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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Канада · 2 центра

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

Идентификаторы

NCT: NCT07648498 · 19720

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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