Feasibility of a Community-Integrated Isometric Handgrip Exercise Program and Its Preliminary Effects on Blood Pressure and Cognitive Function in Older Adults

NCT07648498 | Not Yet Recruiting

• 1 other identifier: 19720
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate whether a short, supervised isometric handgrip exercise program is feasible and acceptable for older adults with elevated blood pressure or hypertension. It will also explore whether this type of exercise may improve blood pressure and cognitive function. The main questions it aims to answer are:

• Is this handgrip exercise program practical and acceptable for older adults to participate in within a community exercise setting?
• Does participation in the program lead to changes in blood pressure and cognitive function? Researchers will compare two handgrip devices to determine whether the method of delivering the exercise influences feasibility and outcomes. Participants will:
• Be randomly assigned to use one of two handgrip devices.
• Complete supervised exercise sessions twice per week for 4 weeks.
• Perform brief handgrip contractions at a set intensity during each session.
• Complete blood pressure and cognitive assessments before and after the program.

Conditions

Hypertension; Elevated Blood Pressure

Keywords

Older Adults; Isometric Handgrip Exercise; Hypertension; Feasibility; Cognition; Exercise Intervention; Blood Pressure; Community-based exercise; Pilot study; Aging; Acceptability; Handgrip training; Isometric Exercise; Cognitive function; Cardiovascular health

Outcome Measures

Primary Outcomes (11)

• Change in Physical Activity Enjoyment Scale Score

  Acceptability of the intervention will be assessed quantitatively using the change in Physical Activity Enjoyment Scale (PACES) score from baseline to post-intervention. The PACES is a self-report questionnaire consisting of 18 items rated on a 7-point Likert scale. Responses are summed to generate a total score ranging from 18 to 126, with higher positive change scores indicating greater enjoyment of physical activity and higher acceptability of the intervention.

  Baseline and Week 4.

• Qualitative Acceptability (Interviews) of the Intervention

  Acceptability of the intervention will be explored through semi-structured, one-on-one interviews conducted following post-intervention testing. Interviews will assess participants' experiences with the program, including perceived acceptability, enjoyment, burden, time commitment, ease of integration into existing routines, facilitators and barriers to adherence, sustainability, perceived effects, and overall impressions of the handgrip device. Interviews will be audio-recorded, transcribed, and analyzed using inductive thematic analysis to identify key themes related to participant experience and acceptability.

  Week 4.

• Recruitment Rate

  Feasibility of recruitment will be assessed as the number of participants enrolled in the study over the recruitment period. Recruitment rate will be calculated as the average number of participants enrolled per month (participants/month).

  Recruitment period, anticipated up to 3 months.

• Intervention Adherence (Session Attendance)

  Adherence will be assessed as the proportion of prescribed intervention sessions attended by each participant. Session attendance (%) will be calculated as the number of attended sessions divided by the total number of prescribed sessions (8 sessions over 4 weeks), multiplied by 100. Higher percentages indicate greater adherence.

  Week 4.

• High Attendance Rate

  High attendance rate will be defined as attending ≥75% of prescribed intervention sessions. This outcome will be calculated as the proportion of participants who meet or exceed this threshold, expressed as a percentage (%).

  Week 4

• Retention Rate

  Retention will be assessed as the proportion of enrolled participants who complete the post-intervention assessment. Retention rate will be calculated as the number of participants who complete follow-up testing divided by the number enrolled, multiplied by 100 to yield a percentage (%).

  Week 4.

• Protocol Fidelity

  Protocol fidelity will be assessed as the proportion of attended sessions in which participants complete the full isometric handgrip exercise protocol as prescribed (i.e., all contractions at the target intensity and duration). Fidelity will be calculated as the number of sessions completed according to protocol divided by the number of attended sessions, multiplied by 100 to yield a percentage (%). Higher values indicate greater fidelity.

  Week 4.

• Adverse Events (Safety)

  Safety will be assessed by recording the number and type of adverse events occurring during or immediately following baseline testing, intervention sessions, or post-intervention testing. The total number of adverse events will be reported as a count.

  Over the testing and intervention period, 4 weeks.

• Participant Reported Safety (Qualitative)

  Participants' perceptions of safety and comfort during the intervention will be explored through semi-structured, one-on-one interviews conducted following post-intervention testing. Responses will be analyzed qualitatively using thematic analysis.

  Week 4.

• Reasons for Withdrawal

  Reasons for withdrawal will be recorded for all participants who discontinue participation prior to completing the study. Reasons will be documented based on participant report at the time of withdrawal. Reported reasons will be reviewed and grouped into categories as appropriate during analysis. The number of withdrawals in each category will be reported as a count (number of participants), and the distribution of reasons may also be summarized descriptively.

  Over the intervention period, 4 weeks.

• Assessment Feasibility

  Feasibility of administering the cognitive and physiological assessment battery will be evaluated based on participant perceptions of the testing sessions, explored through semi-structured post-intervention interviews.

  Week 4.

Secondary Outcomes (17)

• Change in Trail Making Test Part A Completion Time

  Baseline and Week 4.

• Change in Trail Making Test Part B Completion Time

  Baseline and Week 4.

• Change in Montreal Cognitive Assessment Score

  Baseline and Week 4.

• Change in the Digit Symbol Substitution Test Score

  Baseline and Week 4.

• Change in Short Self-Regulation Questionnaire Score

  Baseline and Week 4.

Other Outcomes (4)

• Change in Handgrip Maximal Voluntary Contraction

  Baseline and Week 4.

• Change in Resting Heart Rate

  Baseline and Week 4.

• Expectancy of Cognitive Outcome

  Baseline.

Study Arms (2)

Squegg Handgrip Device

ACTIVE COMPARATOR

Participants in this arm will complete a supervised, 4-week isometric handgrip exercise intervention using the Squegg smartphone-compatible handgrip device.

Other: Squegg 4-Week Isometric Handgrip Exercise Intervention

Zona Plus Handgrip Device

ACTIVE COMPARATOR

Participants in this arm will complete a supervised, 4-week isometric handgrip exercise intervention using the Zona Plus handgrip dynamometer.

Other: Zona Plus 4-Week Isometric Handgrip Exercise Intervention

Interventions

Zona Plus 4-Week Isometric Handgrip Exercise Intervention OTHER

This intervention consists of a supervised, low-dose isometric handgrip exercise program delivered over 4 weeks using the Zona Plus handgrip dynamometer. Participants will complete two sessions per week, each consisting of 4x2-minute isometric handgrip contractions performed at 30% of maximal voluntary contraction, with 1-minute rest periods between contractions. Contractions will be performed using alternating hands. All sessions will be conducted in person and supervised by trained research staff at the Physical Activity Centre of Excellence, and the intervention will completed before participants' existing exercise routines. Ratings of perceived exertion will be recorded following each contraction.

Zona Plus Handgrip Device

Squegg 4-Week Isometric Handgrip Exercise Intervention OTHER

This intervention consists of a supervised, low-dose isometric handgrip exercise program delivered over 4 weeks using the Squegg handgrip device. Participants will complete two sessions per week, each consisting of 4x2-minute isometric handgrip contractions performed at 30% of maximal voluntary contraction, with 1-minute rest periods between contractions. Contractions will be performed using alternating hands. All sessions will be conducted in person and supervised by trained research staff at the Physical Activity Centre of Excellence, and the intervention will completed before participants' existing exercise routines. Ratings of perceived exertion will be recorded following each contraction.

Squegg Handgrip Device

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• Currently attending the Physical Activity Centre of Excellence at McMaster University
• English speaking
• Diagnosed with hypertension or elevated blood pressure

You may not qualify if:

• Current or prior participation in chronic isometric exercise
• Unstable angina.
• Uncontrolled hypertension
• Uncontrolled heart failure and/or arrhythmias
• Recent myocardial infarction or electrocardiography changes
• Complete heart block
• Carpal tunnel syndrome
• Arthritis that may be aggravated by handgrip exercise
• Changes to the type and/or dose of blood pressure medications within 3 months of starting the study.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

NeuroFit Lab, Ivor Wynne Centre, McMaster University

Hamilton, Ontario, Canada

Location

Physical Activity Centre of Excellence, Ivor Wynne Centre, McMaster University

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jennifer Heisz, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ava Neely, BHK

CONTACT

4039735863; neelya@mcmaster.ca

Jennifer Heisz, PhD

CONTACT

heiszjj@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a two-arm, parallel-group feasibility pilot trial using a 1:1 allocation ratio. Participants will be randomized to complete a 4-week, supervised isometric handgrip exercise intervention using one of two handgrip devices (Zona Plus or Squegg). The intervention will be integrated into existing community-based exercise programming at the Physical Activity Centre of Excellence (PACE). Both groups will follow an identical exercise protocol (4 × 2-minute contractions at 30% maximal voluntary contraction, twice weekly), differing only in the device used.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 28, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)