HypertensionNCT05650138
Effects of Jacobson's Progressive Muscular Relaxation Technique in Hypertensive Patients
A study testing Jacobson's progressive muscular relaxation technique and 30 min walk in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
Effects of Jacobson's progressive muscular relaxation technique on blood pressure regulation and activity of daily living in hypertensive patient Read more about this study
- Who is it for?
- Ages 33 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Jacobson's progressive muscular relaxation technique and 30 min walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2022to 30 Nov 2022
- 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 33 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 35 to 55 years
- Ambulatory male and female
- Mentally fitted
- Diagnosed with grade 2 and grade 3 hypertension(3)
Who cannot join
- Subjects who are not regular in taking medications and who reported about aggravation of any symptoms due to exercise.(7)
- Subjects who fall in grade1 hypertension
- Subjects below the age of 30.
- History of cardiac, renal and liver diseases
- History of recent fracture or surgery.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Life Care Hospital
Chak One Hundred Seventy-five Nine Left, Punjab Province, 50250
About this study
Official title: Effects of Jacobson's Progressive Muscular Relaxation Technique on Blood Pressure Regulation and Activity of Daily Living in Hypertensive Patients
Effects of Jacobson's progressive muscular relaxation technique on blood pressure regulation and activity of daily living in hypertensive patient
Read the detailed description
Hypertension is a disease that becomes a major problem of health. In 2008, 40% of adults aged 25 years above were diagnosed with hypertension. The mortality rate of the complications of hypertension reaches 9.4 million deaths worldwide each year. Hypertension is often called a ''silent killer'' because it often appears without symptoms until it becomes severe and impacts on other organs. Hypertension affects both on physical and psychological. Several studies have found that hypertension can cause anxiety. Hypertension requires comprehensive pharmacological and non-pharmacological treatment. Since 1983, the World Health Organization has suggested the use of the non-pharmacological approach in hypertension treatment. Progressive Muscle Relaxation (PMR) is one of the therapies that is mostly used in complementary therapy and alternative medication. PMR is a technique developed by Edmund Jacobson in 1920. This technique is designed to create a state of physiological and psychological relaxation in patients. It requires the patient to tense and relax various muscle groups while focusing awareness on proprioceptive and interceptive sensations. Several studies have found that PMR exercise helps to reduce blood pressure. Besides, PMR exercise can also reduce anxiety in various diseases.
Study design will be randomized controlled trial. Study will be conducted at Life care Hospital Gujranwala. Written informed consent will be obtained. Patients will be allocated randomly. Subjects meeting the predetermined inclusion and exclusion criteria . Questionnaire will be used as subjective measurements of activity of daily living and Bp will be monitored for initial readings.subjects will be divided into two groups both groups will perform 30 minutes walk as baseline treatment. only one group will receive Jacobsons muscle relaxation technique. Patients will be demonstrated with the technique to contract and relax various groups of muscles, to coordinate contractions and relaxations with deep breaths and to perform the entire procedure with eyes closed in supine lying down position. Every subject will perform this supervised relaxation for 6 repetitions during a single session on once a day basis for four weeks. At the end of 4 weeks of treatment session blood pressure will be recorded questionnaire will be filled. The data thus obtained will be considered for statistical analysis
- Conditions
- Hypertension
- Being tested
- Jacobson's progressive muscular relaxation technique, 30 min walk
- Keywords
- Hypertension, blood pressure, Relaxation, PMR
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jacobson's progressive muscular relaxation techniqueOther
subjects will receive Jacobsons muscle relaxation technique. Patients will be demonstrated with the technique to contract and relax various groups of muscles, to coordinate contractions and relaxations with deep breaths and to perform the entire procedure with eyes closed in supine lying down position. Every subject will perform this supervised relaxation for 6 repetitions during a single session on once a day basis for four weeks.
30 min walkOther
30 minutes walk twice a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| jacobson's progressive muscular relaxation technique | Experimental | Questionnaire will be used as subjective measurements of activity of daily living and Bp will be monitored for initial readings. They will receive Jacobsons muscle relaxation technique. Patients will be demonstrated with the technique to contract and relax various groups of muscles, to coordinate contractions and relaxations with deep breaths and to perform the entire procedure with eyes closed in supine lying down position. Every subject will perform this supervised relaxation for 6 repetitions during a single session on once a day basis twice a week for four weeks. At the end of 4 weeks of treatment session blood pressure will be recorded questionnaire will be filled Receives: Other: Jacobson's progressive muscular relaxation technique; Other: 30 min walk |
| 30 min walk | Active comparator | 4 weeks, twice a week, 30 minutes walk Receives: Other: 30 min walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in blood pressure
subjects will receive Jacobsons muscle relaxation technique. Patients will be demonstrated with the technique to contract and relax various groups of muscles, to coordinate contractions and relaxations with deep breaths and to perform the entire procedure with eyes closed in supine lying down position. Every subject will perform this supervised relaxation for 6 repetitions during a single session on once a day basis for four weeks.
Measured: twice a week for four weeks
Barthel Index for Activity of daily living
The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start2 May 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
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.
- 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
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumera Abdulhameed, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650138
- Sponsor's protocol ID
- REC/RCR&AHS/22/0338
- Status last verified
- Dec 2022
- First submitted
- 8 Nov 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Jacobson's Progressive Muscular Relaxation Technique on Blood Pressure Regulation and Activity of Daily Living in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT05650138
- Acronym / sponsor ID
- REC/RCR&AHS/22/0338
- Conditions
- Hypertension
- Keywords
- Hypertension, blood pressure, Relaxation, PMR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 14 Dec 2022 (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.
Effects of Jacobson's progressive muscular relaxation technique on blood pressure regulation and activity of daily living in hypertensive patient
Detailed description
Hypertension is a disease that becomes a major problem of health. In 2008, 40% of adults aged 25 years above were diagnosed with hypertension. The mortality rate of the complications of hypertension reaches 9.4 million deaths worldwide each year. Hypertension is often called a ''silent killer'' because it often appears without symptoms until it becomes severe and impacts on other organs. Hypertension affects both on physical and psychological. Several studies have found that hypertension can cause anxiety. Hypertension requires comprehensive pharmacological and non-pharmacological treatment. Since 1983, the World Health Organization has suggested the use of the non-pharmacological approach in hypertension treatment. Progressive Muscle Relaxation (PMR) is one of the therapies that is mostly used in complementary therapy and alternative medication. PMR is a technique developed by Edmund Jacobson in 1920. This technique is designed to create a state of physiological and psychological relaxation in patients. It requires the patient to tense and relax various muscle groups while focusing awareness on proprioceptive and interceptive sensations. Several studies have found that PMR exercise helps to reduce blood pressure. Besides, PMR exercise can also reduce anxiety in various diseases.
Study design will be randomized controlled trial. Study will be conducted at Life care Hospital Gujranwala. Written informed consent will be obtained. Patients will be allocated randomly. Subjects meeting the predetermined inclusion and exclusion criteria . Questionnaire will be used as subjective measurements of activity of daily living and Bp will be monitored for initial readings.subjects will be divided into two groups both groups will perform 30 minutes walk as baseline treatment. only one group will receive Jacobsons muscle relaxation technique. Patients will be demonstrated with the technique to contract and relax various groups of muscles, to coordinate contractions and relaxations with deep breaths and to perform the entire procedure with eyes closed in supine lying down position. Every subject will perform this supervised relaxation for 6 repetitions during a single session on once a day basis for four weeks. At the end of 4 weeks of treatment session blood pressure will be recorded questionnaire will be filled. The data thus obtained will be considered for statistical analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| jacobson's progressive muscular relaxation technique | Experimental | Other: Jacobson's progressive muscular relaxation technique, Other: 30 min walkQuestionnaire will be used as subjective measurements of activity of daily living and Bp will be monitored for initial readings. They will receive Jacobsons muscle relaxation technique. Patients will be demonstrated with the technique to contract and relax various groups of muscles, to coordinate contractions and relaxations with deep breaths and to perform the entire procedure with eyes closed in supine lying down position. Every subject will perform this supervised relaxation for 6 repetitions during a single session on once a day basis twice a week for four weeks. At the end of 4 weeks of treatment session blood pressure will be recorded questionnaire will be filled |
| 30 min walk | Active comparator | Other: 30 min walk4 weeks, twice a week, 30 minutes walk |
Who may qualify
- Ages
- 33 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 35 to 55 years
- Ambulatory male and female
- Mentally fitted
- Diagnosed with grade 2 and grade 3 hypertension(3)
Key exclusion criteria (5 listed)
- Subjects who are not regular in taking medications and who reported about aggravation of any symptoms due to exercise.(7)
- Subjects who fall in grade1 hypertension
- Subjects below the age of 30.
- History of cardiac, renal and liver diseases
- History of recent fracture or surgery.
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 |
|---|---|---|
| Jacobson's progressive muscular relaxation techniquesubjects will receive Jacobsons muscle relaxation technique. Patients will be demonstrated with the technique to contract and relax various groups of muscles, to coordinate contractions and relaxations with deep breaths and to perform the entire procedure with eyes closed in supine lying down position. Every subject will perform this supervised relaxation for 6 repetitions during a single session on once a day basis for four weeks. | Other | jacobson's progressive muscular relaxation technique |
| 30 min walk30 minutes walk twice a week for 4 weeks | Other | 30 min walk, jacobson's progressive muscular relaxation technique |
Primary outcome
changes in blood pressure
Time frame: twice a week for four weeks
subjects will receive Jacobsons muscle relaxation technique. Patients will be demonstrated with the technique to contract and relax various groups of muscles, to coordinate contractions and relaxations with deep breaths and to perform the entire procedure with eyes closed in supine lying down position. Every subject will perform this supervised relaxation for 6 repetitions during a single session on once a day basis for four weeks.
Barthel Index for Activity of daily living
Time frame: four weeks
The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.
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 14 Dec 2022.
- 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, MS principal investigator
Riphah International 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 Jacobson's progressive muscular relaxation technique and 30 min walk in people with Hypertension, 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 4 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 14 Dec 2022. 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?
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?
changes in blood pressure (time frame: twice a week for four 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 14 Dec 2022.