NCT06845514

Brief Summary

The goal of the clinical trial is to understand the effect of two resistance training protocols employing different loading intensities (% of 1 repetition maximum; 1-RM), but with standardized effort intensity (2 repetitions in reserve; RIR) on post-exercise and ambulatory blood pressure in aging females. The main questions it aims to answer are:

  • to examine the acute effects of low (50% 1-RM) and high (80% 1-RM) load intensity resistance exercise with a standardized high effort intensity on post-exercise hypotension and ambulatory blood pressure responses in aging females;
  • deepen the understanding of the mechanisms underlying acute reductions in blood pressure in response to resistance exercise performed at different load intensities. To this end, autonomic activity will be estimated alongside the measurement of central arterial compliance (i.e., carotid artery), and serum biomarkers of endothelial function;
  • document the affective valence and enjoyment associated with low (50% 1-RM) and high (80% 1-RM) load intensity resistance exercise when performed at a high perceived effort. Researchers will compare the effect of: 1) a low load (LL-RE) intensity protocol consisting of 3 sets of each exercise at 50% 1-RM, performed until reaching a hard perceived effort intensity (i.e., RIR-2); 2) high load (HL-RE) intensity protocol consisting of 3 sets of each exercise at 80% of 1-RM, performed until reaching a hard perceived effort intensity (i.e., RIR-2); 3) and a control condition (CON) consisting of a standardized non-fatiguing cognitive task. Participants will participate in:
  • A preliminary assessment visit;
  • Two familiarization visits to validate the exercise prescriptions;
  • Three experimental visits (CON, LL-RE, HL-RE).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Jul 2025

Longer than P75 for not_applicable

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 Progress24%
Jul 2025Dec 2028

First Submitted

Initial submission to the registry

February 12, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 8, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 9, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

February 12, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

resistance trainingambulatory blood pressureaging femalesload intensityperceived effort

Outcome Measures

Primary Outcomes (2)

  • Change in blood pressure post-exercise

    Oscillometric blood pressure monitor

    Before the start of the condition (t = 0 minute), at the end of the condition (t = 60 minutes), each 20 min for 1 hour post-condition (t = 80, 100, 120 minutes)

  • Change in ambulatory blood pressure

    Ambulatory blood pressure monitor

    During 24 hours after the condition

Secondary Outcomes (10)

  • Heart rate variability

    Before the start of the condition (t = 0 minute), at the end of the condition (t = 60 minutes), each 20 min for 1 hour post-condition (t = 80, 100, 120 minutes), during 24 hours after the condition

  • Carotid artery diameter as assessed by Cardiovascular Suite v4.6.1

    Before the start of the condition (t = 0 minute), at the end of the condition (t = 60 minutes), 1 hour post-condition (t = 120 minutes)

  • Carotid artery distensibility as assessed by Cardiovascular Suite v4.6.1

    Before the start of the condition (t = 0 minute), at the end of the condition (t = 60 minutes), 1 hour post-condition (t = 120 minutes)

  • Carotid artery blood flow velocity

    Before the start of the condition (t = 0 minute), at the end of the condition (t = 60 minutes), 1 hour post-condition (t = 120 minutes)

  • Serum endothelin-1

    Before the start of the condition (t = 0 minute), at the end of the condition (t = 60 minutes), 1 hour post-condition (t = 120 minutes)

  • +5 more secondary outcomes

Other Outcomes (6)

  • Velocity loss in concentric contraction speed

    Continuously during the condition (t = 0 minute to t = 60 minutes)

  • Hematocrit/hemoglobin concentration

    At the end of the condition (t = 60 minutes)

  • Estimated daily energy expenditure

    During 24 hours after the condition

  • +3 more other outcomes

Study Arms (3)

Condition LL-RE

EXPERIMENTAL

Low-load resistance exercise

Other: Condition LL-RE

Condition HL-RE

EXPERIMENTAL

High-load resistance exercise

Other: Condition HL-RE

Condition CON

SHAM COMPARATOR

Control condition

Other: Control

Interventions

LL-RE condition will consist of a 5-minute warm-up (slow-paced walking) and the following exercises: leg press, chest press, leg curl, and seated row. Three sets will be performed for each exercise with a 3-minute rest period between sets/exercises. Each exercise will be executed through a full range of motion, with participants encouraged to follow a 2-sec eccentric phase (guided by a mobile app metronome and supervised by an exercise physiologist) and to perform the concentric phase as fast as possible. Participants will be informed to: stop the set when they perceive to have reached the RIR target. • LL-RE: The low load intensity protocol consists of 3 sets of each exercise at 50% 1-RM, performed until reaching a hard perceived effort intensity (i.e., RIR-2).

Condition LL-RE
ControlOTHER

Control condition: During the control condition, participants will sit quietly in a room maintained at a temperature of 22-24°C to prevent any influence on blood pressure values, for 60 minutes. During this period, they will perform a standardized non-fatiguing cognitive task: watching Earth, a documentary following the migration paths of four animal families.

Condition CON

HL-RE condition will consist of a 5-minute warm-up (slow-paced walking) and the following exercises: leg press, chest press, leg curl, and seated row. Three sets will be performed for each exercise with a 3-minute rest period between sets/exercises. Each exercise will be executed through a full range of motion, with participants encouraged to follow a 2-sec eccentric phase (guided by a mobile app metronome and supervised by an exercise physiologist) and to perform the concentric phase as fast as possible. Participants will be informed to: stop the set when they perceive to have reached the RIR target. • HL-RE: The high load intensity protocol consists of 3 sets of each exercise at 80% of 1-RM, performed until reaching a hard perceived effort intensity (i.e., RIR-2).

Condition HL-RE

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIn the case of initiation of a gender-affirming therapy known to influence blood pressure.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 50 to 70 years;
  • absence of menstruation for 12 consecutive months;
  • normal-high resting blood pressure (120 ≤ Systolic ≤ 139 mmHg and 80 ≤ Diastolic ≤ 89 mmHg) or stage 1 hypertension (140 ≤ Systolic ≤ 159 mmHg or 90 \< Diastolic ≤ 99 mmHg);
  • physically inactive (\< 150 minutes of structured aerobic physical activity per week);
  • and not engaging in regular resistance exercise (≥ 2 sessions per week) for more than 3 months during the year.

You may not qualify if:

  • orthopedic limitations or other contraindications to resistance exercise;
  • scheduled surgery during the study;
  • unstable hypertension (≥ 160/100 mmHg);
  • diagnosis of type 2 diabetes;
  • cardiovascular event in the past 6 months or sequelae preventing exercise;
  • and initiation of hormonal replacement therapy (\< 4 months) known to affect blood pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center on Aging

Sherbrooke, Quebec, J1H 2J7, Canada

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Eléonor Riesco, Ph.D.

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eléonor Riesco, Ph.D.

CONTACT

Renaud Tremblay, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Each participant will perform 3 experimental conditions (control condition; low-load resistance exercise; high-load resistance exercise).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 25, 2025

Study Start

July 8, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 9, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations