Effects of a Resistance Exercise Training Program on Skeletal Muscle Quality, Functional Capacity, and Quality of Life in Young Individuals With and Without Hereditary Sensorimotor Polyneuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Changes in muscle echogenicity as marker of muscle quality
研究概览
简要总结
The goal of this clinical trial is to compare the effects of an 8-week resistance exercise training program on skeletal muscle quality, functional capacity, and quality of life in young individuals aged 15 to 29 years, with and without Hereditary Sensorimotor Polyneuropathy (HSPN).
The main questions to answer are:
What is the effect of an 8-week resistance exercise training program on skeletal muscle quality, functional capacity, and quality of life in young individuals with and without HSPN?
Will the percentage of improvement after the program be greater in participants with HSPN compared to those without, due to greater baseline alterations?
Researchers will compare the resistance exercise training program with baseline conditions to determine its effectiveness in improving skeletal muscle quality, functional capacity, and quality of life.
Participants will undergo a supervised lower-limb resistance exercise program (3x/week) for 8 weeks. The intervention will include progressive loads from 60% to 80% of 1-Repetition Maximum (1RM), with exercises targeting the major lower limb muscle groups. All participants will complete pre- and post-intervention evaluations, including ultrasound assessment of muscle architecture, functional capacity tests, strength measurements, body composition analysis, and quality of life questionnaires.
详细描述
Introduction: Hereditary sensorimotor polyneuropathy (HSPN), also known as Charcot-Marie-Tooth disease (CMT), is the most prevalent group of hereditary neuromuscular disorders. It is characterized by muscle distal weakness, muscle atrophy, sensory loss, balance impairments, skeletal deformities and, in some cases, respiratory dysfunction. These impairments lead to reduced muscle quality, functional capacity, and quality of life. Muscle quality encompasses both morphological and functional aspects of skeletal muscle, including muscle architecture, composition, and strength.
Resistance exercise training (RET) has been shown to improve strength, muscle morphology, and functional performance in various populations. However, there is limited evidence on its effectiveness in individuals with HSPN, particularly in young adults. No studies to date have compared the effects of lower-limb-focused RET on muscle quality, functional capacity, and quality of life in young adults with and without HSPN.
Objectives:
The primary objetive of this study will be to assess the change in muscle thickness and echogenicity as markers of muscle quality, evaluated through ultrasonography in the tibialis anterior muscles of the lower limbs of participants undergoing 8 weeks of resistance training
Secondary objectives include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The expert evaluators of the pre- and post-intervention variables will be blinded.
入排标准
- 年龄范围
- 15 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women between 15 and 29 years of age with a diagnosis of hereditary sensorimotor polyneuropathy (HSPN) in any of its subtypes, living in the community (for experimental group).
- •Healthy men or women between 15 and 29 years of age living in the community (for control group).
- •Having active ankle movement within a range from plantarflexion to at least 0° of ankle dorsiflexion, allowing for strength training.
排除标准
- •Osteoarticular or mobility impairments that prevent safe performance of resistance exercise training (e.g., ankle arthrodesis).
- •Use of nutritional supplements that may affect skeletal muscle regulation (leucine, glutamine, casein, whey protein, fatty acids, creatine, among others).
- •Untreated and/or uncontrolled chronic diseases or intellectual disability.
- •History of surgery
- •Participation in a resistance exercise training program within the past 6 months.
结局指标
主要结局
Changes in muscle echogenicity as marker of muscle quality
时间窗: The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.
.Echogenicity of the tibialis anterior muscle in both lower limbs will be assessed using ultrasonography (GE Logiq e BT11, 10-MHz linear transducer) by an experienced examiner. Participants will be seated with knees flexed and feet supported; the head of the fibula and lateral malleolus will serve as reference points. Echointensity will be analyzed in ImageJ from transverse images, excluding bone and fascia, and expressed as 0-255 A.U.
Changes in muscle thickness as marker of muscle quality
时间窗: The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.
Muscle thickness of the tibialis anterior muscle in both lower limbs will be assessed using ultrasonography (GE Logiq e BT11, 10-MHz linear transducer). Participants will be seated with knees flexed and feet supported; the head of the fibula and the lateral malleolus will serve as anatomical reference points. Muscle thickness will be defined as the orthogonal distance between the superficial and deep aponeuroses, measured at the midpoint of the transverse ultrasonographic image expressed in millimeters (mm).
次要结局
- Changes in muscle architecture through ultrasonographic evaluation (fascicle length and pennation angle)(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.)
- Serum creatine kinase concentration as a biomarker of muscle quality.(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.)
- Changes in total body mass(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 4 days after signing the informed consent, and the second, 4 days after completing the treatment.)
- Variation in anthropometric measurements(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 4 days after signing the informed consent, and the second, 4 days after completing the treatment.)
- Changes in aerobic capacity(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 4 days after signing the informed consent, and the second, 4days after completing the treatment.)
- Changes in respiratory muscle strength(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 4 days after signing the informed consent, and the second, 4 days after completing the treatment.)
- Changes in maximal handgrip strength(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.)
- Changes in overall lower-limb strength(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.)
- Changes in overall upper-limb strength(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.)
- Changes in maximal voluntary isometric strength(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.)
- Changes in functional ankle muscle strength(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.)
- Changes maximal lower-limb muscle strength(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 2 days after signing the informed consent, and the second, 2 days after completing the treatment.)
- Changes in balance and gait performance(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 4 days after signing the informed consent, and the second, 4 days after completing the treatment.)
- Changes in health-related quality of life (HRQoL)(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 4 days after signing the informed consent, and the second, 4 days after completing the treatment.)
- Changes physical activity levels(The evaluation will be conducted twice, before and after the 8-week intervention: the first, 4 days after signing the informed consent, and the second, 4 days after completing the treatment.)
研究者
Fernando Javier Valenzuela Aedo
Clinical Professor
Universidad de La Frontera