Clinical trial NCT05910632: Eccentrically Reinforced Resistance Training vs. Traditional Resistance Training in Sedentary Older Women
Official title: Effect of Eight Weeks of Eccentrically Reinforced Resistance Training Versus Traditional Resistance Training on Depressive Symptoms, Physical and Executive Function in Sedentary Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Physical Functional Performance
Executive Function
Keywords: Depression
Physical Function
Executive Function
Lead sponsor: Federal University of Vicosa
Sponsor class: OTHER
First posted: 2023-06-20
Enrollment: 36
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 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.

Detailed description: Twenty-two women will be randomly assigned to two groups (eccentrically enhanced resistance training and traditional resistance training). Interventions will be conducted in the Department of physical education of federal university of Viçosa. All sessions will be supervised by physical education professors. Follow-up will be done through WhatsApp messages and phone calls. Both groups will have a training frequency of 2 times per week for eight weeks. Eccentrically augmented resistance sessions will be performed on the multi-gym flywheel machine for lower and upper limbs for women in the experimental group. The control group will use machines and free weights. In each training session, 6 to 7 exercises will be performed, with 4 sets of 8-12 repetitions, with a rest between exercises of 1 minute and between sets of 2 minutes. The resistance exercise progression is carried out until the woman, with the same mobilized weight in kg, exceeds the maximum number of repetitions suggested by the researchers. Each resistance exercise session will include 6-7 generic exercises involving small and large muscle groups (leg extension, leg curl, biceps curl, triceps extension, seated row, shoulder flexion, and shoulder raise).

Each participant will undergo an initial and final assessment to measure the muscle strength of the lower extremities. The depressive state will be evaluated with a short version of the Geriatric Depression Scale (GDS), validated in Brazil. The physical function will be evaluated with the Test Timed Up and Go (TUG) and Short Physical Performance Battery (SPPB). In addition, executive function will be evaluated with the Victoria Stroop test. Work memory, Digit span forward, Backward and Cognitive flexibility with Trail marking test (Trail A and Trail B).

The Brazilian version of WHOQOL-Bref will be used to assess quality of life. To evaluate the maximum isometric voluntary contraction (MIVC) of the lower extremities, a load cell or extensiometric cell (MK®, model CSL / ZL-1 T, MK Controle, Brazil) with a sampling frequency of 1000 Hz will be used. To perform the 1RM test, the knee extension exercise is performed on a BH fitness® Nevada Pro-t extension machine. The evaluation of lower limb muscular strength will be performed with the same knee extension machine used in training sessions, starting from the same initial position (90o knee flexion) and reaching. Body composition is assessed using a dual-energy x-ray absorptiometry (DXA) full-body scan (GE Healthcare Lunar Prodigy Advance DXA System, software version 13.31). A minimus® III aneroid sphygmomanometer with a maximum error of +/- 3 mmHg will be used. Systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean blood pressure (MBP) are calculated. MBP is obtained with the following mathematical operation: PAD + PAD + PAS / 3. To measure HRR, women are asked to sit for 3 minutes. After that moment, this variable will be taken manually in the radial or carotid pulse of the right side for 60 seconds. The perimeter of the abdomen is measured with a metal tape with the subject's feet, at a midpoint between the lower costal margin and the iliac crest, at the end of a normal expiration.

The risk of falling will be evaluated with the Falls Efficacy Scale-International (FES-I).

Sleep-wake cycle evaluation with Actigraph GT3X-BT Accelerometer Sleep Quality Assessment: Pittsburg Sleep Quality Index - PSQI Chronotype Assessment: Hortensia and Ostberg Questionnaire Sleepiness Assessment: Epworth Sleepiness Scale.

Eligibility criteria: Inclusion Criteria:

1. 60 years or older.
2. Self-reported proficiency in speaking, writing, and understanding Portuguese.
3. Willingness and availability to participate in all trial procedures.
4. Good vision in at least one eye.
5. Absence of any medical contraindications for engaging in physical exercise.
6. Engage in less than 150 minutes of physical activity per week.
7. Not clinical diagnosis of major depressive disorder at the time of the interventions.

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in baseline depressive symptoms at two months.
timeFrame: Baseline and 8-weeks
measure: Change in baseline test Time up and go at two months.
timeFrame: Baseline and 8-weeks
measure: Change in baseline balance test, mark speed, and sit and stand chair at two months
timeFrame: Baseline and 8-weeks
measure: Change in Inhibitory control at two months
timeFrame: Baseline and 8-weeks
measure: Change in Working memory at two months
timeFrame: Baseline and 8-weeks
measure: Change in Cognitive flexibility at two months
timeFrame: Baseline and 8-weeks
Secondary outcomes:
measure: Change in baseline quality of life time at two months.
timeFrame: Baseline and 8-weeks
measure: Maximum isometric voluntary contraction
timeFrame: Baseline and 8-weeks
measure: 1RM test
timeFrame: Baseline and 8-weeks
measure: Muscle power
timeFrame: Baseline and 8-weeks
measure: Change In Baseline Total body mass at two months
timeFrame: Baseline and 8-weeks
measure: Change In Baseline lean mass At Two Months
timeFrame: Baseline and 8-weeks
measure: Change In Baseline bone mineral content At Two Months
timeFrame: Baseline and 8-weeks
measure: Change In Baseline bone mineral density At Two Months
timeFrame: Baseline and 8-weeks
measure: Change In Baseline bone loss index throughout life At Two Months
timeFrame: Baseline and 8-weeks
measure: Blood pressure
timeFrame: Baseline and 8-weeks
measure: Resting heart rate
timeFrame: Baseline and 8-weeks
measure: Abdominal circumference
timeFrame: Baseline and 8-weeks
measure: Number of participants with adverse events or damages
timeFrame: 8-weeks
measure: Change in baseline Falls Efficacy Scale-International at to months
timeFrame: Baseline and 8-weeks
measure: Changes in baseline active time at two months.
timeFrame: Baseline and 8-weeks
measure: Changes In Baseline Sleep latency At Two Months.
timeFrame: Baseline and 8-weeks
measure: Changes in baseline sleep quality at two months.
timeFrame: Baseline and 8-weeks
measure: Changes In Baseline Wakefulness after sleep onset At Two Months.
timeFrame: Baseline and 8-weeks
measure: Changes in baseline chronotype at two months.
timeFrame: Baseline and 8-weeks
measure: Changes In Baseline Total sleep time At Two Months.
timeFrame: Baseline and 8-weeks
measure: Changes In Baseline Sleep efficiency At Two Months.
timeFrame: Baseline and 8-weeks
measure: Changes in baseline sleepiness at two months
timeFrame: Baseline and 8-weeks
Other outcomes:
Locations:
city: Viçosa
country: Brazil
facility: Federal University of Viçosa
state: Minas Gerais
Study officials:
affiliation: Federal University of Vicosa
name: Édison A. Pérez Bedoya, PhD
role: PRINCIPAL_INVESTIGATOR
References: