About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Dynamic Strength Training
BehavioralThe experimental group will perform dynamic strength exercises targeting major muscle groups, progressing in intensity and volume over the 6 weeks. Exercises include 8 major muscle group movements, initially 2 sets of 15 repetitions (Borg 4-6), progressing to 3 sets of 10 repetitions (Borg 5-7) from week 5. Participants will also be advised to perform non-supervised walking 3-5 times per week for \~30 minutes at moderate intensity.
Isometric Strength Training
BehavioralThe experimental group will perform isometric strength exercises targeting major muscle groups, progressing in intensity and volume over the 6 weeks. Exercises include 8 major muscle group contractions, initially 2 sets of 60 seconds (Borg 4-6), progressing to 3 sets of 40 seconds (Borg 5-7) from week 5. Participants will also be advised to perform non-supervised walking 3-5 times per week for \~30 minutes at moderate intensity.
No supervised intervention Control
BehavioralThis group serves as a control and will not perform any structured exercise program.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment rate
Proportion of enrolled participants relative to the total number of eligible individuals contacted. Reported as a percentage.
Adherence to training sessions
Percentage of completed training sessions relative to the total number of planned sessions over the 6-week intervention period.
Retention rate
Proportion of participants who complete the full 6-week intervention
Fidelity to exercise protocol
Percentage of exercises performed according to the prescribed protocol parameters, including load, repetitions, and time under tension.
Secondary outcomes
Change from baseline in Clinical resting blood pressure at 6 weeks
Systolic and diastolic blood pressure measured with automatic device (HEM-742, Omron Healthcare, Japan) in seated position, average of last two of three readings, in millimeters of mercury.
Change from baseline in Home blood pressure monitoring at 6 weeks
Seven-day home monitoring with automatic device (Omron Healthcare, Japan), two readings morning and evening in duplicate; average of valid readings, in millimeters of mercury
Change from baseline in Flow-mediated dilation at 6 weeks
Brachial and femoral artery vasodilation assessed by ultrasonography with spectral Doppler (Cannon Xario, Japan); calculated as percentage change from baseline
Change from baseline in Standard deviation of normal R-R intervals at 6 weeks
Standard deviation of normal R-R intervals will be assessed using the Polar V800 heart rate monitor (Polar Electro, Finland) and expressed in milliseconds (ms).
Sponsors and contacts
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Raphael Mendes Ritti Dias
Lead sponsor
University of Nove de Julho
Sponsor institution