HypertensionNCT05110365
Effect of Proprioceptive Neuromuscular Facilitation on Blood Pressure
A study testing Proprioceptive Neuromuscular Facilitation in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effect of Proprioceptive Neuromuscular Facilitation exercise on blood pressure in patient with mild to moderate hypertension.Both genders will be included.Patients aged between 40 and 60 years with mild and moderate hypertension.Systolic blood pressure 130-160 mmHg or Diastolic Blood Pressure 80-100… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Proprioceptive Neuromuscular Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Jun 2021to 18 Aug 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders will be included.
- Patients aged between 40 and 60 years with mild and moderate hypertension.
- Systolic blood pressure 130-160 mmHg or Diastolic blood pressure 80-100 mmHg.
- Mild and moderate hypertension with diabetes
Who cannot join
- Severe hypertensive patients.
- Patient on smoking
- Patient with severe complications and comorbidities.
- Not willing to give consent/ data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Proprioceptive Neuromuscular Facilitation Exercise on Blood Pressure and Ankle Brachial Index in Patient With Hypertension
To determine the effect of Proprioceptive Neuromuscular Facilitation exercise on blood pressure in patient with mild to moderate hypertension.Both genders will be included.Patients aged between 40 and 60 years with mild and moderate hypertension.Systolic blood pressure 130-160 mmHg or Diastolic Blood Pressure 80-100 mmHg.
Sphygmomanometer and EuroQoL five-dimensional instrument would be used for the 'Pre' \& 'Post' assessment.
Read the detailed description
There is a belief that proprioceptive neuromuscular facilitation exercises cause cardiac overload as blood pressure in immediately influenced by exercise but Pereira concluded in his research that proprioceptive neuromuscular facilitation exercises with minimum repetitions are safe for hypertensive or cardiovascular patients because in his study there is no increase in blood pressure in older women after performing three different types of PNF exercises. Pereira discovered that rhythmic initiation , dynamic reversals , and combination of isotonic techniques did not raise blood pressure levels, thus it is recommended to use up to five repeats of repetition maximum . One study observed at the effects of passive and modified proprioceptive neuromuscular facilitation (PNF)stretching techniques on acute systolic and diastolic blood pressure responses. All PNF treatments were beneficial in increasing Range of motion, as we all know.
PNF improves Range Of Motion while avoiding an increase in Systolic blood pressure in one or two trials, but increases Systolic blood pressure in a third trial. Blood pressure rises by 40% with conventional exercise programmers and because PNF involves near-maximal resistance,researchers anticipated a considerable rise in blood pressure during PNF execution. It was discovered that elderly subjects could not readily execute more than five to seven repetitions of PNF exercises, which has also been shown by others. Due to the low repetition number of each movement pattern, the results showed that PNF did not induce a high enough workload to increase blood pressure in the elderly.
- Conditions
- Hypertension
- Being tested
- Proprioceptive Neuromuscular Facilitation
- Keywords
- proprioceptive neuromuscular facilitations, ankle brachial index, diabetes
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular FacilitationOther
The patient will be provided with mild to moderate resistance PNF pattern which is a type of Endurance training which decreases BP through a reduction in systemic vascular resistance(15).In a regimen as follow with the frequency of 3 days a week, a repetition of 3 sets for one hour and a total duration of 3 months(16). The PNF patterns will be diagonal 1 (D1) and diagonal 2 (D2) patterns. Both patterns are subdivided into: A) Moving into Flexion: the toes start flexed and ends extended. Ankle and foot start plantar flexed; everted and ends dorsiflexed inverted. Tibia starts externally rotated and ends internally rotated. Knee starts extended, and ends flexed. The hip starts extended, abducted, internally rotated and ends flexed, adducted, externally rotated.B) Moving into Extension: The start and end are reversed to "D1 Moving into Flexion"
| Study group | Role | What they receive |
|---|---|---|
| proprioceptive neuromuscular facilitation | Experimental | proprioceptive neuromuscular facilitation techniques Receives: Other: Proprioceptive Neuromuscular Facilitation |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
sphygmomanometer
sphygmomanometer will be used for measuring blood pressure and ankle brachial index
Measured: 12 weeks
Secondary outcomes (1)
(EuroQoL five-dimensional instrument )
quality of life measures the five dimension mobility,selfcare,usual activities,pain and anxiety.
0 for minimum 5 for maximum
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start26 Jun 2021
- Primary completion15 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sania aziz, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110365
- Sponsor's protocol ID
- REC/01045 Raja Saddam
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Linke A, Erbs S, Hambrecht R. Effects of exercise training upon endothelial function in patients with cardiovascular disease. Front Biosci. 2008 Jan 1;13:424-32. doi: 10.2741/2689.
PubMed 17981557Papaioannou TG, Oikonomou E, Lazaros G, Christoforatou E, Vogiatzi G, Tsalamandris S, Chasikidis C, Kalambogias A, Mavratzas T, Stofa E, Mystakidi VC, Latsios G, Deftereos S, Tousoulis D. Arterial stiffness and subclinical aortic damage of reclassified subjects as stage 1 hypertension according to the new 2017 ACC/AHA blood pressure guidelines. Vasa. 2019 May;48(3):236-243. doi: 10.1024/0301-1526/a000765. Epub 2018 Dec 10.
PubMed 30526401Varounis C, Katsi V, Nihoyannopoulos P, Lekakis J, Tousoulis D. Cardiovascular Hypertensive Crisis: Recent Evidence and Review of the Literature. Front Cardiovasc Med. 2017 Jan 10;3:51. doi: 10.3389/fcvm.2016.00051. eCollection 2016.
PubMed 28119918Singh S, Shankar R, Singh GP. Prevalence and Associated Risk Factors of Hypertension: A Cross-Sectional Study in Urban Varanasi. Int J Hypertens. 2017;2017:5491838. doi: 10.1155/2017/5491838. Epub 2017 Dec 3.
PubMed 29348933Papadopoulos DP, Sanidas EA, Viniou NA, Gennimata V, Chantziara V, Barbetseas I, Makris TK. Cardiovascular hypertensive emergencies. Curr Hypertens Rep. 2015 Feb;17(2):5. doi: 10.1007/s11906-014-0515-z.
PubMed 25620633Hindle KB, Whitcomb TJ, Briggs WO, Hong J. Proprioceptive Neuromuscular Facilitation (PNF): Its Mechanisms and Effects on Range of Motion and Muscular Function. J Hum Kinet. 2012 Mar;31:105-13. doi: 10.2478/v10078-012-0011-y. Epub 2012 Apr 3.
PubMed 23487249Kim EK, Lee DK, Kim YM. Effects of aquatic PNF lower extremity patterns on balance and ADL of stroke patients. J Phys Ther Sci. 2015 Jan;27(1):213-5. doi: 10.1589/jpts.27.213. Epub 2015 Jan 9.
PubMed 25642076Pereira MP. Proprioceptive neuromuscular facilitation does not increase blood pressure of healthy elderly women. Physiother Theory Pract. 2012 Jul;28(5):412-6. doi: 10.3109/09593985.2011.609582. Epub 2011 Oct 18.
PubMed 22007735Fagard RH, Cornelissen VA. Effect of exercise on blood pressure control in hypertensive patients. Eur J Cardiovasc Prev Rehabil. 2007 Feb;14(1):12-7. doi: 10.1097/HJR.0b013e3280128bbb.
PubMed 17301622
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Neuromuscular Facilitation Exercise on Blood Pressure and Ankle Brachial Index in Patient With Hypertension
- ClinicalTrials.gov ID
- NCT05110365
- Acronym / sponsor ID
- REC/01045 Raja Saddam
- Conditions
- Hypertension
- Keywords
- proprioceptive neuromuscular facilitations, ankle brachial index, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 5 Nov 2021 (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.
To determine the effect of Proprioceptive Neuromuscular Facilitation exercise on blood pressure in patient with mild to moderate hypertension.Both genders will be included.Patients aged between 40 and 60 years with mild and moderate hypertension.Systolic blood pressure 130-160 mmHg or Diastolic Blood Pressure 80-100 mmHg.
Sphygmomanometer and EuroQoL five-dimensional instrument would be used for the 'Pre' \& 'Post' assessment.
Detailed description
There is a belief that proprioceptive neuromuscular facilitation exercises cause cardiac overload as blood pressure in immediately influenced by exercise but Pereira concluded in his research that proprioceptive neuromuscular facilitation exercises with minimum repetitions are safe for hypertensive or cardiovascular patients because in his study there is no increase in blood pressure in older women after performing three different types of PNF exercises. Pereira discovered that rhythmic initiation , dynamic reversals , and combination of isotonic techniques did not raise blood pressure levels, thus it is recommended to use up to five repeats of repetition maximum . One study observed at the effects of passive and modified proprioceptive neuromuscular facilitation (PNF)stretching techniques on acute systolic and diastolic blood pressure responses. All PNF treatments were beneficial in increasing Range of motion, as we all know.
PNF improves Range Of Motion while avoiding an increase in Systolic blood pressure in one or two trials, but increases Systolic blood pressure in a third trial. Blood pressure rises by 40% with conventional exercise programmers and because PNF involves near-maximal resistance,researchers anticipated a considerable rise in blood pressure during PNF execution. It was discovered that elderly subjects could not readily execute more than five to seven repetitions of PNF exercises, which has also been shown by others. Due to the low repetition number of each movement pattern, the results showed that PNF did not induce a high enough workload to increase blood pressure in the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proprioceptive neuromuscular facilitation | Experimental | Other: Proprioceptive Neuromuscular Facilitationproprioceptive neuromuscular facilitation techniques |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders will be included.
- Patients aged between 40 and 60 years with mild and moderate hypertension.
- Systolic blood pressure 130-160 mmHg or Diastolic blood pressure 80-100 mmHg.
- Mild and moderate hypertension with diabetes
Key exclusion criteria (4 listed)
- Severe hypertensive patients.
- Patient on smoking
- Patient with severe complications and comorbidities.
- Not willing to give consent/ data
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 |
|---|---|---|
| Proprioceptive Neuromuscular FacilitationThe patient will be provided with mild to moderate resistance PNF pattern which is a type of Endurance training which decreases BP through a reduction in systemic vascular resistance(15).In a regimen as follow with the frequency of 3 days a week, a repetition of 3 sets for one hour and a total duration of 3 months(16). The PNF patterns will be diagonal 1 (D1) and diagonal 2 (D2) patterns. Both patterns are subdivided into: A) Moving into Flexion: the toes start flexed and ends extended. Ankle and foot start plantar flexed; everted and ends dorsiflexed inverted. Tibia starts externally rotated and ends internally rotated. Knee starts extended, and ends flexed. The hip starts extended, abducted, internally rotated and ends flexed, adducted, externally rotated.B) Moving into Extension: The start and end are reversed to "D1 Moving into Flexion" | Other | proprioceptive neuromuscular facilitation |
Primary outcome
sphygmomanometer
Time frame: 12 weeks
sphygmomanometer will be used for measuring blood pressure and ankle brachial index
1 secondary outcome
(EuroQoL five-dimensional instrument )
Time frame: 12 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 23 Sep 2022.
- Background: PubMed 17981557Linke A, Erbs S, Hambrecht R. Effects of exercise training upon endothelial function in patients with cardiovascular disease. Front Biosci. 2008 Jan 1;13:424-32. doi: 10.2741/2689.
- Background: PubMed 30526401Papaioannou TG, Oikonomou E, Lazaros G, Christoforatou E, Vogiatzi G, Tsalamandris S, Chasikidis C, Kalambogias A, Mavratzas T, Stofa E, Mystakidi VC, Latsios G, Deftereos S, Tousoulis D. Arterial stiffness and subclinical aortic damage of reclassified subjects as stage 1 hypertension according to the new 2017 ACC/AHA blood pressure guidelines. Vasa. 2019 May;48(3):236-243. doi: 10.1024/0301-1526/a000765. Epub 2018 Dec 10.
- Background: PubMed 28119918Varounis C, Katsi V, Nihoyannopoulos P, Lekakis J, Tousoulis D. Cardiovascular Hypertensive Crisis: Recent Evidence and Review of the Literature. Front Cardiovasc Med. 2017 Jan 10;3:51. doi: 10.3389/fcvm.2016.00051. eCollection 2016.
- Background: PubMed 29348933Singh S, Shankar R, Singh GP. Prevalence and Associated Risk Factors of Hypertension: A Cross-Sectional Study in Urban Varanasi. Int J Hypertens. 2017;2017:5491838. doi: 10.1155/2017/5491838. Epub 2017 Dec 3.
- Background: PubMed 25620633Papadopoulos DP, Sanidas EA, Viniou NA, Gennimata V, Chantziara V, Barbetseas I, Makris TK. Cardiovascular hypertensive emergencies. Curr Hypertens Rep. 2015 Feb;17(2):5. doi: 10.1007/s11906-014-0515-z.
- Background: PubMed 23487249Hindle KB, Whitcomb TJ, Briggs WO, Hong J. Proprioceptive Neuromuscular Facilitation (PNF): Its Mechanisms and Effects on Range of Motion and Muscular Function. J Hum Kinet. 2012 Mar;31:105-13. doi: 10.2478/v10078-012-0011-y. Epub 2012 Apr 3.
- Background: PubMed 25642076Kim EK, Lee DK, Kim YM. Effects of aquatic PNF lower extremity patterns on balance and ADL of stroke patients. J Phys Ther Sci. 2015 Jan;27(1):213-5. doi: 10.1589/jpts.27.213. Epub 2015 Jan 9.
- Background: PubMed 22007735Pereira MP. Proprioceptive neuromuscular facilitation does not increase blood pressure of healthy elderly women. Physiother Theory Pract. 2012 Jul;28(5):412-6. doi: 10.3109/09593985.2011.609582. Epub 2011 Oct 18.
- Background: PubMed 17301622Fagard RH, Cornelissen VA. Effect of exercise on blood pressure control in hypertensive patients. Eur J Cardiovasc Prev Rehabil. 2007 Feb;14(1):12-7. doi: 10.1097/HJR.0b013e3280128bbb.
- 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.
sania aziz, MSNMPT 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 Proprioceptive Neuromuscular Facilitation 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 4 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 23 Sep 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?
sphygmomanometer (time frame: 12 weeks). 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 NCT05110365, which also lists 9 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 23 Sep 2022.