NCT04218903

Brief Summary

Combined training is a cornerstone intervention to improve functionality and to reduce blood pressure in older adults with hypertension. Acute blood pressure lowering after exercise seems to predict the extent of blood pressure reduction after chronic training interventions. Based on that, the same weekly amount of exercise performed more frequently could be more beneficial to blood pressure management. The aim of the present study is to evaluate the effects of a combined exercise program performed four versus two times per week on 24-h ambulatory blood pressure and other cardiovascular risk factors in older individuals with hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

January 3, 2020

Last Update Submit

April 22, 2025

Conditions

Keywords

AgingAmbulatory Blood Pressure MonitoringConcurrent TrainingDose-response

Outcome Measures

Primary Outcomes (1)

  • Ambulatory Blood Pressure

    24h ambulatory blood pressure measured through automatic oscillometric device

    Change from baseline 24-hour systolic blood pressure at 12 weeks

Secondary Outcomes (6)

  • Systolic blood pressure

    Change from baseline office blood pressure at 12 weeks

  • Diastolic blood pressure

    Change from baseline office blood pressure at 12 weeks

  • Cardiorespiratory fitness

    Change from baseline VO2peak at 12 weeks

  • Upper limbs muscle strength

    Change from baseline handgrip test at 12 weeks

  • Lower limbs muscle strength

    Change from baseline sitting-rising test at 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Combined Training 4 times per week (CT4)

EXPERIMENTAL

The CT4 group will perform four sessions per week of combined exercise program. This intervention will last 12 weeks.

Behavioral: Combined training performed four times per week (CT4)

Combined Training 2 times per week (CT2)

ACTIVE COMPARATOR

The CT2 group will perform two sessions per week of combined exercise program. This intervention will last 12 weeks.

Behavioral: Combined training performed two times per week (CT2)

Interventions

CT4 will perform four combined training sessions per week throughout 12 weeks. Each session will be composed 10-15 minutes of resistance exercise (1-4 sets of 10-15 repetitions, using an intensity corresponding to 50-70%1RM in 3 exercises) followed by 20-25 minutes of aerobic exercise (walking or running at an intensity corresponding to 60-70% of VO2peak).

Combined Training 4 times per week (CT4)

CT2 will perform two combined training sessions per week throughout 12 weeks. Each session will be composed 20-30 minutes of resistance exercise (1-4 sets of 10-15 repetitions, using an intensity corresponding to 50-70%1RM in 6 exercises) followed by 40-50 minutes of aerobic exercise (walking or running at an intensity corresponding to 60-70% of VO2peak).

Combined Training 2 times per week (CT2)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood pressure, respectively or taking at least one antihypertensive medication
  • Not engaged in structured exercise programs (3 or more times per week) in the last 3 months before the study

You may not qualify if:

  • Physical and muscular injuries that limit to accomplishment of the different training proposed in the study
  • Underlying cardiovascular disease in the last 24 months such as acute myocardial infarction, angina, stroke or heart failure
  • Health conditions that limit physical exercise perform, such as lung disease, valvar heart disease, renal failure
  • Diseases that reduce life expectancy
  • BMI \> 39.9 kg/m²
  • Diabetic proliferative retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Interventions

CD5L protein, human

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Rodrigo Ferrari, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 6, 2020

Study Start

March 1, 2022

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Locations