Effectiveness of Different Types of Training in Older Adults With Sarcopenic Obesity

NCT ID: NCT06895122

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-31

Brief Summary

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)).

Detailed Description

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.

Statistical Analysis: Normality tests and baseline comparisons will be conducted to confirm group homogeneity. Depending on data distribution, parametric or non-parametric tests will be applied to assess intra-group changes. To compare the effects between groups, repeated measures ANOVA will be used when assumptions of normality and sphericity are met, whereas mixed-effects models will be applied for handling missing data. If normality is violated, the Kruskal-Wallis test will be used. When significant differences are found, post-hoc comparisons will be performed using Bonferroni or Tukey corrections. A significance level of α = 0.05 will be considered. All statistical analyses will be conducted using SPSS version 28.0.

Ethical Considerations: The study has received approval from the Ethics Committee for Drug Research (CEIm) of the Salamanca Health Area. All participants will provide informed consent after being fully briefed on the study's objectives, potential risks, and expected benefits. The research follows the ethical principles outlined in the Declaration of Helsinki, Law 14/2007 on Biomedical Research, and other relevant legal and ethical guidelines applicable to the study's nature.

Conditions

Sarcopenic Obesity; Obesity and Overweight; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

High resistance training

Intervention Type: PROCEDURE

Participants will perform the exercises at high speed, emphasizing explosive movements to maximize muscle power development.

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.

Group Type: ACTIVE_COMPARATOR

Multicomponent Training

Intervention Type: PROCEDURE

Various exercise modalities are integrated, including aerobic training, mobility, strength, balance, and coordination exercises.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High resistance training

Participants will perform the exercises at high speed, emphasizing explosive movements to maximize muscle power development.

Intervention Type: PROCEDURE

Multicomponent Training

Various exercise modalities are integrated, including aerobic training, mobility, strength, balance, and coordination exercises.

Intervention Type: PROCEDURE

Other Intervention Names

Power training

Eligibility Criteria

Inclusion Criteria

• Women older than 65 years.
• Diagnosis of sarcopenic obesity (SMI < 5.5 kg/m2, BMI > 30 kg/m2)

Exclusion Criteria

• Tumors
• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Luis Polo Ferrero

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Méndez Sánchez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Locations

University of Salamanca

Salamanca, , Spain

Countries

Spain

Other Identifiers

OB_SARC_

Identifier Type: -

Identifier Source: org_study_id