NCT06591325

Brief Summary

Background: the purporse was to evaluate and compare the effects of 12 weeks of resistance training (RT) on cardiovascular disease (CVD) risk factors in older women with and without depressive disorders Methods: We included 79 older women, 52 without depressive disorders and 27 with a diagnosis of depressive disorders. The 79 participants passed through 12 weeks of control condition and were instructed to maintain their habitual routine. After the control period, the participants were reevaluated and attended 12 weeks of RT. The Beck Anxiety Inventory (BAI) and Patient Health Questionnaire-9 (PHQ-9) were used to measure anxiety and depressive symptoms, respectively. The serum levels of high-sensitivity C-reactive protein, glucose, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-c), low-density cholesterol (LDL-c), and triglycerides (TG) were used as cardiovascular risk factors. The Linear Mixed Model (LMM) was used to compare between groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 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

November 2, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

September 4, 2024

Last Update Submit

September 7, 2024

Conditions

Keywords

strength trainingdepressive symptomsanxiety symptomscardiovascular risk factor

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular risk factors

    Blood sample (venous) was collected in a tube containing a dipotassium ethylenediaminetetraacetic acid (12 ml, vacuum-sealed system; Vacutainer, England) between 7:00 and 9:00 a.m. by a trained laboratory technician after an overnight fast of at least 12 h. Participants rested in a seated position for at least five minutes before withdrawing 5 ml of blood from a prominent superficial vein in the antecubital space. All samples were centrifuged at 3,000 rpm for 15 min, and plasma or serum aliquots were stored at -80° C until assayed. As determined in human plasma, inter- and intra-assay coefficients of variation were \< 10%.

    From begining to the end 12 weeks

Study Arms (2)

exercise group = participants performed 12 weeks of strength training

EXPERIMENTAL
Other: exerciseOther: Control

control group = participants maintained their usual activities normally

NO INTERVENTION

Interventions

The RT program was performed in the morning and in groups, three days per week (Mondays, Wednesdays, and Fridays), in the University fitness facility over 12 weeks. Participants were personally supervised by Physical Education professionals (1-2 supervisors per exercise session) with substantial RT experience to ensure consistent and safe exercise performance. Throughout the intervention period, the RT program was carried out on machines and free weights (Ipiranga Fitness, Presidente Prudente, SP, Brazil). The training program was carried out in groups. Participants performed four exercises for the trunk and upper limbs (chest press, seated row, triceps pushdown, preacher curl) and four exercises for the lower limbs (horizontal leg press, leg extension, lying leg curl, seated calf raise) in three sets of 10-15 repetitions based on previous guidelines (9,22).

exercise group = participants performed 12 weeks of strength training
ControlOTHER

maintaining the daily routine

exercise group = participants performed 12 weeks of strength training

Eligibility Criteria

Age60 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
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;
  • 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;
  • present the medical clearance from a cardiologist (resting 12-lead electrocardiogram test, personal interview, and treadmill stress test when deemed necessary) to attend RT without restriction.

You may not qualify if:

  • not reaching 85% of training sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Londrina

Londrina, Paraná, 86057-970, Brazil

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

November 2, 2021

Primary Completion

July 25, 2022

Study Completion

July 25, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations