HypertensionNCT05240144
Effect of Isometric Handgrip Exercises on Blood Pressure of Hypertensive Adults
A study testing IHG and Aerobic exercises in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is designed to determine the effects of isometric handgrip exercises as compared to aerobic exercises in the hypertensive population, specifically in pre-hypertensives and those with hypertension stage I who are not taking pharmacological treatment. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- IHG and Aerobic exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2022to 30 Apr 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-hypertension (systolic BP 120-139 mmHg and diastolic BP<80) or stage I hypertensive patients (systolic BP 140-159 mmHg and diastolic BP 90-99mm Hg.
Who cannot join
- Patients who are taking antihypertensive agents
- Malignant hypertension
- Physical limitation preventing IHG training (e.g., missing arm, severe hand arthritis, carpal tunnel syndrome, or having a musculoskeletal disorder affecting the upper limb.
- Active systemic illness that restricts exercise
- People doing exercise regularly
- Any other cardiopulmonary, metabolic, neurological, or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to determine the effects of isometric handgrip exercises as compared to aerobic exercises in the hypertensive population, specifically in pre-hypertensives and those with hypertension stage I who are not taking pharmacological treatment. This exercise is designed as part of lifestyle modification for these patients and if proven effective, it can provide an easier to perform exercise regimen as an alternative to be incorporated in the exercise plan of patients who have difficulty in performing aerobic exercises because of musculoskeletal concerns.
Read the detailed description
Hypertension (HTN) is a significant public health problem, with an increasing worldwide prevalence. The disease has an impact on reducing the quality of life (QOL) and can be life-threatening if not treated early. It is considered the major risk factor for cardiovascular and renal diseases. Complications of hypertension can lead to a variety of serious diseases like stroke, heart attack, and even cardiac and renal failure. Non-pharmacological management via lifestyle modification is focused in the initial stages of HTN through the reduction in alcohol consumption, cessation of tobacco smoking, maintenance of body weight, improvements in nutrition, and increases in physical activity. Physical activity improves health status and prevents the complications of hypertension like stroke and heart failure.
Typically, aerobic exercises in the form of walking and jogging are advised as part of lifestyle modification. effectiveness of resistance training is also worked upon. A relatively newer approach in the form of Isometric Hand Grip exercises (IHG) is also under research because it can serve as a useful alternative for patients who cannot perform aerobic exercises because of musculoskeletal conditions. This study is targeted to assess the effects of IHG exercises, aerobic training, both aerobic and IHG training as well as sham IHG treatment for a comprehensive assessment of effects of IHG training.
- Conditions
- Hypertension
- Being tested
- IHG, Aerobic exercises, Sham IHG
- Keywords
- Blood pressure, Systolic blood pressure, Diastolic blood pressure, Isometric handgrip exercises, Maximal voluntary contraction
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IHGOther
Isometric handgrip exercises will be performed for 4 x 2 min with the frequency of 3 days per week for a period of 6 weeks.
Aerobic exercisesOther
Aerobic exercise according to the American College of Sports Medicine (ACSM) guidelines that provide the specific criteria as 50 minutes exercises for 3 days a week for a period of 6 weeks.
Sham IHGOther
Isometric handgrip exercises will be performed in 4 sets for 2 min at 5% MVC on both hands with the frequency of 3 days per week for a total 6-week period
| Study group | Role | What they receive |
|---|---|---|
| IHG group | Experimental | Isometric handgrip exercises will be performed in 4 sets for 2 min at 30% Maximal Voluntary Contraction (MVC) on both hands with the frequency of 3 days per week for a period of 6 weeks. Receives: Other: IHG |
| Aerobic training group | Active comparator | Aerobic Exercises include walk for 50 min with the frequency of 3 days per week. This exercise will be done for a 6-week period. Receives: Other: Aerobic exercises |
| IHG + Aerobic exercises group | Sham comparator | Isometric handgrip exercises will be performed in 4 sets for 2 min at 30% MVC on both hands with the frequency of 3 days per week for a period of 6 weeks.
Isometric handgrip exercises will be performed in 4 sets for 2 min at 30% MVC on both hands with the frequency of 3 days per week for a period of 6 weeks. Receives: Other: IHG; Other: Aerobic exercises |
| Sham IHG group | Sham comparator | Isometric handgrip exercises will be performed in 4 sets for 2 min at 5% MVC on both hands with the frequency of 3 days per week for a total 6-week period. Receives: Other: Sham IHG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Pressure exerted by flowing blood on walls of blood vessels during contraction of heart.
Measured: 6 weeks
Diastolic blood pressure
Pressure exerted by flowing blood on walls of blood vessels during relaxation of heart.
Measured: 6 weeks
Mean arterial pressure (MAP)
Mean arterial pressure (MAP) is the average of arterial pressure during one cardiac cycle and it will be calculated by using the formula MAP = DBP+ 1/3 (SBP-DBP).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start10 Sep 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240144
- Sponsor's protocol ID
- Sidra Iqbal
- Status last verified
- May 2023
- First submitted
- 4 Feb 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SH, Chae YR. Characteristics of Aerobic Exercise as Determinants of Blood Pressure Control in Hypertensive Patients: A Systematic Review and Meta-Analysis. J Korean Acad Nurs. 2020 Dec;50(6):740-756. doi: 10.4040/jkan.20169.
PubMed 33441523Palmeira AC, Farah BQ, Silva GOD, Moreira SR, Barros MVG, Correia MA, Cucato GG, Ritti-Dias RM. Effects of isometric handgrip training on blood pressure among hypertensive patients seen within public primary healthcare: a randomized controlled trial. Sao Paulo Med J. 2021 Nov 15;139(6):648-656. doi: 10.1590/1516-3180.2020.0796.R1.22042021. eCollection 2021.
PubMed 34787298Shafi ST, Shafi T. A survey of hypertension prevalence, awareness, treatment, and control in health screening camps of rural central Punjab, Pakistan. J Epidemiol Glob Health. 2017 Jun;7(2):135-140. doi: 10.1016/j.jegh.2017.01.001. Epub 2017 Feb 8.
PubMed 28188121Silva GO, Farah BQ, Germano-Soares AH, Andrade-Lima A, Santana FS, Rodrigues SL, Ritti-Dias RM. Acute blood pressure responses after different isometric handgrip protocols in hypertensive patients. Clinics (Sao Paulo). 2018 Oct 18;73:e373. doi: 10.6061/clinics/2018/e373.
PubMed 30365821Farah BQ, Germano-Soares AH, Rodrigues SLC, Santos CX, Barbosa SS, Vianna LC, Cornelissen VA, Ritti-Dias RM. Acute and Chronic Effects of Isometric Handgrip Exercise on Cardiovascular Variables in Hypertensive Patients: A Systematic Review. Sports (Basel). 2017 Aug 1;5(3):55. doi: 10.3390/sports5030055.
PubMed 29910415Herrod PJJ, Doleman B, Blackwell JEM, O'Boyle F, Williams JP, Lund JN, Phillips BE. Exercise and other nonpharmacological strategies to reduce blood pressure in older adults: a systematic review and meta-analysis. J Am Soc Hypertens. 2018 Apr;12(4):248-267. doi: 10.1016/j.jash.2018.01.008. Epub 2018 Feb 2.
PubMed 29496468
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isometric Handgrip Exercises on Blood Pressure of Hypertensive Adults
- ClinicalTrials.gov ID
- NCT05240144
- Acronym / sponsor ID
- Sidra Iqbal
- Conditions
- Hypertension
- Keywords
- Blood pressure, Systolic blood pressure, Diastolic blood pressure, Isometric handgrip exercises, Maximal voluntary contraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 15 Feb 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.
This study is designed to determine the effects of isometric handgrip exercises as compared to aerobic exercises in the hypertensive population, specifically in pre-hypertensives and those with hypertension stage I who are not taking pharmacological treatment. This exercise is designed as part of lifestyle modification for these patients and if proven effective, it can provide an easier to perform exercise regimen as an alternative to be incorporated in the exercise plan of patients who have difficulty in performing aerobic exercises because of musculoskeletal concerns.
Detailed description
Hypertension (HTN) is a significant public health problem, with an increasing worldwide prevalence. The disease has an impact on reducing the quality of life (QOL) and can be life-threatening if not treated early. It is considered the major risk factor for cardiovascular and renal diseases. Complications of hypertension can lead to a variety of serious diseases like stroke, heart attack, and even cardiac and renal failure. Non-pharmacological management via lifestyle modification is focused in the initial stages of HTN through the reduction in alcohol consumption, cessation of tobacco smoking, maintenance of body weight, improvements in nutrition, and increases in physical activity. Physical activity improves health status and prevents the complications of hypertension like stroke and heart failure.
Typically, aerobic exercises in the form of walking and jogging are advised as part of lifestyle modification. effectiveness of resistance training is also worked upon. A relatively newer approach in the form of Isometric Hand Grip exercises (IHG) is also under research because it can serve as a useful alternative for patients who cannot perform aerobic exercises because of musculoskeletal conditions. This study is targeted to assess the effects of IHG exercises, aerobic training, both aerobic and IHG training as well as sham IHG treatment for a comprehensive assessment of effects of IHG training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IHG group | Experimental | Other: IHGIsometric handgrip exercises will be performed in 4 sets for 2 min at 30% Maximal Voluntary Contraction (MVC) on both hands with the frequency of 3 days per week for a period of 6 weeks. |
| Aerobic training group | Active comparator | Other: Aerobic exercisesAerobic Exercises include walk for 50 min with the frequency of 3 days per week. This exercise will be done for a 6-week period. |
| IHG + Aerobic exercises group | Sham comparator | Other: IHG, Other: Aerobic exercisesIsometric handgrip exercises will be performed in 4 sets for 2 min at 30% MVC on both hands with the frequency of 3 days per week for a period of 6 weeks. Isometric handgrip exercises will be performed in 4 sets for 2 min at 30% MVC on both hands with the frequency of 3 days per week for a period of 6 weeks. |
| Sham IHG group | Sham comparator | Other: Sham IHGIsometric handgrip exercises will be performed in 4 sets for 2 min at 5% MVC on both hands with the frequency of 3 days per week for a total 6-week period. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-hypertension (systolic BP 120-139 mmHg and diastolic BP<80) or stage I hypertensive patients (systolic BP 140-159 mmHg and diastolic BP 90-99mm Hg.
Key exclusion criteria (6 listed)
- Patients who are taking antihypertensive agents
- Malignant hypertension
- Physical limitation preventing IHG training (e.g., missing arm, severe hand arthritis, carpal tunnel syndrome, or having a musculoskeletal disorder affecting the upper limb.
- Active systemic illness that restricts exercise
- People doing exercise regularly
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 |
|---|---|---|
| IHGIsometric handgrip exercises will be performed for 4 x 2 min with the frequency of 3 days per week for a period of 6 weeks. | Other | IHG + Aerobic exercises group, IHG group |
| Aerobic exercisesAerobic exercise according to the American College of Sports Medicine (ACSM) guidelines that provide the specific criteria as 50 minutes exercises for 3 days a week for a period of 6 weeks. | Other | Aerobic training group, IHG + Aerobic exercises group |
| Sham IHGIsometric handgrip exercises will be performed in 4 sets for 2 min at 5% MVC on both hands with the frequency of 3 days per week for a total 6-week period | Other | Sham IHG group |
Primary outcome
Systolic blood pressure
Time frame: 6 weeks
Pressure exerted by flowing blood on walls of blood vessels during contraction of heart.
Diastolic blood pressure
Time frame: 6 weeks
Pressure exerted by flowing blood on walls of blood vessels during relaxation of heart.
Mean arterial pressure (MAP)
Time frame: 6 weeks
Mean arterial pressure (MAP) is the average of arterial pressure during one cardiac cycle and it will be calculated by using the formula MAP = DBP+ 1/3 (SBP-DBP).
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 6 May 2023.
- Background: PubMed 33441523Lee SH, Chae YR. Characteristics of Aerobic Exercise as Determinants of Blood Pressure Control in Hypertensive Patients: A Systematic Review and Meta-Analysis. J Korean Acad Nurs. 2020 Dec;50(6):740-756. doi: 10.4040/jkan.20169.
- Background: PubMed 34787298Palmeira AC, Farah BQ, Silva GOD, Moreira SR, Barros MVG, Correia MA, Cucato GG, Ritti-Dias RM. Effects of isometric handgrip training on blood pressure among hypertensive patients seen within public primary healthcare: a randomized controlled trial. Sao Paulo Med J. 2021 Nov 15;139(6):648-656. doi: 10.1590/1516-3180.2020.0796.R1.22042021. eCollection 2021.
- Background: PubMed 28188121Shafi ST, Shafi T. A survey of hypertension prevalence, awareness, treatment, and control in health screening camps of rural central Punjab, Pakistan. J Epidemiol Glob Health. 2017 Jun;7(2):135-140. doi: 10.1016/j.jegh.2017.01.001. Epub 2017 Feb 8.
- Background: PubMed 30365821Silva GO, Farah BQ, Germano-Soares AH, Andrade-Lima A, Santana FS, Rodrigues SL, Ritti-Dias RM. Acute blood pressure responses after different isometric handgrip protocols in hypertensive patients. Clinics (Sao Paulo). 2018 Oct 18;73:e373. doi: 10.6061/clinics/2018/e373.
- Background: PubMed 29910415Farah BQ, Germano-Soares AH, Rodrigues SLC, Santos CX, Barbosa SS, Vianna LC, Cornelissen VA, Ritti-Dias RM. Acute and Chronic Effects of Isometric Handgrip Exercise on Cardiovascular Variables in Hypertensive Patients: A Systematic Review. Sports (Basel). 2017 Aug 1;5(3):55. doi: 10.3390/sports5030055.
- Background: PubMed 29496468Herrod PJJ, Doleman B, Blackwell JEM, O'Boyle F, Williams JP, Lund JN, Phillips BE. Exercise and other nonpharmacological strategies to reduce blood pressure in older adults: a systematic review and meta-analysis. J Am Soc Hypertens. 2018 Apr;12(4):248-267. doi: 10.1016/j.jash.2018.01.008. Epub 2018 Feb 2.
- 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.
Suman Sheraz, PhD* 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 IHG and Aerobic exercises 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 1 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: finished, as of the sponsor's last update on 6 May 2023. 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. Some participants in this study may receive a placebo. 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?
Systolic blood pressure (time frame: 6 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 NCT05240144, which also lists 6 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 6 May 2023.