FrailtyELDERPLAYNCT07864831
Community-Based Multicomponent Exercise and Recreational Programme for Older Adults
A study testing ELDERPLAY multicomponent exercise and recreational programme in people with Frailty and Aging, run by Universidad de Murcia at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Aging, Physical Functional Performance
- What is being tested?
- ELDERPLAY multicomponent exercise and recreational programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 31 Dec 2023
- 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
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Individuals aged 65 years or older, of both sexes.
- Absence of cognitive deterioration or mild cognitive deterioration, as measured through the Pfeiffer Questionnaire (Pfeiffer score > 7 points).
- Conserved mobility: absence of incapacitating illnesses that impeded walking with or without support devices, such as a cane. The use of a walking aid such as a cane was not in itself an exclusion criterion; participants who walked with a cane were eligible.
Who cannot join
- Institutionalization in a nursing home.
- Regular participation in structured physical exercise outside the study programme (i.e., attending supervised exercise sessions more than twice a week).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Community facilities of the Municipality of Lorca
Lorca, Murcia, 30800
About this study
Official title: Physical Performance Outcomes and Programme Delivery Costs of ELDERPLAY, a Community-Based Multicomponent Exercise and Recreational Intervention for Older Adults: A Non-Randomized Controlled Evaluation
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.
Read the detailed description
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).
- Conditions
- Frailty, Aging, Physical Functional Performance, Postural Balance
- Being tested
- ELDERPLAY multicomponent exercise and recreational programme
- Keywords
- older adults, multicomponent exercise, traditional games, community-based programme, frailty prevention, Short Physical Performance Battery, Timed Up and Go, physical performance, programme costs
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELDERPLAY multicomponent exercise and recreational programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ELDERPLAY programme | Experimental | 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. Receives: Behavioral: ELDERPLAY multicomponent exercise and recreational programme |
| Control | No intervention | Usual daily activities. No structured exercise programme was provided by the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), week 5 (T1) and week 10 (T2)
Secondary outcomes (5)
Daily step count
Mean number of steps per day derived from wrist-worn actigraphy over seven consecutive days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through programme completion, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups recruited concurrently; allocation to the intervention or control group was determined by voluntary enrolment and by the participant's geographic area of residence, without randomization.
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Poncemar, MurciaSalud
- Responsible party
- Sponsor
- Investigators
- Alberto Salas-Cañizares, RN, MSc, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864831
- Sponsor's protocol ID
- ELDERPLAY-UMU-3992-2022
- Other IDs
- 3992/2022, CEI-2022-04-20
- Acronym
- ELDERPLAY
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Performance Outcomes and Programme Delivery Costs of ELDERPLAY, a Community-Based Multicomponent Exercise and Recreational Intervention for Older Adults: A Non-Randomized Controlled Evaluation
- ClinicalTrials.gov ID
- NCT07864831
- Acronym / sponsor ID
- ELDERPLAY / ELDERPLAY-UMU-3992-2022
- Conditions
- Frailty, Aging, Physical Functional Performance, Postural Balance
- Keywords
- older adults, multicomponent exercise, traditional games, community-based programme, frailty prevention, Short Physical Performance Battery, Timed Up and Go, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Collaborators
- Fundación Poncemar, MurciaSalud
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Oct 2026 (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 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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups recruited concurrently; allocation to the intervention or control group was determined by voluntary enrolment and by the participant's geographic area of residence, without randomization.
| Arm | Type | Receives |
|---|---|---|
| ELDERPLAY programme | Experimental | Behavioral: ELDERPLAY multicomponent exercise and recreational programmeTwenty 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. |
| Control | No intervention | –Usual daily activities. No structured exercise programme was provided by the study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Individuals aged 65 years or older, of both sexes.
- Absence of cognitive deterioration or mild cognitive deterioration, as measured through the Pfeiffer Questionnaire (Pfeiffer score > 7 points).
- Conserved mobility: absence of incapacitating illnesses that impeded walking with or without support devices, such as a cane. The use of a walking aid such as a cane was not in itself an exclusion criterion; participants who walked with a cane were eligible.
Key exclusion criteria (2 listed)
- Institutionalization in a nursing home.
- Regular participation in structured physical exercise outside the study programme (i.e., attending supervised exercise sessions more than twice a week).
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 |
|---|---|---|
| ELDERPLAY multicomponent exercise and recreational programmeMulticomponent 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. | Behavioural | ELDERPLAY programme |
Primary outcome
Short Physical Performance Battery (SPPB) total score
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
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.
SPPB balance component
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
Ability to hold the feet-together, semi-tandem and tandem stands, assessed as part of the Short Physical Performance Battery.
SPPB gait performance
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
Time in seconds to walk 4 metres at usual pace, assessed as part of the Short Physical Performance Battery. Shorter times indicate better performance.
SPPB chair-stand performance
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
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.
Timed Up and Go test
Time frame: Baseline (T0), week 5 (T1) and week 10 (T2)
Time in seconds to rise from a chair, walk 3 metres, turn, walk back and sit down again. Shorter times indicate better functional mobility.
5 secondary outcomes
Daily step count
Time frame: Week 5 (T1), over seven consecutive days
Heart rate parameters
Time frame: Week 5 (T1), over seven consecutive days
Actigraphy-derived sleep parameters
Time frame: Week 5 (T1), over seven consecutive days
Sleep quality (Pittsburgh Sleep Quality Index)
Time frame: Week 5 (T1)
Programme delivery cost per participant
Time frame: Through programme completion, 10 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 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
Alberto Salas-Cañizares, RN, MSc principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELDERPLAY multicomponent exercise and recreational programme in people with Frailty and Aging, run by Universidad de Murcia 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 3 inclusion and 2 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 8 Oct 2026. 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?
Short Physical Performance Battery (SPPB) total score (time frame: Baseline (T0), week 5 (T1) and week 10 (T2)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.