HypertensionNCT07648498
Feasibility of a Community-Integrated Isometric Handgrip Exercise Program and Its Preliminary Effects on Blood Pressure and Cognitive Function in Older Adults
A study testing Zona Plus 4-Week Isometric Handgrip Exercise Intervention and Squegg 4-Week Isometric Handgrip Exercise Intervention in people with Hypertension and Elevated Blood Pressure, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Elevated Blood Pressure
- What is being tested?
- Zona Plus 4-Week Isometric Handgrip Exercise Intervention and Squegg 4-Week Isometric Handgrip Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Aug 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Heisz, PhD contact
Canada2 sites, 2 recruiting
- Recruiting
NeuroFit Lab, Ivor Wynne Centre, McMaster University
Hamilton, Ontario
Jennifer Heisz, PhD, 905-525-9140 ext. 21944, heiszjj@mcmaster.ca
Ava Neely, BHK
- Recruiting
Physical Activity Centre of Excellence, Ivor Wynne Centre, McMaster University
Hamilton, Ontario
Jennifer Heisz, PhD, 905-525-9140 ext. 21944, heiszjj@mcmaster.ca
Ava Neely, BHK
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Hypertension, Elevated Blood Pressure
- Being tested
- Zona Plus 4-Week Isometric Handgrip Exercise Intervention, Squegg 4-Week Isometric Handgrip Exercise Intervention
- 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
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zona Plus 4-Week Isometric Handgrip Exercise InterventionOther
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 InterventionOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Zona Plus 4-Week Isometric Handgrip Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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 (%).
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4.
Secondary outcomes (17)
Change in Trail Making Test Part A Completion Time
Participants are asked to connect numbered circles in sequential order (1-2-3, etc.) as quickly as possible. This test assesses processing speed. Performance is measured as the total time in seconds (s) required to complete the task. Lower completion time indicates better performance.
Measured: Baseline and Week 4.
Change in Trail Making Test Part B Completion Time
Participants are asked to alternate between numbers and letters in sequence (e.g., 1-A-2-B, etc.) while connecting circles as quickly as possible. This test assesses executive function and cognitive flexibility. Performance is measured as the total time in seconds (s) required to complete the task. Lower completion time indicates better performance.
Measured: Baseline and Week 4.
Change in Montreal Cognitive Assessment Score
The Montreal Cognitive Assessment (MoCA) is a brief screening tool used to assess global cognitive function across multiple domains, including memory, attention, language, and executive function. It consists of a series of tasks, with scores ranging from 0 to 30, where higher scores indicate better cognitive function.
Measured: Baseline and Week 4.
Change in the Digit Symbol Substitution Test Score
Participants are given a key pairing numbers with symbols and are asked to match as many symbols to the corresponding numbers as possible within a fixed time period. This test assesses processing speed. Performance is measured as the number of correct responses completed within the time limit, reported as a count (number of correct responses), with higher scores indicating greater performance.
Measured: Baseline and Week 4.
Change in Short Self-Regulation Questionnaire Score
The Short Self-Regulation Questionnaire is a self-report measure that assesses an individual's ability to regulate their thoughts, emotions, and behaviors. Participants respond to a series of statements using a 5-point Likert scale, and responses are summed to generate a total score. Scores range from 31-155, with higher scores indicating greater self-regulation.
Measured: Baseline and Week 4.
Change in Stroop Color and Word Test Interference Score
Interference score will be calculated using the paper-and-pencil Stroop Color and Word Test (Golden version). The interference score will be calculated using the Golden method, where predicted Color-Word performance is derived as (W × C) / (W + C), and interference is calculated as the difference between actual and predicted Color-Word scores (CW - [(W × C) / (W + C)]). Higher scores indicate better inhibitory control.
Measured: Baseline and Week 4.
Change in Stroop Word Score
Number of correct responses in the Stroop Word condition completed within 45 seconds using the paper-and-pencil Stroop Color and Word Test (Golden version). Higher scores indicate better performance.
Measured: Baseline and Week 4.
Change in Stroop Color Score
Number of correct responses in the Stroop Color condition completed within 45 seconds using the paper-and-pencil Stroop Color and Word Test (Golden version). Higher scores indicate better performance.
Measured: Baseline and Week 4.
Change in Stroop Color-Word Score
Number of correct responses in the Stroop Color-Word condition completed within 45 seconds using the paper-and-pencil Stroop Color and Word Test (Golden version). Higher scores indicate better performance.
Measured: Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Total Acquisition Score
The Rey Auditory Verbal Learning Test is used to assess verbal learning and memory. Participants are read a list of 15 words over five learning trials and asked to recall as many words as possible after each trial. Total acquisition score is calculated as the total number of correctly recalled words across the five learning trials, with higher scores indicating better verbal learning performance.
Measured: Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Learning Score
The Rey Auditory Verbal Learning Test is used to assess verbal learning and memory. Participants are read a list of 15 words over 5 learning trials and asked to recall as many words as possible after each trial. Learning score reflects improvement in recall performance across learning trials, with higher scores indicating greater learning efficiency.
Measured: Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Proactive Interference Score
The Rey Auditory Verbal Learning Test is used to assess verbal learning and memory. Following repeated learning trials of an initial word list, participants are presented with an interference list (List B). Proactive interference score is calculated as Trial 1 recall minus List B recall and reflects the extent to which previously learned information interferes with learning new information. Higher scores indicate greater proactive interference.
Measured: Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Retroactive Interference Score
The Rey Auditory Verbal Learning Test is used to assess verbal learning and memory. After presentation of an interference list (List B), participants are asked to recall words from the original list. Retroactive interference score is calculated as Trial 5 recall minus Trial 6 recall and reflects the extent to which new information interferes with recall of previously learned information. Higher scores indicate greater retroactive interference.
Measured: Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Recognition Score
The Rey Auditory Verbal Learning Test is used to assess verbal learning and memory. Following delayed recall, participants complete a recognition trial in which they identify previously presented words from a list of target and distractor words. Performance is measured as the number of correctly recognized target words, with higher scores indicating better recognition memory.
Measured: Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Intrusion Errors
The Rey Auditory Verbal Learning Test is used to assess verbal learning and memory. Intrusion errors are defined as recalled words that were not included in the target word list during recall trials. Performance is measured as the total number of intrusion errors, with lower scores indicating better performance.
Measured: Baseline and Week 4.
Change in Resting Systolic Blood Pressure
Resting systolic blood pressure will be measured using an automated device on the right arm following a 5-minute seated rest period. After the initial measurement, a second and third measurement will be taken, each separated by a 1-minute rest interval. Blood pressure will be recorded in millimeters of mercury (mmHg), with higher values indicating higher systolic blood pressure.
Measured: Baseline and Week 4.
Change in Resting Diastolic Blood Pressure
Resting diastolic blood pressure will be measured using an automated device on the right arm following a 5-minute seated rest period. After the initial measurement, a second and third measurement will be taken, each separated by a 1-minute rest interval. Blood pressure will be recorded in millimeters of mercury (mmHg), with higher values indicating higher diastolic blood pressure.
Measured: Baseline and Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start18 Aug 2026
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Heisz, McMaster University
- Investigators
- Jennifer Heisz, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648498
- Sponsor's protocol ID
- 19720
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Community-Integrated Isometric Handgrip Exercise Program and Its Preliminary Effects on Blood Pressure and Cognitive Function in Older Adults
- ClinicalTrials.gov ID
- NCT07648498
- Acronym / sponsor ID
- 19720
- Conditions
- Hypertension, Elevated Blood Pressure
- Keywords
- Older Adults, Isometric Handgrip Exercise, Hypertension, Feasibility, Cognition, Exercise Intervention, Blood Pressure, Community-based exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Squegg Handgrip Device | Active comparator | Other: Squegg 4-Week Isometric Handgrip Exercise InterventionParticipants in this arm will complete a supervised, 4-week isometric handgrip exercise intervention using the Squegg smartphone-compatible handgrip device. |
| Zona Plus Handgrip Device | Active comparator | Other: Zona Plus 4-Week Isometric Handgrip Exercise InterventionParticipants in this arm will complete a supervised, 4-week isometric handgrip exercise intervention using the Zona Plus handgrip dynamometer. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Current or prior participation in chronic isometric exercise
- Unstable angina.
- Uncontrolled hypertension
- Uncontrolled heart failure and/or arrhythmias
- Recent myocardial infarction or electrocardiography changes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zona Plus 4-Week Isometric Handgrip Exercise InterventionThis 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. | Other | Zona Plus Handgrip Device |
| Squegg 4-Week Isometric Handgrip Exercise InterventionThis 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. | Other | Squegg Handgrip Device |
Primary outcome
Change in Physical Activity Enjoyment Scale Score
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
17 secondary outcomes
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.
Change in Rey Auditory Verbal Learning Test Retroactive Interference Score
Time frame: Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Recognition Score
Time frame: Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Intrusion Errors
Time frame: Baseline and Week 4.
Change in Resting Systolic Blood Pressure
Time frame: Baseline and Week 4.
Change in Resting Diastolic Blood Pressure
Time frame: Baseline and Week 4.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Pheochromocytoma, Paraganglioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Heisz, PhD contact
Jennifer Heisz, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zona Plus 4-Week Isometric Handgrip Exercise Intervention and Squegg 4-Week Isometric Handgrip Exercise Intervention in people with Hypertension and Elevated Blood Pressure, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ava Neely, BHK (4039735863, neelya@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity Enjoyment Scale Score (time frame: Baseline and Week 4.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.