NCT07448818

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
19mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

February 16, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

February 16, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

HypertensionStrength trainingResistance trainingCardiovascular healthblood pressureold age

Outcome Measures

Primary Outcomes (6)

  • 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

Secondary Outcomes (17)

  • 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

  • +12 more secondary outcomes

Study Arms (3)

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.

Behavioral: Dynamic Strength Training

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.

Behavioral: Isometric Strength Training

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.

Behavioral: No supervised intervention Control

Interventions

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.

Dynamic Strength Training

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.

Isometric Strength Training

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

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uninove

São Paulo, São Paulo, 01525-000, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Raphael M Ritti-Dias, PhD

    University of Nove de Julho

    STUDY CHAIR

Central Study Contacts

Adão Luis Monte L Monte, Ms

CONTACT

Raphael M Ritti-Dias, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 16, 2026

First Posted

March 4, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Data will be anonymized and shared after the completion of the study and publication of the main results

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be shared adter the publication of the main trial
Access Criteria
Will be avaliable in open repositories

Locations