Sarcopenic ObesityNCT06895122
Effectiveness of Different Types of Training in Older Adults With Sarcopenic Obesity
A study testing High resistance training and Multicomponent Training in people with Sarcopenic Obesity and Obesity and Overweight, run by University of Salamanca at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Sarcopenic Obesity, Obesity and Overweight, Sarcopenia
- What is being tested?
- High resistance training and Multicomponent Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Women older than 65 years.
- Diagnosis of sarcopenic obesity (SMI < 5.5 kg/m2, BMI > 30 kg/m2)
Who cannot join
- Tumors
- Pacemakers
- Fibrillations
- Cardiac pathology or uncontrolled hypertension
- History of severe trauma/recent cervical surgery
- Uncontrolled systemic and inflammatory pathologies
Show all 10Show fewer
- Congenital collagen compromise
- Presence of difficulties in performing the Initial Evaluation tests
- Language barriers
- Pending litigation or legal claim
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of High-speed Resistance and Multicomponent Training in Older Adults With Sarcopenic Obesity: a Randomized Clinical Trial
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)).
Read the 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
- Being tested
- High resistance training, Multicomponent Training
- Keywords
- Resistance training, Exercise, Older adults, Multicomponent training
- Medical subject headings
- Obesity, Overweight, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resistance trainingProcedure or surgery
Also called Power training
Participants will perform the exercises at high speed, emphasizing explosive movements to maximize muscle power development.
Multicomponent TrainingProcedure or surgery
Various exercise modalities are integrated, including aerobic training, mobility, strength, balance, and coordination exercises.
| Study group | Role | What they receive |
|---|---|---|
| High Speed Resistance Training | Experimental | 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 Receives: Procedure: High resistance training |
| Multicomponent training | Active comparator | 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. Receives: Procedure: Multicomponent Training |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Index (SMI)
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
Measured: 30 weeks
Secondary outcomes (7)
Body Fat Percentage (BF%)
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.
Measured: 30 weeks
Grip strength test
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.
Measured: 30 weeks
Chair stand test
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
Measured: 30 weeks
Body Mass Index (BMI)
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.
Measured: 30 weeks
Short Physical Performance Battery (SPPB)
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.
Measured: 30 weeks
Gait speed
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.
Measured: 30 weeks
Timed Up and Go (TUG)
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.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Sep 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Polo Ferrero, University of Salamanca
- Investigators
- Roberto Méndez Sánchez, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895122
- Sponsor's protocol ID
- OB_SARC_
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-speed Resistance and Multicomponent Training in Older Adults With Sarcopenic Obesity: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06895122
- Acronym / sponsor ID
- OB_SARC_
- Conditions
- Sarcopenic Obesity, Obesity and Overweight, Sarcopenia
- Keywords
- Resistance training, Exercise, Older adults, Multicomponent training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Longitudinal.
| Arm | Type | Receives |
|---|---|---|
| High Speed Resistance Training | Experimental | Procedure: High resistance trainingThe 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 |
| Multicomponent training | Active comparator | Procedure: Multicomponent TrainingThe 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Women older than 65 years.
- Diagnosis of sarcopenic obesity (SMI < 5.5 kg/m2, BMI > 30 kg/m2)
Key exclusion criteria (10 listed)
- Tumors
- Pacemakers
- Fibrillations
- Cardiac pathology or uncontrolled hypertension
- History of severe trauma/recent cervical surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High resistance trainingAlso: Power trainingParticipants will perform the exercises at high speed, emphasizing explosive movements to maximize muscle power development. | Procedure or surgery | High Speed Resistance Training |
| Multicomponent TrainingVarious exercise modalities are integrated, including aerobic training, mobility, strength, balance, and coordination exercises. | Procedure or surgery | Multicomponent training |
Primary outcome
Skeletal Muscle Index (SMI)
Time frame: 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
7 secondary outcomes
Body Fat Percentage (BF%)
Time frame: 30 weeks
Grip strength test
Time frame: 30 weeks
Chair stand test
Time frame: 30 weeks
Body Mass Index (BMI)
Time frame: 30 weeks
Short Physical Performance Battery (SPPB)
Time frame: 30 weeks
Gait speed
Time frame: 30 weeks
Timed Up and Go (TUG)
Time frame: 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Méndez Sánchez, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resistance training and Multicomponent Training in people with Sarcopenic Obesity and Obesity and Overweight, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Index (SMI) (time frame: 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.