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NCT Number: NCT07448818

Dynamic and Isometric Strength Training in Older Adults With Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Elderly (People Aged 65 or More) Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uninove

São Paulo, 01525-000, Brazil

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Dynamic Strength Training

Behavioral

The 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

Behavioral

The 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

Behavioral

This group serves as a control and will not perform any structured exercise program.

Primary outcomes

  1. Recruitment rate

    Time frame: Baseline and 6 weeks

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

  2. Adherence to training sessions

    Time frame: During 6 weeks

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

  3. Retention rate

    Time frame: During 6 weeks

    Proportion of participants who complete the full 6-week intervention

  4. Fidelity to exercise protocol

    Time frame: Duiring 6 weeks

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

  5. Acceptability of the intervention

    Time frame: During 6 weeks

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

  6. Occurrence of adverse events

    Time frame: During 6 weeks

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

Secondary outcomes

  1. Change from baseline in Clinical resting blood pressure at 6 weeks

    Time frame: Baseline and 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.

  2. Change from baseline in Home blood pressure monitoring at 6 weeks

    Time frame: Baseline and 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

  3. Change from baseline in Flow-mediated dilation at 6 weeks

    Time frame: Baseline and 6 weeks

    Brachial and femoral artery vasodilation assessed by ultrasonography with spectral Doppler (Cannon Xario, Japan); calculated as percentage change from baseline

  4. Change from baseline in Standard deviation of normal R-R intervals at 6 weeks

    Time frame: Baseline and 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).

  5. Change from baseline in Arterial stiffness at 6 weeks

    Time frame: Baseline and 6 weeks

    Carotid-femoral pulse wave velocity measured by applanation tonometry (SphygmoCor, AtCor Medical, Australia), calculated as distance/time in meters per second

  6. Change from baseline in Depressive symptoms at 6 weeks

    Time frame: Baseline and 6 weeks

    Geriatric Depression Scale (GDS-15), 15 items, scored 0-15, higher score = worse symptoms

  7. Change from baseline in Anxiety symptoms at 6 weeks

    Time frame: Baseline and 6 weeks

    Generalized Anxiety Disorder questionnaire (GAD-7), 7 items, scored 0-21, higher score = worse symptoms

  8. Change from baseline in Six-Minute Walk Test distance at 6 weeks

    Time frame: Baseline and 6 weeks

    Distance walked in meters during the six-minute walk test performed in a 30-meter corridor.

  9. Change from baseline in Root mean square of successive differences between R-R intervals at 6 weeks

    Time frame: Baseline to 6 weeks

    Root mean square of successive differences between R-R intervals will be measured using the Polar V800 heart rate monitor (Polar Electro, Finland) and expressed in milliseconds (ms).

  10. Change from baseline in Proportion of successive R-R intervals differing by more than 50 milliseconds at 6 weeks

    Time frame: Baseline to 6 weeks.

    Proportion of successive R-R intervals differing by more than 50 milliseconds will be measured using the Polar V800 heart rate monitor (Polar Electro, Finland) and expressed in milliseconds (ms).

  11. Change from baseline in Low-frequency spectral power at 6 weeks

    Time frame: Baseline to 6 weeks.

    Low-frequency spectral power will be assessed using the Polar V800 (Polar Electro, Finland) and expressed in ms².

  12. Change from baseline in high-frequency power at 6 weeks

    Time frame: Baseline to 6 weeks.

    high-frequency power High-frequency component measured with Polar V800 (Polar Electro, Finland), expressed in ms².

  13. Change from baseline in Low-frequency to high-frequency ratio at 6 weeks

    Time frame: Baseline to 6 weeks.

    Low-frequency to high-frequency ratio measured with Polar V800 (Polar Electro, Finland).

  14. Change from baseline in Timed Up and Go Time at 6 weeks

    Time frame: Baseline and 6 weeks.

    time in seconds to stand from a chair, walk 3 meters, turn, return, and sit down.

  15. Change from baseline in 30-second Chair stand repetitions at 6 weeks

    Time frame: Baseline and 6 weeks.

    number of full stands from a seated position completed in 30seconds.

  16. Change from baseline in handgrip strength at 6 weeks

    Time frame: Baseline and 6 weeks.

    maximum voluntary isometric handgrip strength measured using handheld dynamometer instrutherm DM-90 (Brazil), expressed in kilogram-force (kgf).

  17. Change from baseline in isometric knee extensor strength at 6 weeks

    Time frame: Baseline and 6 weeks.

    Maximum isometric knee extensor strength measured at 90º knee angle using horizontal leg press, expressed in kilogram-force (kgf).

Study contacts

Contact information is provided by the study sponsor or research team.

Adão Luis Monte L Monte, Ms

CONTACT

[email protected]

+55 11 94666 5213

Raphael M Ritti-Dias, PhD

CONTACT

[email protected]

+5519999406878

Sponsors and collaborators

Lead sponsor

Raphael Mendes Ritti Dias

Other

Registry information

Official study title

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

Acronym: Dynamic and Is

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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