NCT05910632

Brief Summary

There are easily accessible and safe strategies, such as physical exercise, that can contribute to reducing depressive symptoms and to the preservation of physical and executive function in elderly women. Resistance exercise is defined as performing in water or on land. It involves exercise using a constant load or a uniform weight regardless of the training program. There are many types of resistance exercise equipment, including free weights, pneumatic resistance machines, and elastic bands. Specifically, eccentric muscle contraction occurs when the force applied to the muscle exceeds the momentary force produced by the muscle itself, resulting in forced lengthening of the muscle-tendon system while contracting. To date, a body of evidence has been found derived from randomized controlled trials, which have compared the effectiveness of aerobic, resistance exercise and Pilates in decreasing depressive symptoms and improving physical and executive function in elderly women. Although there are experimental studies demonstrating the effectiveness of physical exercise, the effect of short-term eccentrically reinforced strength training on depressive symptoms, physical and executive function in sedentary older women is unclear. Therefore, this study aims to evaluate the safety and effect of eccentrically reinforced resistance exercise vs. traditional resistance training on depressive symptoms, physical and executive function, quality of life, different manifestations of muscle strength, body composition, vital signs and abdominal circumference, risk of falls, quality of sleep sedentary older women for 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable depression

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

Study Start

First participant enrolled

May 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

May 15, 2023

Last Update Submit

January 25, 2024

Conditions

Keywords

DepressionPhysical FunctionExecutive Function

Outcome Measures

Primary Outcomes (6)

  • Changes in baseline depressive symptoms at two 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 and 8-weeks

  • Change in baseline test Time up and go at two 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 and 8-weeks

  • Change in baseline balance test, mark speed, and sit and stand chair at two months

    The Short Physical Performance Battery (SPPB) in its Brazilian version will be performed, which includes the tests for standing static balance, gait speed, and lower limb muscle strength. The total score of the SPPB will be obtained by adding the score of each test, ranging from zero (worst capacity) to 12 (best capacity). The result can be graded as follows: 0 to 3 points: disability or poor capacity; 4 to 6 points: low capacity; 7 to 9 points: moderate capacity; and 10 to 12 points: good capacity.

    Baseline and 8-weeks

  • Change in Inhibitory control at two 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 and 8-weeks

  • Change in Working memory at two 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 and 8-weeks

  • Change in Cognitive flexibility at two 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 and 8-weeks

Secondary Outcomes (22)

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

    Baseline and 8-weeks

  • Maximum isometric voluntary contraction

    Baseline and 8-weeks

  • 1RM test

    Baseline and 8-weeks

  • Muscle power

    Baseline and 8-weeks

  • Change In Baseline Total body mass at two months

    Baseline and 8-weeks

  • +17 more secondary outcomes

Study Arms (2)

Eccentrically strengthened resistance exercise

EXPERIMENTAL

Women who will be part of the eccentrically reinforced resistance group will perform using the multi-gym equipment with flywheel. Each workout will involve upper and lower extremities.

Behavioral: Eccentrically strengthened resistance exercise

Traditional resistance training

ACTIVE COMPARATOR

The control group (traditional resistance program) will carry out their interventions on gym machines for the lower limbs and free weights for the upper extremities.

Behavioral: Traditional resistance training

Interventions

For each resistance exercise session, 6 to 7 generic exercises will be performed, involving small and large muscle groups (leg extension, leg curl, biceps curl, triceps extension, seated row, shoulder flexion, and shoulder raise). They will perform with 4 sets of 8 repetitions, with a break between exercises of 1 minute and between sets of 2 minutes. They perform those exercises with high intensity (ever 10 on the OMNI-RES Scale).

Eccentrically strengthened resistance exercise

For each resistance exercise session, 6 to 7 generic exercises will be performed, involving small and large muscle groups (leg extension, leg curl, biceps curl, triceps extension, seated row, shoulder flexion, and shoulder raise). They will perform with 4 sets of 8-12 repetitions, with a break between exercises of 1 minute and between sets of 2 minutes. They perform those exercises with 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:

  • Elderly women with uncontrolled chronic diseases.
  • Clinical diagnosis of psychiatric illness.
  • Women who have undergone or are expected to undergo surgical procedures during the interventions.
  • Elderly women diagnosed with joint diseases such as osteoarthritis and arthrosis.
  • Participation in aerobic or resistance exercise programs at least 2 times a week for the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Viçosa

Viçosa, Minas Gerais, 36570-900, Brazil

Location

Related Publications (1)

  • Andres Perez Bedoya E, Puerta-Lopez LF, Garcia Agostinho PA, Reis Cota AD, Patrocinio de Oliveira CE, Araujo Carneiro-Junior M, Patino-Villada FA, Costa Moreira O. Flywheel resistance training and depressive symptoms in older women: a randomized controlled trial. Aging Ment Health. 2025 Nov 7:1-14. doi: 10.1080/13607863.2025.2575025. Online ahead of print.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Édison A. Pérez Bedoya, PhD

    Federal University of Vicosa

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 20, 2023

Study Start

May 1, 2023

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations