Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05240144
Other study ID # Sidra Iqbal
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2022
Est. completion date April 30, 2023

Study information

Verified date May 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
IHG
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 exercises
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 IHG
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

Locations

Country Name City State
Pakistan Comprehensive Rehabilitation Center Bahawalpur AL

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Systolic blood pressure Pressure exerted by flowing blood on walls of blood vessels during contraction of heart. 6 weeks
Primary Diastolic blood pressure Pressure exerted by flowing blood on walls of blood vessels during relaxation of heart. 6 weeks
Primary 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). 6 weeks
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A