Authors
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Universidad Andrés Bello -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2026
INTERVENTION: An exploratory pilot experimental study with repeated within‐subject measures and a mixed quantitative‐qualitative approach will be conducted in 30 healthy young adults aged 18 to 30 years, selected through non‐probability convenience sampling; the quantitative component will assess protocol feasibility, muscle performance, and exercise‐induced hypoalgesia, while the qualitative component will explore participants’ perceptions of the experience; all participants will perform a dynamometric five‐repetition sit‐to‐stand test under four conditions: no feedback, human feedback, technological feedback, and combined feedback, with each participant acting as their own control; the order of the conditions will be randomized using sequences generated in Microsoft Excel by a researcher who will not be directly involved in recruitment, and allocation will be concealed in opaque, sealed, sequentially numbered envelopes; the protocol does not report masking; two individual sessions and one group session will be conducted; during the first individual session, general characteristics will be recorded and participants will be familiarized with the test, equipment, and four conditions; after five minutes of light cycling and five minutes of active mobility exercises, each participant will practice two sets of five repetitions per condition, one submaximal and one maximal, with two minutes of rest between sets; during the second individual session, pressure pain threshold will initially be measured, followed by performance of the four conditions; the test will be performed using a Myoquality M1 functional electromechanical dynamometer, a 0.45‐meter chair, and an individualized load that will progressively increase from 10 percent of body weight in the first repetition to 40 percent in the fifth; under each condition, two sets of five repetitions will be performed, with two minutes of rest between sets and ten minutes between conditions; each repetition will begin at three‐second intervals; the no‐feedback condition will not include auditory or visual cues; the human feedback condition will be guided by an instructor using the cues ready, set, and go; the technological feedback condition will use visual and auditory cues delivered through a HyperText Markup Language (HTML) application; the combined feedback condition will simultaneously integrate both modalities; pressure pain threshold will be reassessed after each condition; at the end of the second session, visual analogue scales assessing ease, motivation, and satisfaction, as well as an individual qualitative interview, will be administered; subsequently, after completion of the individual sessions, a third group session will be conducted by videoconference, consisting of a focus group aimed at exploring in greater depth participants’ perceptions of their experience under the different conditions CONDITION: Healthy Volunteers ; Young Adult M01.060.116.815 PRIMARY OUTCOME: The pilot experimental protocol is expected to be feasible, assessed through recruitment, retention, adaptation, compliance, and safety indicators; the feasibility criteria will be recruitment equal to or greater than 50%, retention equal to or greater than 80%, adaptation equal to or greater than 80%, compliance equal to or greater than 80%, and safety of 100%; the protocol will be considered feasible if at least four of the five indicators meet the established criterion, necessarily including the safety indicator SECONDARY OUTCOME: A favorable subjective perception regarding ease, motivation, and satisfaction during performance of the test under the different conditions is expected, assessed using 100‐mm visual analogue scales after completion of all tests; a mean score equal to or greater than 60 mm in each dimension will be considered favorable A trend toward greater exercise‐induced hypoalgesia is expected in the combined feedback condition compared with the other conditions, assessed through the change in pressure pain threshold between the baseline measurement and the measurement obtained immediately after each condition, using digital algometry at the upper trapezius, thigh, and lumbar spine on the dominant side of the body; positive changes will indicate an increase in pressure pain threshold and a response compatible with hypoalgesia A trend toward greater muscle performance is expected in the combined feedback condition compared with the other conditions, assessed using functional electromechanical dynamometry during the five‐repetition sit‐to‐stand test, considering maximal and mean force in newtons (N), maximal and mean power in watts (W), maximal and mean velocity in meters per second (m/s), and work in joules (J) Participants are expected to perceive performance of the test under the different conditions as understandable, safe, and acceptable, and to identify facilitators, barriers, and recommendations for improvement; this perception will be assessed through an individual semi‐structured qualitative interview and a focus group conducted by videoconference, whose discourse will be analyzed using inductive coding and categorization and intersubjective triangulation among researchers INCLUSION CRITERIA: Individuals of both sexes; age between 18 and 30 years; absence of uncontrolled or symptomatic musculoskeletal, cardiovascular, or neurological diseases or conditions, or conditions that cause pain, functional limitation, medical restriction, or risk when performing functional lower‐limb tasks involving physical exertion
Epistemonikos ID: 760cc573acddb50ff6014d6ab576af8942c48bed
First added on: Oct 08, 2026