跳至主要内容
临床试验/NCT07448818
NCT07448818招募中不适用

Effects of Dynamic Strength Training and Isometric Strength Training on Cardiovascular Health Indicators, Mental Health, and Neuromuscular Fitness in Older Adults With Hypertension: A Feasibility Study

Raphael Mendes Ritti Dias1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Recruitment rate

研究概览

简要总结

This feasibility study aims to evaluate the effects of dynamic strength training and isometric strength training on cardiovascular health indicators, mental health, and neuromuscular fitness in older adults with hypertension. Participants will be randomly assigned to one of the two training modalities and will complete supervised exercise sessions throughout the intervention period. The study will provide preliminary evidence regarding the safety, acceptability, and potential impact of each training modality on health outcomes in this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of arterial hypertension and currently taking antihypertensive medication
  • Age 60 years or older
  • Resting blood pressure below 160/95 mmHg
  • No high cardiovascular risk according to the American College of Sports Medicine criteria (for participants with type 2 diabetes, glycemic control with fasting glucose <100 mg/dL and postprandial glucose <140 mg/dL)
  • Not participating in a structured exercise program for more than three months
  • No cognitive or functional limitations that prevent participation in the exercise program

排除标准

  • Presence of acute illnesses, such as influenza, sinusitis, gastroenteritis, urinary tract infection, fever, inflammatory processes, or any clinical condition requiring rest or that may compromise safety during assessments or training.
  • Decompensated clinical conditions, including: Blood pressure spikes, Chest pain, Uncontrolled arrhythmias, Shortness of breath at rest, Asthma exacerbations, Decompensated diabetes mellitus, characterized by Persistently elevated blood glucose levels (fasting glucose > 180 mg/dL or postprandial glucose > 250 mg/dL)
  • Irregular use of medication
  • Any unstable clinical condition or condition that represents additional risk for the practice of physical exercise.

研究组 & 干预措施

Dynamic Strength Training

Active Comparator

The subjects randomized to this group will perform two supervised dynamic strength training sessions per week for 6 weeks, each session lasting approximately 30 minutes.

干预措施: Dynamic Strength Training (Behavioral)

Isometric Strength Training

Experimental

The subjects randomized to this group will perform two supervised isometric strength training sessions per week for 6 weeks, each session lasting approximately 30 minutes.

干预措施: Isometric Strength Training (Behavioral)

Control

Other

No supervised training will be provided. Participants in this group will not receive any exercise intervention during the 6-week study period, but they will be stimulated to be active.

干预措施: No supervised intervention Control (Behavioral)

结局指标

主要结局

Recruitment rate

时间窗: Baseline and 6 weeks

Proportion of enrolled participants relative to the total number of eligible individuals contacted. Reported as a percentage.

Adherence to training sessions

时间窗: During 6 weeks

Percentage of completed training sessions relative to the total number of planned sessions over the 6-week intervention period.

Retention rate

时间窗: During 6 weeks

Proportion of participants who complete the full 6-week intervention

Fidelity to exercise protocol

时间窗: Duiring 6 weeks

Percentage of exercises performed according to the prescribed protocol parameters, including load, repetitions, and time under tension.

Acceptability of the intervention

时间窗: During 6 weeks

Acceptability assessed through a structured satisfaction questionnaire, scored from 0 to 10, administered at the end of the 6-week intervention

Occurrence of adverse events

时间窗: During 6 weeks

Number of intervention-related adverse events, classified as mild, moderate, or severe

次要结局

  • Change from baseline in Clinical resting blood pressure at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Home blood pressure monitoring at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Flow-mediated dilation at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Standard deviation of normal R-R intervals at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Arterial stiffness at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Depressive symptoms at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Anxiety symptoms at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Six-Minute Walk Test distance at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Root mean square of successive differences between R-R intervals at 6 weeks(Baseline to 6 weeks)
  • Change from baseline in Proportion of successive R-R intervals differing by more than 50 milliseconds at 6 weeks(Baseline to 6 weeks.)
  • Change from baseline in Low-frequency spectral power at 6 weeks(Baseline to 6 weeks.)
  • Change from baseline in high-frequency power at 6 weeks(Baseline to 6 weeks.)
  • Change from baseline in Low-frequency to high-frequency ratio at 6 weeks(Baseline to 6 weeks.)
  • Change from baseline in Timed Up and Go Time at 6 weeks(Baseline and 6 weeks.)
  • Change from baseline in 30-second Chair stand repetitions at 6 weeks(Baseline and 6 weeks.)
  • Change from baseline in handgrip strength at 6 weeks(Baseline and 6 weeks.)
  • Change from baseline in isometric knee extensor strength at 6 weeks(Baseline and 6 weeks.)

研究者

发起方
Raphael Mendes Ritti Dias
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Raphael Mendes Ritti Dias

PhD

University of Nove de Julho

研究点 (1)

Loading locations...

相似试验