Effects of Resistance Exercises in Hereditary Sensory-Motor Neuropathy (Charcot-Marie-Tooth Disease)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-29
SponsorUniversidad de La Frontera
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Progressive Resistance Exercise Training
Other interventionProgressive Resistance Exercise Training Supervised (RET) focusing on lower limbs. Warm-up (5 min cycling), followed by 5 sets of leg press, leg extension, leg curl, and weighted dorsiflexion. Cool-down with flexibility exercises. Load progression from 60% to 80% of 1Repetition Maximum across 8 weeks. Participants must complete ≥80% of sessions. Evaluators of pre- and post-intervention outcomes will be blinded.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Charcot Marie Tooth (CMT Group)Experimental treatment 1 intervention
Group B: CONTROL GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in muscle echogenicity as marker of muscle quality
.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.
Time frame
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.2
Changes in muscle thickness as marker of muscle quality
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).
Time frame
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.Secondary outcomes
1
Changes in muscle architecture through ultrasonographic evaluation (fascicle length and pennation angle)
Measurements will be performed on the tibialis anterior muscle of both lower limbs using ultrasonography (GE Logiq e BT11, General Electric, Boston, MA, USA) with a 10-MHz linear transducer by an evaluator experienced in muscle ultrasound analysis. For the assessment, participants will be positioned in a seated posture with knees flexed in neutral position and feet supported without footwear. The head of the fibula and the center of the lateral malleolus will be used as anatomical landmarks, where the total length will be measured and divided into three portions. Measurements will be obtained with the transducer placed transversely on the muscle belly located in the upper third of the distance measured between the two aforementioned bony landmarks. The analysis of muscle architecture will be performed using the public-domain software NIH ImageJ. This quantification will also be carried out by a blinded evaluator.
Time frame
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.2
Serum creatine kinase concentration as a biomarker of muscle quality.
Blood samples will be collected in the morning after a 12-hour fasting period from a superficial vein in the cubital fossa. Samples will be obtained on the first evaluation day (1 week before starting training) and 48 hours after the final training session. They will be drawn into serum-separator tubes without anticoagulant, centrifuged at 2500 rpm for 15 minutes, and the resulting serum will be aliquoted into microtubes and stored at -80 °C for subsequent analysis of Creatine Kinase levels.
Time frame
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.3
Changes in total body mass
Total and regional lean body mass will be assessed by bioelectrical impedance analysis (HBF-514C, Omron©, Japan) after overnight fasting, with participants standing. Lean body mass will be expressed in kilograms (kg) and as a percentage of total body mass (%).
Time frame
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.4
Variation in anthropometric measurements
anthropometric measurements will include body weight measured in kilograms (Kg), height, waist to hip, chest, thigh, and calf circumferences, as well as knee height and leg length mesuared in milimiters (mm). Weight and height will be obtained with a SECA® platform scale and stadiometer (Madison, WI, USA), while circumferences will be measured with a retractable SECA® measuring tape at standardized anatomical landmarks. Weight and height will be combined to report BMI in kg/m\^2
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov