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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | 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 | Percentage of completed training sessions relative to the total number of planned sessions over the 6-week intervention period. | During 6 weeks |
| Retention rate | Proportion of participants who complete the full 6-week intervention | During 6 weeks |
| Fidelity to exercise protocol | Percentage of exercises performed according to the prescribed protocol parameters, including load, repetitions, and time under tension. | Duiring 6 weeks |
| Acceptability of the intervention | 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 | Number of intervention-related adverse events, classified as mild, moderate, or severe | During 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 weeks |
| Change from baseline in Home blood pressure monitoring at 6 weeks |
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Inclusion criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adão Luis Monte L Monte, Ms | Contact | +55 11 94666 5213 | adaoluiz8@outlook.com | |
| Raphael M Ritti-Dias, PhD | Contact | +5519999406878 | raphaelritti@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Raphael M Ritti-Dias, PhD | University of Nove de Julho | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uninove | Recruiting | São Paulo | São Paulo | 01525-000 | Brazil |
Data will be anonymized and shared after the completion of the study and publication of the main results
Data will be shared adter the publication of the main trial
Will be avaliable in open repositories
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | number of full stands from a seated position completed in 30seconds. | Baseline and 6 weeks. |
| Change from baseline in handgrip strength at 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 | Maximum isometric knee extensor strength measured at 90º knee angle using horizontal leg press, expressed in kilogram-force (kgf). | Baseline and 6 weeks. |