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

Overview

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.

Detailed description

This study is a two-arm, parallel-group feasibility pilot trial designed to evaluate the feasibility, acceptability, and safety of a supervised isometric handgrip exercise program for older adults with elevated blood pressure or hypertension in a community setting. Participants will be recruited from the Physical Activity Centre of Excellence at McMaster University and randomized in a 1:1 ratio to one of two intervention arms, which differ only by the handgrip device used (Zona Plus or Squegg).

The intervention will be delivered over 4 weeks and integrated into participants' existing exercise routines at PACE. All participants will complete supervised sessions twice weekly, with each session consisting of four 2-minute isometric handgrip contractions at 30% of maximal voluntary contraction, with standardized rest periods between contractions. Sessions will be supervised by trained research staff to ensure adherence to the protocol and participant safety.

Feasibility outcomes will include recruitment rate, session attendance (adherence), retention, and protocol fidelity. Acceptability will be assessed using a standardized questionnaire and semi-structured exit interviews to capture participants' experiences, perceived burden, and integration into existing routines. Safety will be evaluated through the monitoring and documentation of adverse events.

Exploratory outcomes will include changes in resting blood pressure and cognitive function assessed before and after the intervention using standardized measures. Quantitative data will be analyzed descriptively to assess feasibility outcomes, with exploratory analyses conducted to examine pre-post changes. Qualitative data will be analyzed using inductive thematic analysis to identify key themes related to participant experience.

Interventions

• Other Zona Plus 4-Week Isometric Handgrip Exercise Intervention
  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 st
• Other Squegg 4-Week Isometric Handgrip Exercise Intervention
  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 t

Primary outcome measures

• Change in Physical Activity Enjoyment Scale Score [Time frame: Baseline and Week 4.]
• Qualitative Acceptability (Interviews) of the Intervention [Time frame: Week 4.]
• Recruitment Rate [Time frame: Recruitment period, anticipated up to 3 months.]
• Intervention Adherence (Session Attendance) [Time frame: Week 4.]
• High Attendance Rate [Time frame: Week 4]
• Retention Rate [Time frame: Week 4.]
• Protocol Fidelity [Time frame: Week 4.]
• Adverse Events (Safety) [Time frame: Over the testing and intervention period, 4 weeks.]
• Participant Reported Safety (Qualitative) [Time frame: Week 4.]
• Reasons for Withdrawal [Time frame: Over the intervention period, 4 weeks.]

Secondary outcome measures (12)

• Change in Trail Making Test Part A Completion Time [Time frame: Baseline and Week 4.]
• Change in Trail Making Test Part B Completion Time [Time frame: Baseline and Week 4.]
• Change in Montreal Cognitive Assessment Score [Time frame: Baseline and Week 4.]
• Change in the Digit Symbol Substitution Test Score [Time frame: Baseline and Week 4.]
• Change in Short Self-Regulation Questionnaire Score [Time frame: Baseline and Week 4.]
• Change in Stroop Color and Word Test Interference Score [Time frame: Baseline and Week 4.]
• Change in Stroop Word Score [Time frame: Baseline and Week 4.]
• Change in Stroop Color Score [Time frame: Baseline and Week 4.]
• Change in Stroop Color-Word Score [Time frame: Baseline and Week 4.]
• Change in Rey Auditory Verbal Learning Test Total Acquisition Score [Time frame: Baseline and Week 4.]
• Change in Rey Auditory Verbal Learning Test Learning Score [Time frame: Baseline and Week 4.]
• Change in Rey Auditory Verbal Learning Test Proactive Interference Score [Time frame: Baseline and Week 4.]

Eligibility criteria

Inclusion criteria

• 65 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Canada · 2 centers

• NeuroFit Lab, Ivor Wynne Centre, McMaster University — Hamilton
• Physical Activity Centre of Excellence, Ivor Wynne Centre, McMaster University — Hamilton

Identifiers

NCT: NCT07648498 · 19720

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗