NCT06758206

Brief Summary

There are easily accessible and safe strategies, such as resistance training, that can contribute to reducing depressive symptoms and preserving physical and executive function in older women. Resistance training is defined as exercises performed either in water or on land, involving the use of a constant load or uniform weight, regardless of the training program. Various types of resistance training equipment are available, including free weights, pneumatic resistance machines, elastic bands, or even body weight. Specifically, eccentric muscle action occurs when the force applied to the muscle exceeds the momentary force produced by the muscle itself, resulting in the forced elongation of the muscle-tendon system during contraction. To date, evidence from randomized clinical trials has compared the effectiveness of aerobic, resistance, and Pilates exercises in reducing depressive symptoms and improving physical and executive function in older women. While experimental studies have demonstrated the efficacy of physical exercise, the effect of long-term eccentrically reinforced resistance training on depressive symptoms, physical function, and executive function in sedentary older women remains unclear. Therefore, this study aims to evaluate the safety and effect of eccentrically reinforced resistance exercise versus traditional resistance training on depressive symptoms, physical and executive function, quality of life, different manifestations of muscle strength, body composition, vital signs, abdominal circumference, fall risk, and fatigue symptoms in sedentary older women over a 10-month period.

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 2025

Geographic Reach
1 country

2 active sites

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

December 22, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 22, 2024

Last Update Submit

January 21, 2026

Conditions

Keywords

depressive symptomsPhysical FunctionExecutive functionResistance trainingEccentric actionOlder women

Outcome Measures

Primary Outcomes (11)

  • Changes in baseline depressive symptoms at ten months.

    Test: The depressive state will be evaluated with a short version of the validated geriatric depression scale (GDS) in Brazil. There are 15 questions that inquire about feelings and a frequency that the person presents before certain conditions of life. These questions require categorical answers (yes or no). Of the 15 items, 10 indicate the presence of depression when answered positively. While the rest (1, 5, 7, 11 and 13) when answered negatively. A higher score indicates depression.

    Baseline, 5 and 10 months

  • Change in baseline test Time up and go at ten months.

    Test: The time up and go will assess sitting balance, balance in transfers from sitting to standing, stability in ambulation and changes of direction. The test consists of the individual getting up from the chair, without arm support, walking 3 meters with safe and comfortable steps, without running, turning 180°, returning and sitting in the chair. The time taken to perform this task will be timed. Volunteers who perform the task in a time of less than 10 seconds will be considered with satisfactory mobility, for those who perform the test between 11 and 20 seconds will be classified with good mobility and for those who reach values greater than 20 seconds will be classified with mobility problems.

    Baseline, 5 and 10 months

  • Change in baseline 30-s chair stand at ten months

    There will be a 30-s chair stand for the Senior Fitness Test (SFT), which is a battery of functional tests designed to assess the physical capacity needed for independence in older adults. This test assesses the number of repetitions an individual can lift from a chair in 30 seconds and evaluates leg strength. The more repetitions, the better the functionality.

    Baseline, 5 and 10 months

  • Change in baseline 30-s arm curl at ten months

    The 30-s arm curl of the Senior Fitness Test (SFT) will be performed, which is a battery of functional tests designed to assess the physical capacity required for independence in older adults. This test evaluates the number of repetitions of bicep curls in 30 seconds with a weight of two kilos. It assesses arm strength. The more repetitions, the better the functionality.

    Baseline, 5 and 10 months

  • Change in baseline 6-min walk at ten months

    The 6-min walk test will be carried out, which measures the distance covered in 6 minutes and assesses cardiovascular capacity. It is part of the Senior Fitness Test. The greater the distance covered, the better the functionality.

    Baseline, 5 and 10 months

  • Change in baseline chair sit-and-reach at ten months

    The chair sit-and-reach test will be carried out, which measures the distance between the toes and the tip of the foot on an outstretched leg. It is part of the Senior Fitness Test. The shorter the distance between the limbs, the better the functionality.

    Baseline, 5 and 10 months

  • Change in baseline back scratch at ten months

    The back scratch test will be carried out, which measures the distance between the middle fingers when reaching behind the back with both hands. It is part of the Senior Fitness Test. The shorter the distance between the limbs, the better the functionality.

    Baseline, 5 and 10 months

  • Change in baseline 8-foot up-and-go at ten months

    The 8-foot up-and-go test will be carried out, which measures the time it takes to get up from a chair, walk 8 feet (2.4 m), turn around and return to the chair. It is part of the Senior Fitness Test. The shorter the time taken to complete the course, the better the functionality.

    Baseline, 5 and 10 months

  • Change in Inhibitory control at ten months

    Test: Victoria Stroop test. Inhibitory control will be evaluated using the Victoria Stroop Test, which uses three tasks with 24 items each. The participant is evaluated according to how quickly she performs the task and the number of errors. The effect of interference is determined by calculating the extra time required to name the colors (of the printout) compared to the time required to name colors in the first control task (colors of the cards). The task performed faster indicates better performance.

    Baseline, 5 and 10 months

  • Change in Working memory at ten months

    Working memory will be evaluated by Digit Span Forward and Backward. For the calculation of the test, the sum of the longest sequence of digits repeated, without error, over two trials in direct order is used.

    Baseline, 5 and 10 months

  • Change in Cognitive flexibility at ten months

    Test composed of two parts (Tracks A and Tracks B). The execution time for each of the tests is limited to four minutes or three errors The test score will be obtained through the time spent to finish each part. For speed adjustment, the difference between the completion times of part B and part A will be calculated, in which smaller differences in scores indicate better speed adjustments.

    Baseline, 5 and 10 months

Secondary Outcomes (16)

  • Change in baseline quality of life time at ten months.

    Baseline, 5 and 10 months

  • Maximum isometric voluntary contraction

    Baseline, 5 and 10 months

  • 1RM test

    Baseline, 5 and 10 months

  • Muscle power

    Baseline, 5 and 10 months

  • Change In Baseline Total body mass at ten months

    Baseline, 5 and 10 months

  • +11 more secondary outcomes

Study Arms (2)

Flywheel resistance training

EXPERIMENTAL

Flywheel resistance training will use the isoinertial multi-leg machine for lower and upper limbs for women.

Behavioral: Flywheel Resistance Training

Traditional resistance training

ACTIVE COMPARATOR

Traditional resistance training will use machines for the lower limbs and free weights for the upper limbs.

Behavioral: Traditional resistance training

Interventions

For each training session, 6 to 7 generic exercises will be performed, involving small and large muscle groups (leg extension, leg flexion, biceps curl, triceps extension, seated row, shoulder flexion and shoulder raise). They will perform 4 sets of 8 repetitions, with a 2-minute break between exercises and sets. They will perform these exercises at a high intensity (always 10 on the OMNI-RES Scale).

Flywheel resistance training

For each training session, 6 to 7 generic exercises will be performed, involving small and large muscle groups (leg extension, leg flexion, biceps curl, triceps extension, seated row, shoulder flexion and shoulder raise). They will perform 4 sets of 8 to 12 repetitions, with a 2-minute break between exercises and sets. They will perform these exercises at moderate and high intensities (6 to 10 on the OMNI-RES scale).

Traditional resistance training

Eligibility Criteria

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

You may qualify if:

  • years or older.
  • Self-reported proficiency in speaking, writing, and understanding Portuguese.
  • Willingness and availability to participate in all trial procedures.
  • Good vision in at least one eye.
  • Absence of any medical contraindications for engaging in physical exercise.
  • Engage in less than 150 minutes of physical activity per week.
  • Not clinical diagnosis of major depressive disorder at the time of the interventions.

You may not qualify if:

  • Have uncontrolled chronic or psychiatric illnesses.
  • Surgical procedures scheduled during the intervention period.
  • Diagnosis of joint diseases such as osteoarthritis and arthrosis.
  • Participating in aerobic or resistance exercise programs twice a week for the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidade Federal de Viçosa

Viçosa, Minas Gerais, 36570-900, Brazil

Location

Federal University of Viçosa, Viçosa - Minas Gerais

Viçosa, Minas Gerais, 36570000, Brazil

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Osvaldo Costa Moreira

    Federal University Of Viçosa

    STUDY DIRECTOR
  • Edison A Pérez Bedoya

    Antioquia University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Hidden and opaque envelope technique
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Student in Physical Education, Principal Investigator

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 3, 2025

Study Start

March 10, 2025

Primary Completion

December 19, 2025

Study Completion

January 21, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations