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

2026年6月11日 更新者：Jennifer Heisz、McMaster University

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 加拿大
    • Ontario
      • Hamilton、Ontario、加拿大
        • NeuroFit Lab, Ivor Wynne Centre, McMaster University
        • 接触：
        • 副研究员：
          • Ava Neely, BHK
        • 副研究员：
          • Alyssandra Mammoliti
        • 首席研究员：
          • Jennifer Heisz, PhD
      • Hamilton、Ontario、加拿大
        • Physical Activity Centre of Excellence, Ivor Wynne Centre, McMaster University
        • 接触：
        • 副研究员：
          • Ava Neely, BHK
        • 副研究员：
          • Alyssandra Mammoliti
        • 首席研究员：
          • Jennifer Heisz, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Squegg Handgrip Device
Participants in this arm will complete a supervised, 4-week isometric handgrip exercise intervention using the Squegg smartphone-compatible handgrip device.
其他：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.
有源比较器：Zona Plus Handgrip Device
Participants in this arm will complete a supervised, 4-week isometric handgrip exercise intervention using the Zona Plus handgrip dynamometer.
其他：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.

研究衡量的是什么？

主要结果指标

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

次要结果测量

结果测量
措施说明
大体时间
Change in Trail Making Test Part A Completion Time
大体时间：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.
Baseline and Week 4.
Change in Trail Making Test Part B Completion Time
大体时间：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.
Baseline and Week 4.
Change in Montreal Cognitive Assessment Score
大体时间：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.
Baseline and Week 4.
Change in the Digit Symbol Substitution Test Score
大体时间：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.
Baseline and Week 4.
Change in Short Self-Regulation Questionnaire Score
大体时间：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.
Baseline and Week 4.
Change in Stroop Color and Word Test Interference Score
大体时间：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.
Baseline and Week 4.
Change in Stroop Word Score
大体时间：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.
Baseline and Week 4.
Change in Stroop Color Score
大体时间：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.
Baseline and Week 4.
Change in Stroop Color-Word Score
大体时间：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.
Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Total Acquisition Score
大体时间：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.
Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Learning Score
大体时间：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.
Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Proactive Interference Score
大体时间：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.
Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Retroactive Interference Score
大体时间：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.
Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Recognition Score
大体时间：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.
Baseline and Week 4.
Change in Rey Auditory Verbal Learning Test Intrusion Errors
大体时间：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.
Baseline and Week 4.
Change in Resting Systolic Blood Pressure
大体时间：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.
Baseline and Week 4.
Change in Resting Diastolic Blood Pressure
大体时间：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.
Baseline and Week 4.

其他结果措施

结果测量
措施说明
大体时间
Change in Handgrip Maximal Voluntary Contraction
大体时间：Baseline and Week 4.
Maximal voluntary contraction (MVC) will be assessed using a handgrip dynamometer to determine participants' maximal grip strength. MVC for each hand will be determined as the highest force, in kilograms (kg), produced across three trials. MVC will be measured at baseline and post-intervention (4 weeks) to explore changes over time. Prior to each intervention session, participants will complete one MVC trial per hand to calibrate exercise intensity at 30% MVC; these session-level MVC values will be used for exercise prescription only. Higher values indicate greater grip strength.
Baseline and Week 4.
Change in Resting Heart Rate
大体时间：Baseline and Week 4.
Resting heart rate 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. Heart rate will be recorded in beats per minute (bpm), with lower values generally indicating better cardiovascular function.
Baseline and Week 4.
Expectancy of Cognitive Outcome
大体时间：Baseline.
Participant expectancy of cognitive improvement will be assessed at baseline using a single-item 6-item Likert-type scale adapted from prior research, with the response options ranging from "a little improvement" to "extreme improvement." Higher scores indicate greater expectancy of improvement. This measure will be used to explore associations between expectancy and changes in cognitive function.
Baseline.
Post-Exercise Rating of Perceived Exertion (RPE)
大体时间：Over the intervention period, 4 weeks.
Perceived exertion will be assessed immediately following each isometric handgrip contraction during each exercise session using the Borg 6-20 Rating of Perceived Exertion Scale. The scale ranges from 6 to 20, with higher scores indicating greater perceived exertion.
Over the intervention period, 4 weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

McMaster University

调查人员

  • 首席研究员：Jennifer Heisz, PhD、McMaster University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月28日

初级完成 (估计的)

2026年9月15日

研究完成 (估计的)

2026年9月15日

研究注册日期

首次提交

2026年4月21日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 19720

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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