- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05240144
Effect of Isometric Handgrip Exercises on Blood Pressure of Hypertensive Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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AL
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Bahawalpur, AL, Pakistan, 44000
- Comprehensive Rehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IHG group
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.
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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.
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|
Active Comparator: Aerobic training group
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.
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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 Comparator: IHG + Aerobic exercises group
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. |
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 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 Comparator: Sham IHG group
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic blood pressure
Time Frame: 6 weeks
|
Pressure exerted by flowing blood on walls of blood vessels during contraction of heart.
|
6 weeks
|
|
Diastolic blood pressure
Time Frame: 6 weeks
|
Pressure exerted by flowing blood on walls of blood vessels during relaxation of heart.
|
6 weeks
|
|
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).
|
6 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Palmeira 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.
- Shafi 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.
- Silva 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.
- Farah 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.
- Herrod 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sidra Iqbal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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