An interventional study of Cluster Training plus Creatine Supplementation and Cluster Training plus placebo in Sarcopenia in Elderly, Creatine Supplementation and Resistance Exercise, sponsored by Dynamical Business and Science Society - DBSS International SAS. Completed at 1 site in Mexico. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Dynamical Business and Science Society - DBSS International SAS · Not applicable, Interventional, and Other
Resistance training (RT) is a widely used strategy to improve strength in older adults and counteract age-related decline. Combining RT with creatine monohydrate (CrM) supplementation has been shown to enhance exercise-induced improvements in muscle status and physical performance in this population. Cluster-set resistance training (CS-RT) is a relatively recent approach that has not yet been explored in combination with CrM supplementation in this population. Thus, this study aims to investigate the effects of an 8-week CS-RT program with and without CrM supplementation on body composition and physical performance in older adults. Thirty-six older adults over 60 years of age, with no prior RT experience, will be randomly assigned to one of three groups: CS-RT+CrM (n=12, 0.1 g·kg-¹·day-¹ of CrM), CS-RT without CrM supplementation (n=12), and a control group (CG) maintaining usual daily activities. The 8-week CS-RT program will include three sessions per week with 48 hours of rest between sessions. Each session will consist of three sets of 3 blocks × 4 repetitions at 75% of 1RM, with 30-second intra-set rest and 2-minute rest intervals between sets and exercises (lower limbs: half squat, leg extension, leg press, calf raise; upper limbs: chest press, lat pulldown, shoulder press, biceps/triceps curls). Concentric repetitions will be performed at maximal intended velocity. Body composition will be assessed using dual-energy X-ray absorptiometry (DXA), physical performance with the Short Physical Performance Battery (SPPB), and maximal strength using a one-repetition maximum (1RM) test following ACSM and NSCA guidelines. Statistical analysis will include an ANCOVA with pre-test scores as a covariate, followed by post hoc tests and effect size calculations. Additionally, a difference-in-differences estimation approach will be employed to assess changes over time, with statistical significance set at p \< 0.05. The investigators hypothesize that CS-RT+CrM will result in greater improvements on body composition (reduction of fat mass and increase of fat-free mass), physical performance, and maximal strength compared to CS-RT alone. This clinical trial was approved by the Academic Unit of the Postgraduate and Research Department of the Autonomous University of Baja California - Tijuana Campus, Mexico (Code: 340/4188).
This study aims to investigate the effects of an 8-week CS-RT program with and without CrM supplementation on body composition and physical performance in older adults.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Dynamical Business and Science Society - DBSS International SAS is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
In this arm, a strength training program will be implemented, combined with supplementation with creatine monohydrate.
Dietary Supplement: Cluster Training plus Creatine Supplementation
This group will only follow the strength training program and will consume a placebo.
Other: Cluster Training plus placebo
The 8-week CS-RT program will include three sessions per week with 48 hours of rest between sessions. Each session will consist of three sets of 3 blocks × 4 repetitions at 75% of 1RM, with 30-second intra-set rest and 2-minute rest intervals between sets and exercises (lower limbs: half squat, leg extension, leg press, calf raise; upper limbs: chest press, lat pulldown, shoulder press, biceps/triceps curls). Concentric repetitions will be performed at maximal intended velocity. CS-RT+CrM will be supplemented with 0.1 g·kg-¹·day-¹ of CrM.
Also known as: CS-RT + CrM
The 8-week CS-RT program will include three sessions per week with 48 hours of rest between sessions. Each session will consist of three sets of 3 blocks × 4 repetitions at 75% of 1RM, with 30-second intra-set rest and 2-minute rest intervals between sets and exercises (lower limbs: half squat, leg extension, leg press, calf raise; upper limbs: chest press, lat pulldown, shoulder press, biceps/triceps curls). Concentric repetitions will be performed at maximal intended velocity.
Also known as: CS-RT + Pbo
Stature in meters
Stature was measured using a stadiometer (SECA, model 213; Seca Corp., Hanover, MD, USA) with a measurement range of 20-205 cm and 1 mm increments. Participants were positioned standing, barefoot, with their heads oriented in the Frankfort plane
Time frame: From enrollment to the end of treatment at 8 weeks
Body mass in kilograms
Body mass was measured using an Omron bioelectrical impedance body composition monitor (model HBF-514C; Omron Healthcare, Inc., USA), which has a measurement range of 2-150 kg with 0.1 kg increments. Participants were instructed to stand upright and steady on the scale, looking straight ahead, with their arms extended at their sides.
Time frame: From enrollment to the end of treatment at 8 weeks
Body composition
Whole and regional body composition were estimated using dual-energy X-ray absorptiometry (DXA). Each subject was scanned by a certified technician, and the dis-tinguished bone and soft tissue, edge detection, and regional demarcations were per-formed by computer algorithms (software version enCORE™ 16.0, Lunar Prodigy Ad-vanced, GE Medical System Lunar, Madison, WI). The variables that will be taken into account are lean soft tissue in kilograms, fat-free mass in kilograms, body fat percentage, fat mass in kilograms, visceral adipose tissue in grams, bone mineral content in grams, and bone mineral density in grams per square centimeter.
Time frame: From enrollment to the end of treatment at 8 weeks
Timed Up & Go test in seconds to assess the risk of falling
It is used to assess fall risk and functional mobility in older adults. A chair without armrests, with a firm backrest and a seat height of approximately 46 centimeters, is used. A mark is placed three meters in front of the chair. The individual is asked to sit with their back against the backrest and their feet planted firmly on the floor. Upon the evaluator's signal, the patient must stand up from the chair as quickly and safely as possible, walk to the three-meter mark, turn around it, and return to the chair, sitting back down with their back against the backrest. Timing begins at the evaluator's signal and ends the moment the patient sits down.
Time frame: From enrollment to the end of treatment at 8 weeks
gait test in seconds
Assess walking speed. A four-meter path is marked out on a flat surface, free of obstacles. The patient is instructed to begin walking as quickly as possible upon a given signal. The time taken from the start to the four-meter mark is measured.
Time frame: From enrollment to the end of treatment at 8 weeks
Chair-stand test in seconds
Assess lower-limb strength. Use a sturdy chair without armrests. Ask the patient to sit with their arms crossed over their chest, then stand up and sit back down. Record the time taken to complete five full repetitions.
Time frame: From enrollment to the end of treatment at 8 weeks
Estimated maximum force in pounds
The Brzycki equation (Brzycki, 1993) will be used to estimate one-repetition maximum (1RM) strength for the following exercises: leg press, leg curl, leg extension, squat, bench press, and row. This formula is validated for predicting maximum strength in older adults, given its high correlation with direct 1RM measurement. The procedure will begin with a familiarization phase involving the equipment and exercises to be performed. Following a general warm-up, a specific warm-up will be conducted for each piece of equipment (8 to 10 repetitions at 40% of the perceived maximum weight). To estimate the 1RM, a weight representing approximately 75% of the perceived maximum will be selected; participants will perform repetitions at a controlled speed, with encouragement to complete as many repetitions as possible until reaching failure. The weight lifted and the number of correctly completed repetitions will be recorded and then entered into the formula developed by Brzycki: 1RM = weight lif
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: No
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Ran from Feb 2025 to primary completion in Jun 2025, 4 months.
Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 4 months is below that.
Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Dynamical Business and Science Society - DBSS International SAS