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

Not Applicable

Completed

• Conditions: Sarcopenic Obesity; Obesity and Overweight; Sarcopenia

• Registration Number: NCT06895122
• Lead Sponsor: University of Salamanca

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.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Skeletal Muscle Index (SMI)	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

Secondary Outcome Measures

Name	Time	Method
Body Fat Percentage (BF%)	30 weeks	BF% represents the proportion of total body weight composed of fat mass. It is a key indicator of body composition and metabolic health, with higher values often associated with increased health risks.
Grip strength test	30 weeks	Accurate measurement of hand grip strength requires the use of a hand dynamometer (Jamar Plus) calibrated under well-defined (standardized) test conditions. Force values less than 16 Kg are considered positive.
Chair stand test	30 weeks	It can be used as an indicator of the strength of the lower limb muscles. It measures the amount of time a patient needs to get up five times from a sitting position without using their arms. It will help us to affirm that the person has a probable sarcopenia. Times greater than 15 seconds are considered positive
Body Mass Index (BMI)	30 weeks	BMI is a measure used to assess body weight in relation to height, calculated as weight in kilograms divided by height in meters squared (BMI = kg/m²). A BMI of 30 kg/m² or higher is classified as obesity.
Short Physical Performance Battery (SPPB)	30 weeks	Test to assess physical performance and degree of frailty consisting of 3 subtests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.
Gait speed	30 weeks	It is considered a fast, safe and very reliable test for sarcopenia, in a distance of 4 meters, values greater than 0.8 m/s are considered positive.
Timed Up and Go (TUG)	30 weeks	A predictive test for frailty and falls, where individuals are asked to get up from a standard chair, walk to a marker 3 m away, turn around, and sit down again. Times greater than 20 seconds are considered positive.

Trial Locations

Locations (1)

University of Salamanca; 🇪🇸 Salamanca, Spain