NCT05544357

Brief Summary

The main purpose of this project is to analyze the effect of set configuration of resistance exercise on cardiovascular responses and adaptations of postmenopausal women. Additionally, since previous studies have shown that individual´s blood pressure level can influence on the impact of resistance training programs on cardiovascular changes, we aim to contrast acute and chronic changes to resistance training programs in normotensive and hypertensive postmenopausal women.

Trial Health

87
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

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

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

September 10, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 3, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2025

Completed
Last Updated

May 1, 2026

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

September 10, 2022

Last Update Submit

April 27, 2026

Conditions

PostmenopausalHypertension

Keywords

resistance trainingpostmenopausal womencardiovascular responsescardiovascular adaptations

Outcome Measures

Primary Outcomes (8)

  • Baroreflex sensitivity

    Simultaneous electrocardiogram and beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor will be used for calculating baroreflex sensitivity by sequential methods. Units: mmHg/ms

    25 minutes

  • Blood pressure

    Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg

    25 minutes

  • Heart rate variability in time domain

    Standard deviation of the normal-to-normal interval (SDNN) and root of the mean squared differences of successive NN intervals (RMSSD) will be obtained by analyzing inter-beat intervals from electrocardiogram recordings. Units: ms

    25 minutes

  • Heart rate variability in frequency domain

    Obtained from spectral analysis of electrocardiogram recordings. High (HF) and Low (LF) frequency bands power will be determined by Fast Fourier Transformation method. Units: ms2/Hz

    25 minutes

  • Blood pressure variability

    It will be calculated by spectral analysis of beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor. Units: mmHg2/Hz

    25 minutes

  • Resting metabolic rate

    It will be obtained by measuring oxygen consumption at rest. Units: kcal/·day

    60 minutes

  • Arterial stiffness

    It will be assessed by finger-toe pulse wave velocity method. Units: m/s

    15 minutes

  • Bone mineral density

    It will be obtained by a Ultrasound Bone Densitometer. Units: g/cm

    10 minutes

Secondary Outcomes (10)

  • Skeletal muscle mass

    10 minutes

  • Fat mass

    10 minutes

  • Body mass

    10 minutes

  • Body mass index

    2 minutes

  • Height

    10 minutes

  • +5 more secondary outcomes

Study Arms (4)

Resistance training with short set configuration performed by normotensive postmenopausal women

EXPERIMENTAL

Normotensive postmenopausal women performing resistance training protocol with the lowest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol

Other: Short set configuration resistance training

Resistance training with short set configuration performed by hypertensive postmenopausal women

EXPERIMENTAL

Hypertensive postmenopausal women performing resistance training protocol with the lowest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol

Other: Short set configuration resistance training

Resistance training with long set configuration performed by normotensive postmenopausal women

EXPERIMENTAL

Normotensive postmenopausal women performing resistance training protocol with the highest cardiovascular stress identified in the first study of the project. It can be expected to be a long set configuration protocol

Other: Long set configuration resistance training

Resistance training with long set configuration performed by hypertensive postmenopausal women

EXPERIMENTAL

Hypertensive postmenopausal women performing resistance training protocol with the highest cardiovascular stress identified in the first study of the project. It can be expected to be a long set configuration protocol

Other: Long set configuration resistance training

Interventions

Short set configuration resistance trainingOTHER

Resistance training protocol with the lowest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol

Resistance training with short set configuration performed by hypertensive postmenopausal womenResistance training with short set configuration performed by normotensive postmenopausal women
Long set configuration resistance trainingOTHER

Resistance training protocol with the highest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol

Resistance training with long set configuration performed by hypertensive postmenopausal womenResistance training with long set configuration performed by normotensive postmenopausal women

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One year since menopause
  • Physically active (150-300 minutes a week of moderate physical activity or at least 75 minutes a week of vigorous physical activity)
  • No more than 3 cardiovascular risk factors
  • Asymptomatic and without cardiovascular (except hypertension), metabolic or renal disease
  • Hypertensive women should be diagnosed with grade 1 hypertension that must be well controlled by one drug and with low or moderate cardiovascular risk.

You may not qualify if:

  • Having grade 2 or 3 hypertension
  • Participants with hypertension and taking more than one drug for controlling hypertension or by a drug that can interfere cardiovascular responses to exercise
  • To be or have been receiving hormonal replacement therapy
  • To show hypertensive response to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport Sciences and Physical Education

Bastiagueiro, A Coruña, 15179, Spain

Location

Related Publications (4)

  • Iglesias-Soler E, Farinas J, Rua-Alonso M, Rial-Vazquez J, Nine I, Revuelta-Lera B. Shorter Set Configurations Attenuate Performance Loss and Lactatemia During Resistance Training in Postmenopausal Women: A Randomized Crossover Trial (CARE Project). J Strength Cond Res. 2026 Feb 1;40(2):e180-e188. doi: 10.1519/JSC.0000000000005301. Epub 2025 Dec 5.

    PMID: 41369549DERIVED

  • Rial-Vazquez J, Rua-Alonso M, Enriquez-Gonzalez MG, Nine I, Rivera-Mejia SL, Revuelta-Lera B, Farinas J, Iglesias-Soler E. Cardiovascular adaptations to resistance training with different set configurations in postmenopausal women: a study protocol for a randomised controlled trial (CARE project). BMJ Open Sport Exerc Med. 2025 Nov 28;11(4):e003052. doi: 10.1136/bmjsem-2025-003052. eCollection 2025.

    PMID: 41334240DERIVED

  • Nine I, Padron-Cabo A, Carballeira E, Rial-Vazquez J, Rua-Alonso M, Farinas J, Giraldez-Garcia M, Iglesias-Soler E. Acute cardiovascular responses of postmenopausal women to resistance training sessions differing in set configuration: A study protocol for a crossover trial. PLoS One. 2024 Oct 14;19(10):e0311524. doi: 10.1371/journal.pone.0311524. eCollection 2024.

    PMID: 39401188DERIVED

  • Bohn L, Rial-Vazquez J, Nine I, Rua-Alonso M, Farinas J, Giraldez-Garcia MA, Mota J, Iglesias-Soler E. Arterial stiffness assessment by pulse wave velocity in postmenopausal women: comparison between noninvasive devices. Menopause. 2024 Aug 1;31(8):709-715. doi: 10.1097/GME.0000000000002383. Epub 2024 Jun 25.

    PMID: 38916283DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Eliseo Iglesias-Soler, PhD

    University of A Coruna

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 10, 2022

First Posted

September 16, 2022

Study Start

February 3, 2023

Primary Completion

September 26, 2025

Study Completion

September 26, 2025

Last Updated

May 1, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

After finishing the protocols (six months approximately) main data will be shared through European data repository Zenodo, in which University of A Coruna has created a community (https://zenodo.org/communities/udc/?page=1\&size=20\&size=20).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
6 months after finishing the whole project

Locations

ES(1)