NCT06160141

Brief Summary

Purpose: This study aimed to determine the effect of 48 weeks of resistance training (RT) on cardiac function in older women. Methods: Sixty-four older women (≥ 60 years), physically independent, were selected for this study. Participants were randomized into a training group (TG, n = 33) and a control group (CG, n = 31). The RT program was conducted over 48 weeks, three sessions a week, on nonconsecutive days, in the morning hours. Participants performed eight exercises for the whole body (chest press, horizontal leg press, seated row, leg extension, triceps pushdown, lying leg curl, preacher curl, seated calf raise) in three sets of 8-12 repetitions. The echocardiography was performed according to current guidelines before and after 48 weeks by an experienced echocardiographer blinded to patient status and group assignment. One-repetition maximum (1-RM) tests were used to analyze muscular strength. Glusoce, lipid profile, and C-reactive protein were measured. DEXA was used to measure body fat and muscle mass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

November 9, 2023

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Doppler-echocardiography

    Echocardiography exams were performed according to current guidelines, at baseline and the end of the study, by an experienced echocardiographer blinded to patient status and group. According to current recommendations, cardiac chamber dimensions, volumes, and left ventricular mass were measured. Mitral inflow velocities were assessed using pulsed-wave Doppler in the apical four-chamber view, with the sample volume placed between the tips of the mitral leaflets; velocities were recorded at end-expiration. Tissue Doppler velocities were acquired at end-expiration, in the apical four-chamber view, with the sample positioned at the septal and lateral mitral annulus for determination of systolic (S'), early diastolic (E'), and late diastolic (A') velocities. Pulsed wave Doppler velocities at the upper right pulmonary vein were also recorded. For all parameters, the average of three consecutive heartbeats was recorded.

    48 weeks

Secondary Outcomes (13)

  • Dietary intake

    48 weeks

  • Muscular strength

    48 weeks

  • Body composition

    48 weeks

  • Gait speed test

    48 weeks

  • walking agility test

    48 weeks

  • +8 more secondary outcomes

Study Arms (2)

Training group

EXPERIMENTAL

The training group performed 48 weeks of resistance training, 3 times per week.

Other: Resistance training

Control Group

NO INTERVENTION

The control group did not performed any kind of resistance exercises.

Interventions

Resistance training program. The RT program was performed over 48 weeks, three times per week (Mondays, Wednesdays, and Fridays), during the morning, in the University fitness facility. Participants were personally supervised by Physical Education professionals (1-2 supervisors per exercise) with substantial RT experience to ensure consistent and safe exercise performance. Participants performed four exercises for the trunk and upper limbs and four exercises for the lower limbs in three sets of 8-12 repetitions. T Rest intervals were 1-2 and 2-3 min between sets and exercises. The training load was individually adjusted for each exercise weekly, according to the number of repetitions performed during the last training session, to ensure that the subjects kept performing at the ideal intensity for the repetition zone. In these situations, training loads were increased by 2-5% for upper-limb exercises and 5-10% for lower-limb exercises.

Training group

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • females aged ≥ 60 years; physically independent; had no cardiac, orthopedic, or musculoskeletal dysfunction that could impede physical exercise; not having uncontrolled diabetes mellitus or hypertension; and not be involved in the practice of regular physical activity performed more than once a week over the three months before the start of the study

You may not qualify if:

  • Not completed at least 80% of the sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual de Londrina

Londrina, Paraná, 86.057-970, Brazil

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessor was blind to the primary outcome
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Training groups vs. Control Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 9, 2023

First Posted

December 7, 2023

Study Start

March 1, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

December 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations