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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 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 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 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.

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (2)

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