Pre-sarcopeniaPOSARCNCT05870046
Effectiveness of Power Training in Older Women With Pre-sarcopenia
A study testing Power training in women older than 65 years with pre-sarcopenia and Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopenia in people with Pre-sarcopenia and Old Age; Debility, run by University of Salamanca at 1 site in Spain.
Trial summary
This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of resistance training based on power training, multimodal exercise with non-specific exercises and a control group on functionality and body composition in women over 65 years of age with pre-sarcopenia. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-sarcopenia, Old Age; Debility
- What is being tested?
- Power training in women older than 65 years with pre-sarcopenia and Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopenia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2022to 28 Feb 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Women older than 65 years.
- pre-sarcopenia state (chair stand test > 15s or Hand Grip Strength < 16Kg).
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 Power Training Compared With Non-specific Exercises on Functionality and Body Composition in Women Older Than 65 Years With Probable Sarcopenia.
This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of resistance training based on power training, multimodal exercise with non-specific exercises and a control group on functionality and body composition in women over 65 years of age with pre-sarcopenia.
The intervention in both groups will be carried out for 30 weeks, with three weekly sessions. Two evaluations will be performed, one pre-intervention and one post-intervention. Functionality (Timed Up \& Go test (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)) will be evaluated.
Read the detailed description
Design: Randomized, controlled clinical trial with three parallel groups, in which women over 65 years of age will be recruited. Study participants will be assigned to one of the three interventions. The study will have a duration of 8 months. There will be 2 evaluation visits, an initial one, a final one at 8 months. During 8 months there will be 3 weekly sessions lasting 50 minutes.
Scope: The study will be carried out in the Salamanca Health Area, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council.
Interventions: 1) Multimodal Exercise Group (GEM); 2) Muscle Power Exercise Group (GEP); 3) No Exercise Control Group (CG). The GEM and GEP sessions follow the same structural pattern. They will be structured according to the recommendations of the American College of Sports Medicine (ACSM). In the main part of the GEP, strength exercises will be performed and the speed will be progressively increased until the exercises are performed at the maximum speed that each participant can do.
Study population: 104 subjects over 65 years of age from the city of Salamanca will be included, distributed in 3 groups at a 1:1:1 ratio. Randomization will be performed using the Epidat 4.2 program. The sample size was calculated using GRANMO Version 7. 12 April 2012.
The main study variables are: Functionality (Timed Up \& Go test (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)), SARC-F Questionnaire, % RM estimated by force-velocity profile and Gait speed.
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables. Statistical analysis The effect of the intervention on the study variables if the variables are parametric, Student's t-test will be used, and if they are non-parametric, the Wilcoxon test will be used. An alpha risk of 0.05 is set as the limit of statistical significance. The statistical program to be used will be SPSS, v.26.0.
The study will be carried out with the authorization of the Ethics Committee on Drug Research (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. The participants will be informed of the objectives of the project and of the risks and benefits of the examinations and interventions to be performed. The study has been designed and subsequently assessed in accordance with Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
- Conditions
- Pre-sarcopenia, Old Age; Debility
- Being tested
- Power training in women older than 65 years with pre-sarcopenia, Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopenia
- Keywords
- exercise, elderly, resistance training, sarcopenia
- Medical subject headings
- Frailty, Motor Activity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power training in women older than 65 years with pre-sarcopeniaProcedure or surgery
resistance training based on muscle power training, perform the exercises at high speed.
Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopeniaProcedure or surgery
different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises.
| Study group | Role | What they receive |
|---|---|---|
| power exercise group | Experimental | The main part of the muscle power exercise program will have the following exercises: wall push-ups, arm raises, elbow push-ups and extensions, weighted pronosupination, hand press, knee and hip hinge squat, dead weight, front and sagittal plan stride, and heel raises.
It will have different phases:
* 1st phase: exercise adaptation: the correct execution of upper and lower limb exercises will be taught for one month.
* 2nd phase: Resistance training: During the following two months, strength exercises will be performed at slow and normal speed of the movement patterns learned in the training course.
* 3rd phase: Muscle power training: During the last five months. A correct progression of the load and a progressive increase in the speed of execution of the different exercises will be carried out, gradually increasing the levels of difficulty and intensity. Receives: Procedure: Power training in women older than 65 years with pre-sarcopenia |
| multimodal exercise group | Active comparator | The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises, playful activities or games are also included with some activities aimed at working on cognitive functions to reinforce the overall effects of the program, such as games with colors, numbers, letters, right-left laterality, memory, etc.
The progression of the different models is as follows:
* E. Aerobic: Start with continuous work, then intervallic, and decrease rest times in intervallic work.
* E. Strength: Increase sets, repetitions and decrease rest time.
* Balance: start with static and evolve with blindfolds, perturbations, dynamic balance, etc.
* Coordination, and cognitive games will also become more complicated, with more complicated and faster decision making. Receives: Procedure: Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopenia |
| Control group | No intervention | Participants in this group should continue with their usual dietary pattern and level of physical activity, without changing their lifestyle habits during the study period. They will not participate in the strength exercise program based on muscle power, nor will they perform systematic, programmed and supervised physical exercise in any other program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: thirty 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: thirty weeks
Secondary outcomes (7)
SARC-F questionnaire
A simple questionnaire to rapidly diagnose sarcopenia with 5 questions for the initial detection of risk of sarcopenia (5 components: Strength, assistance in walking, rise from a chair, climb stairs, and falls). A score equal to or greater than 4 points better predicts the need for a more comprehensive evaluation.
Measured: thirty weeks
Evaluation of changes in contraction velocity (m/s)
Velocity (m/s) of concentric contraction execution of a full extension of the lower limb will be evaluated to assess the changes in the force-velocity profile after performing the different interventions. It will be measured using the ADR linear encoder device and the mean value of five repetitions will be obtained.
Measured: thirty weeks
Body Mass Index (BMI)
It is a measure used to assess a person's body weight in relation to their height. It is calculated by dividing a person's weight in kilograms by their height in meters squared (BMI = kg/m²).
Measured: thirty 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: thirty 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: thirty 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: thirty weeks
food frequency questionnaire (FFQ)
The 143-item questionnaire of the PREDIMED study, validated in Spain, was used to assess dietary habits. Nutrient intake was calculated using food composition tables, including values for macronutrients (protein, CHO, fat) and essential micronutrients (minerals and vitamins), each with the corresponding unit of measurement.
Measured: thirty weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start15 Feb 2022
- Primary completion31 Dec 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-sarcopeniaStudies 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 prospective, controlled, single-blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870046
- Sponsor's protocol ID
- USalamancaPowerSarcopenia
- Acronym
- POSARC
- Status last verified
- Mar 2025
- First submitted
- 8 May 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Polo-Ferrero L, Recio-Rodriguez JI, Gonzalez-Manzano S, Martin-Vallejo J, Barbero-Iglesias FJ, Montero-Errasquin B, Cruz-Jentoft AJ, Mendez-Sanchez R. Nutritional intake as a determinant of high-speed resistance and multicomponent training efficacy on strength in older women at risk of sarcopenia. A randomized clinical trial. Clin Nutr. 2025 Apr;47:103-111. doi: 10.1016/j.clnu.2025.02.015. Epub 2025 Feb 19.
PubMed 39999641Polo-Ferrero L, Saez-Gutierrez S, Davila-Marcos A, Barbero-Iglesias FJ, Sanchez-Sanchez MC, Puente-Gonzalez AS, Mendez-Sanchez R. Effect of power training on function and body composition in older women with probable sarcopenia. A study protocol for a randomized controlled trial. PLoS One. 2025 Jan 6;20(1):e0313072. doi: 10.1371/journal.pone.0313072. eCollection 2025.
PubMed 39761305
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Power Training Compared With Non-specific Exercises on Functionality and Body Composition in Women Older Than 65 Years With Probable Sarcopenia.
- ClinicalTrials.gov ID
- NCT05870046
- Acronym / sponsor ID
- POSARC / USalamancaPowerSarcopenia
- Conditions
- Pre-sarcopenia, Old Age; Debility
- Keywords
- exercise, elderly, resistance training, sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 23 May 2023 (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 is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of resistance training based on power training, multimodal exercise with non-specific exercises and a control group on functionality and body composition in women over 65 years of age with pre-sarcopenia.
The intervention in both groups will be carried out for 30 weeks, with three weekly sessions. Two evaluations will be performed, one pre-intervention and one post-intervention. Functionality (Timed Up \& Go test (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)) will be evaluated.
Detailed description
Design: Randomized, controlled clinical trial with three parallel groups, in which women over 65 years of age will be recruited. Study participants will be assigned to one of the three interventions. The study will have a duration of 8 months. There will be 2 evaluation visits, an initial one, a final one at 8 months. During 8 months there will be 3 weekly sessions lasting 50 minutes.
Scope: The study will be carried out in the Salamanca Health Area, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council.
Interventions: 1) Multimodal Exercise Group (GEM); 2) Muscle Power Exercise Group (GEP); 3) No Exercise Control Group (CG). The GEM and GEP sessions follow the same structural pattern. They will be structured according to the recommendations of the American College of Sports Medicine (ACSM). In the main part of the GEP, strength exercises will be performed and the speed will be progressively increased until the exercises are performed at the maximum speed that each participant can do.
Study population: 104 subjects over 65 years of age from the city of Salamanca will be included, distributed in 3 groups at a 1:1:1 ratio. Randomization will be performed using the Epidat 4.2 program. The sample size was calculated using GRANMO Version 7. 12 April 2012.
The main study variables are: Functionality (Timed Up \& Go test (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)), SARC-F Questionnaire, % RM estimated by force-velocity profile and Gait speed.
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables. Statistical analysis The effect of the intervention on the study variables if the variables are parametric, Student's t-test will be used, and if they are non-parametric, the Wilcoxon test will be used. An alpha risk of 0.05 is set as the limit of statistical significance. The statistical program to be used will be SPSS, v.26.0.
The study will be carried out with the authorization of the Ethics Committee on Drug Research (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. The participants will be informed of the objectives of the project and of the risks and benefits of the examinations and interventions to be performed. The study has been designed and subsequently assessed in accordance with Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Longitudinal prospective, controlled, single-blind study
| Arm | Type | Receives |
|---|---|---|
| power exercise group | Experimental | Procedure: Power training in women older than 65 years with pre-sarcopeniaThe main part of the muscle power exercise program will have the following exercises: wall push-ups, arm raises, elbow push-ups and extensions, weighted pronosupination, hand press, knee and hip hinge squat, dead weight, front and sagittal plan stride, and heel raises. It will have different phases: * 1st phase: exercise adaptation: the correct execution of upper and lower limb exercises will be taught for one month. * 2nd phase: Resistance training: During the following two months, strength exercises will be performed at slow and normal speed of the movement patterns learned in the training course. * 3rd phase: Muscle power training: During the last five months. A correct progression of the load and a progressive increase in the speed of execution of the different exercises will be carried out, gradually increasing the levels of difficulty and intensity. |
| multimodal exercise group | Active comparator | Procedure: Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopeniaThe main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises, playful activities or games are also included with some activities aimed at working on cognitive functions to reinforce the overall effects of the program, such as games with colors, numbers, letters, right-left laterality, memory, etc. The progression of the different models is as follows: * E. Aerobic: Start with continuous work, then intervallic, and decrease rest times in intervallic work. * E. Strength: Increase sets, repetitions and decrease rest time. * Balance: start with static and evolve with blindfolds, perturbations, dynamic balance, etc. * Coordination, and cognitive games will also become more complicated, with more complicated and faster decision making. |
| Control group | No intervention | –Participants in this group should continue with their usual dietary pattern and level of physical activity, without changing their lifestyle habits during the study period. They will not participate in the strength exercise program based on muscle power, nor will they perform systematic, programmed and supervised physical exercise in any other program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Women older than 65 years.
- pre-sarcopenia state (chair stand test > 15s or Hand Grip Strength < 16Kg).
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 |
|---|---|---|
| Power training in women older than 65 years with pre-sarcopeniaresistance training based on muscle power training, perform the exercises at high speed. | Procedure or surgery | power exercise group |
| Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopeniadifferent exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises. | Procedure or surgery | multimodal exercise group |
Primary outcome
Grip strength test
Time frame: thirty 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
Time frame: thirty 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
7 secondary outcomes
SARC-F questionnaire
Time frame: thirty weeks
Evaluation of changes in contraction velocity (m/s)
Time frame: thirty weeks
Body Mass Index (BMI)
Time frame: thirty weeks
Short Physical Performance Battery (SPPB)
Time frame: thirty weeks
Gait speed
Time frame: thirty weeks
Timed Up and Go (TUG)
Time frame: thirty weeks
food frequency questionnaire (FFQ)
Time frame: thirty 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 19 Mar 2025.
- Derived from this study: PubMed 39999641Polo-Ferrero L, Recio-Rodriguez JI, Gonzalez-Manzano S, Martin-Vallejo J, Barbero-Iglesias FJ, Montero-Errasquin B, Cruz-Jentoft AJ, Mendez-Sanchez R. Nutritional intake as a determinant of high-speed resistance and multicomponent training efficacy on strength in older women at risk of sarcopenia. A randomized clinical trial. Clin Nutr. 2025 Apr;47:103-111. doi: 10.1016/j.clnu.2025.02.015. Epub 2025 Feb 19.
- Derived from this study: PubMed 39761305Polo-Ferrero L, Saez-Gutierrez S, Davila-Marcos A, Barbero-Iglesias FJ, Sanchez-Sanchez MC, Puente-Gonzalez AS, Mendez-Sanchez R. Effect of power training on function and body composition in older women with probable sarcopenia. A study protocol for a randomized controlled trial. PLoS One. 2025 Jan 6;20(1):e0313072. doi: 10.1371/journal.pone.0313072. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power training in women older than 65 years with pre-sarcopenia and Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopenia in people with Pre-sarcopenia and Old Age; Debility, 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 19 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?
Grip strength test (time frame: thirty weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05870046, which also lists 2 linked publications.
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 19 Mar 2025.