Effectiveness of High-speed Resistance and Multicomponent Training in Older Adults With Sarcopenic Obesity: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Skeletal Muscle Index (SMI)
研究概览
简要总结
This study is a randomized, parallel-group, double-blind clinical trial. The primary aim is to assess the effectiveness of power-based resistance training, multimodal exercise incorporating non-specific movements, and a control group in improving functionality and body composition in women over 65 years old with pre-sarcopenia. The intervention will take place over 30 weeks, with three training sessions per week in both experimental groups. Assessments will be conducted at two time points: before and after the intervention. Evaluated parameters will include functionality (Timed Up & Go test (TUG), chair stand test, handgrip strength, and Short Physical Performance Battery (SPPB)) and body composition (body fat percentage, skeletal muscle index (SMI), appendicular skeletal muscle mass (ASM), waist circumference, waist-to-hip ratio, body weight, and body mass index (BMI)).
详细描述
Design: This study is a randomized controlled clinical trial with three parallel groups, recruiting women over 65 years old with sarcopenic obesity. Participants will be randomly assigned to one of three intervention groups. The study will span 8 months, with two assessment points: an initial evaluation and a final follow-up at 8 months. Throughout the intervention period, participants will attend three supervised sessions per week, each lasting 50 minutes.
Setting: The study will take place in the Salamanca Health Area, in collaboration with the Research, Teaching, and Care Unit of the Faculty of Nursing and Physiotherapy at the University of Salamanca and the Department of Older Adults of the Salamanca City Council.
Interventions: The three intervention groups include: (1) a Multicomponent Exercise Program (MT); (2) a Muscle Strength Training Program (M-RT); and (3) a Control Group (CG) with no structured exercise intervention. Both MT and M-RT sessions will follow a standardized format, incorporating exercises based on the guidelines of the American College of Sports Medicine (ACSM). The strength component of the MT program will progressively increase in speed, adjusting to the maximum capability of each participant.
Study Population: A total of 33 women aged 65 years and older with sarcopenic obesity, residing in Salamanca, will be enrolled and randomly allocated into the three study groups in a 1:1:1 ratio. Randomization will be carried out using Epidat 4.2 software, and the sample size was determined using GRANMO version 8.
Outcome Measures: The primary outcome is the Skeletal Muscle Index (SMI). Secondary outcomes include functional assessments (Timed Up & Go [TUG] test, chair rise test, handgrip strength test, and Short Physical Performance Battery [SPPB]), body composition measures (percentage of body fat, appendicular skeletal muscle mass [ASM], waist circumference, waist-to-hip ratio, body weight, and body mass index [BMI]), and gait speed. Descriptive statistics will be reported as mean ± standard deviation for continuous variables and as frequency distributions for categorical variables.
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
Blinding was performed on the study hypothesis and on the participants assigned to each group. Both the evaluating researchers and the statistical researcher were blinded.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 65 years.
- •Diagnosis of sarcopenic obesity (SMI < 5.5 kg/m2, BMI > 30 kg/m2)
排除标准
- •Pacemakers
- •Fibrillations
- •Cardiac pathology or uncontrolled hypertension
- •History of severe trauma/recent cervical surgery
- •Uncontrolled systemic and inflammatory pathologies
- •Congenital collagen compromise
- •Presence of difficulties in performing the Initial Evaluation tests
- •Language barriers
- •Pending litigation or legal claim
研究组 & 干预措施
Control Group
Participants assigned to this group will maintain their usual dietary habits and physical activity levels without making any lifestyle modifications throughout the study. They will not engage in the muscle power-based strength training program or participate in any other structured, supervised, or systematic exercise program.
High Speed Resistance Training
The core component of the H-RT program will include a variety of exercises targeting both the upper and lower limbs. These exercises consist of wall push-ups, arm raises, elbow flexion and extension, weighted pronosupination, hand presses, knee and hip hinge squats, deadlifts, frontal and sagittal plane lunges, and heel raises. The program will be structured into three progressive phases:
Phase 1 - Adaptation: During the first month, participants will focus on learning the correct technique for all upper and lower limb exercises to ensure proper execution.
Phase 2 - Strength Training: Over the next two months, resistance exercises will be performed at both slow and controlled speeds, reinforcing movement patterns established in the initial phase.
Phase 3 - High-Speed Resistance Training: In the final five months, progressive overload will be applied, with a gradual increase in execution speed and exercise intensity to enhance muscle power and improve overall function
干预措施: High resistance training (Procedure)
Multicomponent training
The core of the multicomponent exercise program incorporates various exercise modalities, including aerobic training, mobility, strength, balance, and coordination exercises. Additionally, playful activities and cognitive tasks are integrated to enhance the program's overall effects. These include games involving colors, numbers, letters, laterality (right-left distinction), memory exercises, and more. The progression for each modality follows a structured approach:
Aerobic Training: Begins with continuous exercise, transitions to interval training, and progressively reduces rest periods.
Strength Training: Gradually increases the number of sets and repetitions while decreasing rest time.
Balance Training: Starts with static exercises and progresses to more challenging tasks, incorporating blindfolds, perturbations, and dynamic balance drills.
Coordination and Cognitive Tasks: Exercises become progressively more complex, requiring faster decision-making and more intricate movements.
干预措施: Multicomponent Training (Procedure)
结局指标
主要结局
Skeletal Muscle Index (SMI)
时间窗: 30 weeks
The SMI assesses muscle mass relative to body size, calculated as appendicular skeletal muscle mass (ASM) divided by height squared (kg/m²). Sarcopenia is diagnosed in women when SMI is \<5.5 kg/m²
次要结局
- Body Fat Percentage (BF%)(30 weeks)
- Grip strength test(30 weeks)
- Chair stand test(30 weeks)
- Body Mass Index (BMI)(30 weeks)
- Short Physical Performance Battery (SPPB)(30 weeks)
- Gait speed(30 weeks)
- Timed Up and Go (TUG)(30 weeks)
研究者
Luis Polo Ferrero
Associate Professor
University of Salamanca