- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494916
Effects of Functional Task Training on Muscle Health and Function in Older Adults With Sarcopenia
Effect of Functional Task Training (FTT) on Functional, Physiological, and Structural Biomarkers in Older Adults With Sarcopenia
Sarcopenia is a condition associated with aging that causes a loss of muscle mass, strength, and physical function. This decline limits the ability to perform basic daily activities and increases the risk of falls and dependency.
The purpose of this clinical study is to determine the effects of a 12-week Functional Task Training (FTT) program on functional, structural, and physiological biomarkers in older adults with sarcopenia. FTT involves practicing everyday movements, such as standing up from a chair, climbing stairs, walking, and carrying objects.
The study aims to answer the following question: Does Functional Task Training performed specifically in optimal muscle power zones offer greater improvements in aging biomarkers compared to standard Functional Task Training or traditional resistance training?
The researchers hypothesize that while all exercise interventions will be beneficial, the FTT program focused on power zones will generate the greatest improvements in functional, physiological, and structural biomarkers in older adults with sarcopenia.
To test this, 30 older adults (aged 60 and older) will be randomly assigned to one of three active groups for a 12-week period (2 days per week): an FTT group training in power zones, a standard FTT group, or a traditional resistance training group. All exercise groups will use a Functional Electromechanical Dynamometer (DEMF) to precisely measure and control the training loads.
Study Overview
Status
Detailed Description
Population aging is a major public health challenge associated with a progressive decline in muscle function and functional capacity. Sarcopenia, characterized by age-related loss of muscle mass, strength, and function, increases the risk of falls, dependency, and mortality. Among muscular determinants, muscle power has been shown to be highly relevant for executing daily tasks and preventing falls.
In this context, Functional Task Training (FTT) has emerged as a promising strategy to improve muscle quality and functionality by simulating daily activities. Furthermore, the use of a Functional Electromechanical Dynamometer (DEMF) allows for precise load adjustment, replicating natural movements with controlled resistance, and providing accurate measurements of applied force, velocity, and power. Despite these advances, there is a gap in the literature regarding the specific impact of FTT-and particularly FTT executed in optimal power zones-on functional, physiological, and structural biomarkers in older populations.
This randomized controlled trial aims to evaluate these effects over a 12-week period in a sample of 30 older adults with sarcopenia.
Study Procedures and Progression:
Following initial screening and prior to baseline testing, participants will undergo two familiarization sessions to ensure safety and proper technique. During the 12-week intervention phase, participants will be randomized into one of three active training arms: FTT in Power Zones, Standard FTT, or Traditional Resistance Training (RT). All groups will attend supervised sessions 2 days per week.
A key methodological component of this study is the integration of the DEMF device across all three groups, which ensures electronic and progressive load adjustments. During the first session, the initial load will be determined through individual testing. Throughout the program, loads will be progressively increased on a weekly basis by 5% to 10%, depending on the individual's tolerance, performance, and specific group assignment (e.g., specific velocity and power targets for the FTT Power Zone group).
At the end of the 12-week intervention, all participants will undergo post-intervention assessments in the laboratory using the same instruments and standardized conditions to ensure consistency in the results.
Statistical Analysis:
Data normality will be evaluated using the Shapiro-Wilk test, and homogeneity of variance will be assessed with Levene's test. Repeated measures analysis of variance (Two-way ANOVA) will be used to evaluate intra- and inter-group changes, followed by a Tukey post hoc test if significant differences are found.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Granada
-
Granada, Granada, Spain, 18006
- Lab. IDAFISAD CTS 642 Faculty of Sports Science, Granada
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants aged 60 years or older.
Diagnosis of probable or confirmed sarcopenia (according to EWGSOP2 criteria, including low handgrip strength and/or low muscle mass).
Ability to walk independently (with or without assistive devices).
Medically cleared to participate in a structured physical exercise program.
Voluntary participation and signed informed consent.
Exclusion Criteria:
Unstable cardiovascular disease, uncontrolled hypertension, or any medical condition where exercise is contraindicated.
Recent bone fractures or major surgeries within the last 6 months that limit physical activity.
Severe visual or auditory deficits that interfere with the training sessions.
Concurrent participation in another structured resistance training or functional exercise program.
Any musculoskeletal or neurological condition that prevents the safe use of the Functional Electromechanical Dynamometer (DEMF)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FTT in Power Zones
Participants assigned to this experimental arm will undergo a 12-week Functional Task Training (FTT) program, 2 days per week.
The intervention involves exercises simulating activities of daily living, such as sitting and standing from a chair, stair climbing, walking with directional changes, and lifting objects.
Crucially, exercises will be performed using a Functional Electromechanical Dynamometer (DEMF) to ensure participants train specifically within their optimal muscle power zones.
Execution velocity will be continuously monitored to electronically adjust loads based on individual power performance.
|
Participants will perform a 12-week Functional Task Training (FTT) program (2 sessions/week, 60 min/session). The circuit includes 4 specific functional tasks designed to simulate daily life demands: 1) Sit-to-stand from a chair, 2) Walking with changes of direction, 3) Lifting and carrying objects, and 4) Pulling/pushing movements. All exercises will be executed using a Functional Electromechanical Dynamometer (DEMF). This device provides constant electronic resistance and allows for the determination of the individual load that elicits peak power output. Training intensity will be strictly monitored to ensure participants perform each repetition within their optimal muscle power zone. Loads will be adjusted progressively (5-10% weekly) based on the velocity and power data provided by the device. Each session includes a warm-up, 3 sets of 10-12 repetitions per task, and a cool-down. |
|
Experimental: Standard Functional Task Training (FTT)
Participants assigned to this experimental arm will undergo a 12-week Functional Task Training (FTT) program, 2 days per week.
The intervention consists of exercises simulating activities of daily living, including sit-to-stand, stair climbing, walking, and lifting objects.
Exercises will be performed using the DEMF device following standard progressive load adjustments based on tolerance and performance, without specifically targeting optimal muscle power zones.
|
Participants will perform a 12-week Functional Task Training (FTT) program (2 sessions/week, 60 min/session).
The circuit includes 4 specific functional tasks: 1) Sit-to-stand from a chair, 2) Walking with changes of direction, 3) Lifting and carrying objects, and 4) Pulling/pushing movements.
All exercises will be executed using the Functional Electromechanical Dynamometer (DEMF).
Training follows standard progressive resistance protocols (5-10% weekly load increase) based on individual tolerance, without specifically targeting or monitoring the optimal muscle power zones.
|
|
Active Comparator: Traditional Resistance Training (RT)
Participants assigned to this active comparator arm will complete a 12-week traditional resistance training program, 2 days per week.
The protocol targets major muscle groups through conventional exercises (e.g., leg press, bench press).
These exercises will also be performed using the DEMF device to control and monitor the training loads, but the focus will remain on traditional strength parameters rather than specific functional tasks or optimal power zones.
|
Participants will complete a 12-week traditional resistance training program (2 sessions/week, 60 min/session).
The protocol targets major muscle groups through 4 conventional analytical exercises (e.g., leg press, chest press, row, and leg extension).
These exercises will be performed using the DEMF device to control and monitor the training loads.
This group does not perform functional task simulations or power-zone specific training, following a standard hypertrophy and strength progression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Thickness of the Rectus Femoris
Time Frame: Baseline and 12 weeks
|
Muscle thickness will be measured in centimeters (cm) using B-mode ultrasound.
The assessment will be performed at the midpoint between the anterior superior iliac spine and the superior border of the patella.
This measurement serves as a structural biomarker to evaluate changes in muscle mass.
Higher values indicate an increase in muscle volume
|
Baseline and 12 weeks
|
|
Muscle Thickness of the Rectus Femoris (via Ultrasound)
Time Frame: Baseline and 12 weeks
|
Evaluation of muscle structural changes using B-mode ultrasound.
The thickness (measured in centimeters) of the rectus femoris muscle will be assessed at the midpoint between the anterior superior iliac spine and the superior border of the patella.
This measurement serves as a structural biomarker for muscle mass.
Higher values indicate an increase in muscle volume and a reduction in sarcopenia-related atrophy.
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5310/CEIH/2025-FTT
- A.SEJ.227.UGR23 (Other Grant/Funding Number: Consejería de Universidad, Investigación e Innovación / Programa FEDER Andalucía)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcopenia
-
University Hospital, BonnRecruiting
-
Cairo UniversityNot yet recruitingGeriatric SarcopeniaEgypt
-
Shanghai Yueyang Integrated Medicine HospitalShanghai University of Traditional Chinese Medicine; DongE E Jiao Coporation... and other collaboratorsNot yet recruiting
-
TNF Pharmaceuticals, Inc.Not yet recruitingFrailty | Sarcopenia in Elderly | Frailty/Sarcopenia | Frailty in Older Adults
-
Assiut UniversityNot yet recruiting
-
University of ExtremaduraCompletedSarcopenia in Elderly | Institutionalized Older Adults | HIITSpain
-
Medway NHS Foundation TrustNot yet recruitingFalls | Sarcopenia in ElderlyUnited Kingdom
-
University of Texas at AustinNot yet recruitingExercise Training and SarcopeniaUnited States
-
Animuscure Inc.Recruiting
-
West China HospitalNot yet recruitingSarcopenia in Elderly
Clinical Trials on Functional Task Training in Power Zones
-
Amsterdam UMC, location VUmcUniversity Ghent; Reade Rheumatology Research InstituteRecruitingCerebral Palsy, SpasticNetherlands
-
Geriatric Education and Research InstituteCompletedMuscle Weakness | FrailtySingapore
-
Cairo UniversityCompletedCerebral Palsy Spastic DiplegiaEgypt
-
Riphah International UniversityCompletedCerebral PalsyPakistan
-
Foundation University IslamabadEnrolling by invitation
-
University of ConnecticutEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingCerebral Palsy | Hemiplegia | Children, OnlyUnited States
-
Universidad del RosarioCORPORACION HOSPITALARIA JUAN CIUDAD, MEDERIWithdrawnOsteoarthritis, HipColombia
-
Riphah International UniversityCompletedCerebral PalsyPakistan
-
Istanbul University - CerrahpasaRecruitingPediatric-Onset Multiple Sclerosis (POMS)Turkey (Türkiye)
-
Centre for Interdisciplinary Research in Rehabilitation...Mitacs; Neuro-Concept Inc.RecruitingSpinal Cord InjuriesCanada