Clinical trial NCT06758206: Flywheel Resistance Training and Traditional Resistance Training in Older Women With Sedentary Behaviors
Official title: Effect of 10 Months of Flywheel Resistance Training Versus Traditional Resistance Training on Depressive Symptoms, Physical and Executive Function in Older Women With Sedentary Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Physical Function
Executive Function
Resistance Training
Keywords: depressive symptoms
Physical Function
Executive function
Resistance training
Eccentric action
Older women
Lead sponsor: Federal University of Vicosa
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 74
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Seventy Four older women will be randomly assigned to two groups: Flywheel resistance training and traditional resistance training. The interventions will be conducted at the Physical Education Department of the Federal University of Viçosa, with all sessions supervised by Physical Education professionals. Follow-up will be carried out through WhatsApp messages and phone calls. Both groups will train twice a week for 10 months. Participants in the experimental group will perform Flywheel resistance training on a multi-leg isoinertial machine targeting upper and lower body muscles, while the control group will use traditional machines and free weights. Each session will include 6 to 7 exercises, performed in 4 sets of 8 to 12 repetitions, with a 2-minute rest between sets and exercises. Training progression will be adjusted based on the participant's ability to exceed the maximum suggested repetitions with the same mobilized weight. Exercises will target various muscle groups, including leg extension, leg curl, bicep curl, tricep extension, seated row, shoulder flexion, and shoulder elevation.

Participants will be assessed at three time points during the training program: pre-intervention, 5 months, and 10 months after the intervention starts. Lower limb muscle strength will be evaluated using one-repetition maximum (1RM) tests on a knee extension machine and through maximal voluntary isometric contraction (MVIC), assessed with a load cell. Depressive symptoms will be measured using the Geriatric Depression Scale (GDS), validated for use in Brazil. Physical function will be assessed through the Timed Up and Go (TUG) test and the Senior Fitness Test (SFT). Executive function will be evaluated using the Victoria Stroop test, Digit Span (forward and backward), and the Trail Making Test (parts A and B). Quality of life will be assessed using the Brazilian version of the WHOQOL-Bref, while body composition will be analyzed through dual-energy X-ray absorptiometry (DXA). Blood pressure (systolic, diastolic, and mean arterial pressure) will be measured using an aneroid sphygmomanometer, and resting heart rate will be manually recorded after 3 minutes in a seated position. Abdominal circumference will be measured with a metal tape at the midpoint between the lower costal margin and the iliac crest, at the end of a normal expiration. Fall risk will be assessed using the Falls Efficacy Scale-International (FES-I) and the Berg Balance Scale. Fatigue symptoms will be evaluated using the Fatigue Symptom Inventory (FSI).

Eligibility criteria: Inclusion Criteria:

* 60 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in baseline depressive symptoms at ten months.
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline test Time up and go at ten months.
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline 30-s chair stand at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline 30-s arm curl at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline 6-min walk at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline chair sit-and-reach at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline back scratch at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline 8-foot up-and-go at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in Inhibitory control at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in Working memory at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in Cognitive flexibility at ten months
timeFrame: Baseline, 5 and 10 months
Secondary outcomes:
measure: Change in baseline quality of life time at ten months.
timeFrame: Baseline, 5 and 10 months
measure: Maximum isometric voluntary contraction
timeFrame: Baseline, 5 and 10 months
measure: 1RM test
timeFrame: Baseline, 5 and 10 months
measure: Muscle power
timeFrame: Baseline, 5 and 10 months
measure: Change In Baseline Total body mass at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change In Baseline lean mass At Ten Months
timeFrame: Baseline, 5 and 10 months
measure: Change In Baseline bone mineral content At Ten Months
timeFrame: Baseline, 5 and 10 months
measure: Change In Baseline bone mineral density At Ten Months
timeFrame: Baseline, 5 and 10 months
measure: Change In Baseline bone loss index throughout life At Ten Months
timeFrame: Baseline, 5 and 10 months
measure: Blood pressure
timeFrame: Baseline, 5 and 10 months
measure: Resting heart rate
timeFrame: Baseline, 5 and 10 months
measure: Abdominal circumference
timeFrame: Baseline, 5 and 10 months
measure: Number of participants with adverse events or damages
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline Falls Efficacy Scale-International at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline Berg Balance Scale at ten months
timeFrame: Baseline, 5 and 10 months
measure: Change in baseline Fatigue Symptom Inventory at ten months
timeFrame: Baseline, 5 and 10 months
Other outcomes:
Locations:
city: Viçosa
country: Brazil
facility: Universidade Federal de Viçosa
state: Minas Gerais
city: Viçosa
country: Brazil
facility: Federal University of Viçosa, Viçosa - Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University Of Viçosa
name: Osvaldo Costa Moreira
role: STUDY_DIRECTOR
affiliation: Antioquia University
name: Edison A Pérez Bedoya
role: STUDY_DIRECTOR
References: