NCT05240144

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

September 10, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

February 4, 2022

Last Update Submit

May 3, 2023

Conditions

Hypertension

Keywords

Blood pressureSystolic blood pressureDiastolic blood pressureIsometric handgrip exercisesMaximal voluntary contraction

Outcome Measures

Primary Outcomes (3)

  • Systolic blood pressure

    Pressure exerted by flowing blood on walls of blood vessels during contraction of heart.

    6 weeks

  • Diastolic blood pressure

    Pressure exerted by flowing blood on walls of blood vessels during relaxation of heart.

    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).

    6 weeks

Study Arms (4)

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.

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.

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.

Other: IHGOther: 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.

Other: Sham IHG

Interventions

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.

IHG + Aerobic exercises groupIHG group
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.

Aerobic training groupIHG + Aerobic exercises group
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

Sham IHG group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Rehabilitation Center

Bahawalpur, AL, 44000, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 33441523BACKGROUND

  • 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.

    PMID: 34787298BACKGROUND

  • 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.

    PMID: 28188121BACKGROUND

  • 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.

    PMID: 30365821BACKGROUND

  • 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.

    PMID: 29910415BACKGROUND

  • 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.

    PMID: 29496468BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 15, 2022

Study Start

September 10, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)