Elevated Blood Pressure, Hypertension
Conditions
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
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.
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
OTHERSquegg 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.
OTHERZona 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.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Trail Making Test Part A Completion Time | Baseline and Week 4. | 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. |
| Change in Trail Making Test Part B Completion Time | Baseline and Week 4. | 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. |
| Change in Montreal Cognitive Assessment Score | Baseline and Week 4. | 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. |
| Change in the Digit Symbol Substitution Test Score | Baseline and Week 4. | 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. |
| Change in Short Self-Regulation Questionnaire Score | Baseline and Week 4. | 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. |
| Change in Stroop Color and Word Test Interference Score | Baseline and Week 4. | 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. |
| Change in Stroop Word Score | Baseline and Week 4. | 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. |
| Change in Stroop Color Score | Baseline and Week 4. | 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. |
| Change in Stroop Color-Word Score | Baseline and Week 4. | 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. |
| Change in Rey Auditory Verbal Learning Test Total Acquisition Score | Baseline and Week 4. | 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. |
| Change in Rey Auditory Verbal Learning Test Learning Score | Baseline and Week 4. | 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. |
| Change in Rey Auditory Verbal Learning Test Proactive Interference Score | Baseline and Week 4. | 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. |
| Change in Rey Auditory Verbal Learning Test Retroactive Interference Score | Baseline and Week 4. | 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. |
| Change in Rey Auditory Verbal Learning Test Recognition Score | Baseline and Week 4. | 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. |
| Change in Rey Auditory Verbal Learning Test Intrusion Errors | Baseline and Week 4. | 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. |
| Change in Resting Systolic Blood Pressure | Baseline and Week 4. | 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. |
| Change in Resting Diastolic Blood Pressure | Baseline and Week 4. | 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. |
Countries
Canada
Contacts
CONTACTAva Neely, BHK
CONTACTJennifer Heisz, PhD
PRINCIPAL_INVESTIGATORJennifer Heisz, PhD
McMaster University
Outcome results
None listed