An interventional study of ELDERPLAY multicomponent exercise and recreational programme in Frailty, Aging and Physical Functional Performance, sponsored by Universidad de Murcia. Completed at 1 site in Spain. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Universidad de Murcia · Not applicable, Interventional, and Prevention
This quasi-experimental, non-randomized controlled evaluation examined whether participation in ELDERPLAY, a community-based programme combining Vivifrail-based multicomponent exercise with adapted traditional games, was associated with changes in physical performance and frailty-related function in community-dwelling adults aged 65 years and older, and estimated the cost of delivering the programme.
Participants were allocated to the intervention group or to a concurrent control group through voluntary enrolment and geographic matching, without randomization. The intervention consisted of 20 supervised group sessions, two per week over ten weeks. Physical performance was assessed with the Short Physical Performance Battery and the Timed Up and Go test at baseline, at week 5 and at week 10. Secondary exploratory outcomes included actigraphy-derived daily step count, heart rate and sleep parameters, recorded over seven consecutive days at a single intermediate assessment point, and sleep quality assessed with the Pittsburgh Sleep Quality Index.
Programme delivery costs were estimated from the perspective of the programme provider using an activity-based costing approach. Because allocation was not randomized and the groups differed at baseline, the findings are associative and do not support causal inference.
Recruitment was carried out in collaboration with community organizations and a federation of neighbourhood associations in the municipality of Lorca (Region of Murcia, Spain), between July 2022 and December 2023. Allocation was based on voluntary enrolment and on the geographic area of residence, with both groups recruited concurrently. Outcome assessment was not blinded to group allocation: all assessments were administered by a single assessor who was also responsible for delivering the intervention.
Statistical analysis used two-way analyses of covariance for the quantitative outcomes and generalized estimating equations for the dichotomous balance items, adjusted for the baseline variables that differed significantly between groups (cholesterol, COVID-19 vaccination and Barthel Index score).
1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.
This study's enrollment of 184 is above the median of 80 across 704 interventional studies indexed under Frailty.
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Exclusion Criteria:
Twenty supervised group sessions, two per week over ten weeks, combining Vivifrail-based multicomponent exercise (strength, balance, gait and flexibility) with traditional games adapted to the functional level of the participants.
Behavioral: ELDERPLAY multicomponent exercise and recreational programme
Usual daily activities. No structured exercise programme was provided by the study
Multicomponent exercise based on the Vivifrail programme (strength, balance, gait and flexibility training) combined with adapted traditional games, delivered in supervised group sessions of approximately 60 minutes, twice weekly for ten weeks, in community facilities.
Short Physical Performance Battery (SPPB) total score
Total score of the Short Physical Performance Battery, ranging from 0 to 12 points, combining the balance, gait and chair-stand components. Higher scores indicate better lower-extremity physical performance.
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
SPPB balance component
Ability to hold the feet-together, semi-tandem and tandem stands, assessed as part of the Short Physical Performance Battery.
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
SPPB gait performance
Time in seconds to walk 4 metres at usual pace, assessed as part of the Short Physical Performance Battery. Shorter times indicate better performance.
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
SPPB chair-stand performance
Time in seconds to complete five sit-to-stand repetitions from a chair without using the arms, assessed as part of the Short Physical Performance Battery. Shorter times indicate better performance.
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
Timed Up and Go test
Time in seconds to rise from a chair, walk 3 metres, turn, walk back and sit down again. Shorter times indicate better functional mobility.
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
Daily step count
Mean number of steps per day derived from wrist-worn actigraphy over seven consecutive days.
Time frame: Week 5 (T1), over seven consecutive days
Heart rate parameters
Mean, maximum and minimum heart rate in beats per minute derived from wrist-worn actigraphy over seven consecutive days.
Time frame: Week 5 (T1), over seven consecutive days
Actigraphy-derived sleep parameters
Total sleep time and time in light, deep and REM sleep, and nap time, in minutes, derived from wrist-worn actigraphy over seven consecutive days. These measures are exploratory: consumer-grade wrist-worn devices show limited agreement with polysomnography for sleep-stage classification.
Time frame: Week 5 (T1), over seven consecutive days
Sleep quality (Pittsburgh Sleep Quality Index)
Global score of the Pittsburgh Sleep Quality Index, ranging from 0 to 21 points. Scores above 5 indicate poor sleep quality.
Time frame: Week 5 (T1)
Programme delivery cost per participant
Direct cost of delivering the programme per participant, in 2023 euros, estimated using an activity-based costing approach from the perspective of the programme provider, including personnel, transport, facility rental, wearable devices and consumables.
Time frame: Through programme completion, 10 weeks
Plan to share: Yes — De-identified individual participant data underlying the results reported in this study, including physical performance measures (Short Physical Performance Battery and Timed Up and Go), actigraphy-derived variables and baseline sociodemographic and clinical characteristics, are available on reasonable request from the corresponding author. Access is subject to privacy restrictions concerning participant confidentiality.
Time frame: Beginning after publication of the main results, with no planned end date
Access criteria: Requests should be addressed to the corresponding author and will be assessed by the research team. Data will be shared with researchers who provide a methodologically sound proposal, subject to approval by the sponsor and to compliance with Spanish and European data protection legislation
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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 ↗
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