- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448818
Dynamic and Isometric Strength Training in Older Adults With Hypertension (Dynamic and Is)
April 27, 2026 updated by: Raphael Mendes Ritti Dias
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
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adão Luis Monte L Monte, Ms
- Phone Number: +55 11 94666 5213
- Email: adaoluiz8@outlook.com
Study Contact Backup
- Name: Raphael M Ritti-Dias, PhD
- Phone Number: +5519999406878
- Email: raphaelritti@gmail.com
Study Locations
-
-
São Paulo
-
São Paulo, São Paulo, Brazil, 01525-000
- Recruiting
- Uninove
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dynamic Strength Training
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.
|
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.
|
|
Experimental: Isometric Strength Training
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.
|
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.
|
|
Other: Control
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.
|
This group serves as a control and will not perform any structured exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 6 weeks
|
|
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.
|
During 6 weeks
|
|
Retention rate
Time Frame: During 6 weeks
|
Proportion of participants who complete the full 6-week intervention
|
During 6 weeks
|
|
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.
|
Duiring 6 weeks
|
|
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
|
During 6 weeks
|
|
Occurrence of adverse events
Time Frame: During 6 weeks
|
Number of intervention-related adverse events, classified as mild, moderate, or severe
|
During 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 6 weeks
|
|
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
|
Baseline and 6 weeks
|
|
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
|
Baseline and 6 weeks
|
|
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).
|
Baseline and 6 weeks
|
|
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
|
Baseline and 6 weeks
|
|
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
|
Baseline and 6 weeks
|
|
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
|
Baseline and 6 weeks
|
|
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.
|
Baseline and 6 weeks
|
|
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).
|
Baseline to 6 weeks
|
|
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).
|
Baseline to 6 weeks.
|
|
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.
|
Baseline to 6 weeks.
|
|
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.
|
Baseline to 6 weeks.
|
|
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).
|
Baseline to 6 weeks.
|
|
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.
|
Baseline and 6 weeks.
|
|
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.
|
Baseline and 6 weeks.
|
|
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).
|
Baseline and 6 weeks.
|
|
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).
|
Baseline and 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Raphael M Ritti-Dias, PhD, University of Nove de Julho
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
February 16, 2026
First Submitted That Met QC Criteria
February 26, 2026
First Posted (Actual)
March 4, 2026
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DYNISO-HT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be anonymized and shared after the completion of the study and publication of the main results
IPD Sharing Time Frame
Data will be shared adter the publication of the main trial
IPD Sharing Access Criteria
Will be avaliable in open repositories
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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