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临床试验/NCT05910632
NCT05910632已完成不适用

Effect of Eight Weeks of Eccentrically Reinforced Resistance Training Versus Traditional Resistance Training on Depressive Symptoms, Physical and Executive Function in Sedentary Older Women

Federal University of Vicosa1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Changes in baseline depressive symptoms at two months.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Hidden and opaque envelope technique.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Eccentrically strengthened resistance exercise (Behavioral)

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.

干预措施: Traditional resistance training (Behavioral)

结局指标

主要结局

Changes in baseline depressive symptoms at two months.

时间窗: Baseline and 8-weeks

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.

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

时间窗: Baseline and 8-weeks

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.

Change in Inhibitory control at two months

时间窗: Baseline and 8-weeks

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.

Change in Working memory at two months

时间窗: Baseline and 8-weeks

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.

Change in Cognitive flexibility at two months

时间窗: Baseline and 8-weeks

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.

Change in baseline test Time up and go at two months.

时间窗: Baseline and 8-weeks

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.

次要结局

  • Change In Baseline bone mineral density At Two Months(Baseline and 8-weeks)
  • Resting heart rate(Baseline and 8-weeks)
  • Abdominal circumference(Baseline and 8-weeks)
  • 1RM test(Baseline and 8-weeks)
  • Change In Baseline Total body mass at two months(Baseline and 8-weeks)
  • Change In Baseline lean mass At Two Months(Baseline and 8-weeks)
  • Change In Baseline bone loss index throughout life At Two Months(Baseline and 8-weeks)
  • Blood pressure(Baseline and 8-weeks)
  • Change in baseline Falls Efficacy Scale-International at to months(Baseline and 8-weeks)
  • Change In Baseline bone mineral content At Two Months(Baseline and 8-weeks)
  • Changes In Baseline Sleep latency At Two Months.(Baseline and 8-weeks)
  • Changes In Baseline Total sleep time At Two Months.(Baseline and 8-weeks)
  • Maximum isometric voluntary contraction(Baseline and 8-weeks)
  • Change in baseline quality of life time at two months.(Baseline and 8-weeks)
  • Muscle power(Baseline and 8-weeks)
  • Number of participants with adverse events or damages(8-weeks)
  • Changes in baseline sleepiness at two months(Baseline and 8-weeks)
  • Changes in baseline active time at two months.(Baseline and 8-weeks)
  • Changes in baseline sleep quality at two months.(Baseline and 8-weeks)
  • Changes In Baseline Wakefulness after sleep onset At Two Months.(Baseline and 8-weeks)
  • Changes in baseline chronotype at two months.(Baseline and 8-weeks)
  • Changes In Baseline Sleep efficiency At Two Months.(Baseline and 8-weeks)

研究者

发起方
Federal University of Vicosa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Édison Andrés Pérez Bedoya

Principal Investigator

Federal University of Vicosa

研究点 (1)

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