellow Breath, Bee Breath, Victorious Breath Group B: will receive Jacobson's Progressive Muscle Relaxation Technique. Jacobson's relaxation technique is a type of therapy that will focus on tightening and relaxing specific 14 muscle groups in sequence. It's also known as progressive relaxation therapy. By concentrating on specific areas and tensing and then relaxing them, Patient can become more aware of his/her body and physical sensations, The sessions will consist of 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24).
Prior to the study, all participants will be informed of the purpose and method of conducting the research. Each of them will sign an informed consent to participate in the study and to process personal data for scientific purposes. We confirm that all research will be performed in accordance with relevant guidelines and regulations.
Participants will be divided into 2 experimental groups. Group 1 will perform Pranayama and Group 2 will perform Jacobson's progressive muscle relaxation technique.
Both the interventions will be performed for 30 minutes in a day, 3 days per week for 8 weeks.
SPSS for Windows software, version 25 will be used to analyze the data using statistical significance p=0.05. After assessing the normality, if the p-value is greater than 0.05, a parametric test will be applied. If the p-value is less than 0.05 then a nonparametric test will be applied.
Descriptive Statistics: Frequency tables, pie charts, and bar charts will be used for categorical data to show a summary of group measurements measured over time.
Difference between groups: Anova Test will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effects of Pranayama on cardiovascular parameters, stress and quality of life in pre-hypertension | Experimental | Other: PranayamaThis group will receive Pranayama. Pranayama is the practice of breath regulation. It's a main component of yoga, an exercise for physical and mental wellness. The practice of pranayama involves breathing exercises and patterns. You purposely inhale, exhale, and hold your breath in a specific sequence. Interventions will be performed for 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24). Breathing exercises will be consist on Alternate Nostril Technique, Skull Shinning Technique, Bellow Breath, Bee Breath, Victorious Breath |
| effects of Jacobson's technique on CVS parameters, stress and QOL in Pre-hypertension | Experimental | Other: Jacobson's progressive muscle relaxation techniqueThis group will receive Jacobson's Progressive Muscle Relaxation Technique. Jacobson's relaxation technique is a type of therapy that focuses on tightening and relaxing specific 14 muscle groups in sequence. It's also known as progressive relaxation therapy. By concentrating on specific areas and tensing and then relaxing them, you can become more aware of your body and physical sensations, The sessions will consist of 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: Participants must be between 30 and 60 years old.
- Gender: Male and Female both.
- Diagnosed patients of Pre-hypertension.
- Stable health condition to participate in moderate physical activities.
- Willing to comply with the study protocol, including attending scheduled exercise sessions and follow-up assessments
Key exclusion criteria (6 listed)
- Diagnosed case of Hypertension or takes any antihypertensive medication.
- Patient having any other associated systemic disorder are excluded.
- Severe physical limitations, disabilities, or musculoskeletal disorders.
- History of substance abuse.
- Patients with Neurological diseases
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 |
|---|---|---|
| PranayamaAlso: Breathing TechniquePranayama is the practice of breath regulation. It's a main component of yoga, an exercise for physical and mental wellness. The practice of pranayama involves breathing exercises and patterns. Patient purposely inhale, exhale, and hold his/her breath in a specific sequence. | Other | Effects of Pranayama on cardiovascular parameters, stress and quality of life in pre-hypertension |
| Jacobson's progressive muscle relaxation techniqueAlso: Breathing and stretching techniqueJacobson's relaxation technique is a type of therapy that focuses on tightening and relaxing specific 14 muscle groups in sequence. It's also known as progressive relaxation therapy. By concentrating on specific areas and tensing and then relaxing them, patient can become more aware of his/her body and physical sensations, | Other | effects of Jacobson's technique on CVS parameters, stress and QOL in Pre-hypertension |
Primary outcome
PSR (Perceived Stress Scale)
Time frame: 8 weeks
The Perceived Stress Scale (PSS) is one of the most widely used instruments to measure stress perceptions. The original PSS is a 14-item self-report measure designed to assess "the degree to which situations in one's life are appraised as stressful". It is a global measure of stress, rather than a measure of specific stressful life events. Specifically, items assess the extent to which one's life is perceived as "unpredictable, uncontrollable, and overloading
SF-12 (QOL)
Time frame: 8 weeks
Quality of life (QOL) is a broad multidimensional concept that usually includes subjective evaluations of both positive and negative aspects of life. The SF-12 Health Survey version 2 (SF-12v2) is a generic short-form health survey developed in the USA from the original SF36. It produces two summary measures evaluating physical and mental self-perceived health; for this reason, it could be a suitable and complete tool to assess the self-perceived quality of life of university students because it allows investigating both the aspects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 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.
Sumera AbdulHameed Supervisor/ Research Incharge, M.PHIL principal investigator
Riphah International University Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama and Jacobson's progressive muscle relaxation technique in people with Prehypertension, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Oct 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 Pakistan. 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?
Results are not available in the source record.
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?
PSR (Perceived Stress Scale) (time frame: 8 weeks). The study lists 2 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 24 Oct 2024.