Frail ElderlyNCT07205016
FreeFrail Project: A Multicomponent Intervention for the Management of Frailty in Primary Care: A Randomized Controlled Trial
A study testing Dual task exercise and Otago exercise in people with Frail Elderly and Dual Task Exercises in Elderly People, run by Universitat de Lleida.
Trial summary
The primary aim is to assess the effectiveness of a multicomponent intervention including dual-task exercise in improving functionality and cognitive performance and in reducing frailty among community-dwelling adults aged ≥65 years compared to usual care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly, Dual Task Exercises in Elderly People, Exercise Training
- What is being tested?
- Dual task exercise and Otago exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 or older
- Frailty according to Fragil-VIG index (>0,20)
- Barthel index > 60
- Able to perform physical exercise
- Able to understand and communicate in Catalan or Spanish
Who cannot join
- Decompensated / Unstable cardiovascular disease or recent diagnosed
- Upper or lower injury with functional impairment
- Institutionalized patient.
- Terminal or tumoral processes
- People who participated in another clinical trial or exercise programme during last year
- Diagnosis of severe dementia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: FreeFrail Project: Effectiveness of a Multicomponent Intervention Including Dual-task Exercise to Increase Functionality and Cognitive Performance in Frail and Pre-frail Individuals Over 65 Years Aged in Primary Care Compared to Usual Care: Protocol for a Randomized Controlled Trial
The primary aim is to assess the effectiveness of a multicomponent intervention including dual-task exercise in improving functionality and cognitive performance and in reducing frailty among community-dwelling adults aged ≥65 years compared to usual care. Secondary objectives include evaluating its impact on pain, anxiety or depression, sleep quality, quality of life, physical activity, handgrip strength, and polypharmacy.
A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida. Frail older adults (≥65 years) will be recruited and randomly allocated to either the intervention group, receiving a structured cognitive-motor dual-task based multicomponent program, or the control group, receiving usual care. Outcomes will be assessed using validated tools at baseline and follow-up.
- Being tested
- Dual task exercise, Otago exercise
- Keywords
- primary care Health [MeSH], multicomponent intervention, exercise therapy [MeSH], cognitive-motor dual-task, frail elderly [MeSH], frailty [MeSH]
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task exerciseBehavioural
The intervention group will conduct the same multicomponent intervention than the control group, but adding the dual cognitive task while performing the therapeutic physical activity, which may include counting numbers backwards, in 2s, mentioning names of animals, food, countries and others. The objective of this additional condition is to stimulate cognitive and functional capacity simultaneously, increasing the complexity of the activity and the transfer to daily life activities.
Otago exerciseBehavioural
The proposed intervention is a multicomponent program designed to address frailty in community-dwelling older adults. It integrates three evidence-based domains: therapeutic physical activity, cognitive psychological intervention, and nutritional support.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The intervention group will conduct the same multicomponent intervention than the control group, but adding the dual cognitive task while performing the therapeutic physical activity, which may include counting numbers backwards, in 2s, mentioning names of animals, food, countries and others. The objective of this additional condition is to stimulate cognitive and functional capacity simultaneously, increasing the complexity of the activity and the transfer to daily life activities Receives: Behavioral: Dual task exercise |
| Control | Active comparator | A multicomponent program designed to address frailty in community-dwelling older adults. It integrates three evidence-based domains: therapeutic physical activity, cognitive psychological intervention, and nutritional support.
The three components are delivered in a coordinated manner by a multidisciplinary team at ICS. Intervention fidelity is ensured through standardized protocols, training of professionals, and monitoring of adherence.
The therapeutic physical activity program will be structured across three progressive levels-beginner, intermediate, and advanced-to accommodate varying functional capacities. Strength training will advance through incremental increases in repetitions and resistance, while balance exercises will become more challenging by reducing external support. The material for the session will be in the same room where the group is held and will include the use of weights or dumbbells, elastic bands, balls, and pikes Receives: Behavioral: Otago exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance and functional status
The Short Physical Performance Battery (SPPB) is an ordinal quantitative scale ranging from 0 to 12. This validated tool assesses three functional domains: lower-limb muscle strength, by timing the repeated chair-stand test; gait speed, through the 4-meter walking test; and static balance, evaluated with three progressively difficult positions (feet together, semi-tandem, tandem). A composite score is calculated, with lower values reflecting poorer performance. A score of 9 or less has been widely adopted as a cut-off point for identifying frailty and pre-frailty in older adults, making this instrument particularly suitable for evaluating the effectiveness of interventions on physical function
Measured: From enrollment to the end of treatment at 12 weeks
Cognitive function
The Mini-Mental State Examination (MMSE) is a continuous quantitative widely used 30-point screening tool validated for older adults to assess global cognitive function. It evaluates orientation, memory, attention, language, and praxis, providing a standardized quantitative measure of cognitive status. Although limited in sensitivity for mild or executive deficits, the MMSE remains a practical first-line assessment in frailty research and clinical protocols, and its integration alongside multidimensional frailty measures allows for a more comprehensive characterization of cognitive vulnerability in aging. A culturally adapted and validated version is available in Spanish, enabling its use in Hispanic populations.
Measured: From enrollment to the end of treatment at 12 weeks
Frailty status
The Frailty-VIG is an ordinal quantitative measure specifically validated for older adults in the community. This multidimensional tool comprises 22 dichotomous items spanning activities of daily living, nutrition, cognition, emotional health, social context, geriatric syndromes, and chronic diseases. By incorporating multimorbidity and psychosocial domains alongside physical aspects, the Frailty-VIG provides a comprehensive assessment of frailty, overcoming the limitations of purely physical indices
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
Quality of life / Anxiety and Depression / Pain severity
will be evaluated with the EuroQoL-5D-5L which generates ordinal categorical variables from five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-point Likert scale, where higher scores denote lower quality of life. This standardized and validated instrument has been extensively applied in Spanish populations and is particularly appropriate to capture the multidimensional impact of frailty on health-related quality of life
Measured: From enrollment to the end of treatment at 12 weeks
Sleep performance
will be assessed using the Spanish validated version of the Pittsburgh Sleep Quality Index (PSQI). This self-administered questionnaire yields a global score between 0 and 21, with higher scores reflecting worse sleep quality. It evaluates seven components-subjective quality, latency, duration, habitual efficiency, disturbances, medication use, and daytime dysfunction. A score above 5 is commonly considered indicative of clinically relevant sleep impairment. As poor sleep has been consistently associated with frailty and functional decline, the PSQI offers a sensitive and appropriate measure for this study
Measured: From enrollment to the end of treatment at 12 weeks
Physical activity
will be assessed through the International Physical Activity Questionnaire (IPAQ), which produces continuous quantitative data expressed in metabolic equivalent task minutes per week (MET-min/week). It includes seven open questions regarding activity over the previous seven days, covering walking, moderate and vigorous activities, and sedentary behaviour. The calculation of MET-min/week allows standardized estimation of global activity levels. This questionnaire is validated and widely used in community-dwelling adults, making it an appropriate measure for capturing the impact of the intervention on activity levels
Measured: From enrollment to the end of treatment at 12 weeks
Handgrip strength
will be measured with a handheld dynamometer. Results are expressed as continuous quantitative variables in kilograms. Following standardized protocols, participants will be seated with the elbow flexed at 90° and the wrist positioned between neutral and 30° dorsiflexion. They will be instructed to squeeze the dynamometer maximally for 3-5 seconds. Three trials will be performed alternately in each hand, with one-minute rest intervals, and the best value will be recorded. Handgrip strength is a simple, reliable, and validated marker of sarcopenia and frailty risk, strongly correlated with morbidity and mortality in older adults
Measured: From enrollment to the end of treatment at 12 weeks
Inflammatory and mitochondrial function biomarkers
are strongly supported by the literature in frail population, as these biological factors are fundamentally implicated in the pathways leading to frailty, sarcopenia, and functional impairment. Chronic low-grade inflammation ("inflammaging"), a hallmark of aging, is characterized by increased levels of circulating pro-inflammatory cytokines such as interleukin 6 and 8(IL-6, IL-8), interleukin 1β (IL-1β), tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP). These biomarkers consistently correlate with chronic low-grade inflammation ("inflammaging") and mitochondrial dysfunction (3) they have also been consistently associated with sarcopenia, frailty, and functional decline (4,5) . The blood samples will be analysed at Biomedical Research Institute of Lleida (IRB Lleida), generating continuous quantitative data.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut
- Responsible party
- Principal investigator, Oriol Martínez Navarro, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205016
- Sponsor's protocol ID
- FreeFrail Project
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FreeFrail Project: Effectiveness of a Multicomponent Intervention Including Dual-task Exercise to Increase Functionality and Cognitive Performance in Frail and Pre-frail Individuals Over 65 Years Aged in Primary Care Compared to Usual Care: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07205016
- Acronym / sponsor ID
- FreeFrail Project
- Keywords
- primary care Health [MeSH], multicomponent intervention, exercise therapy [MeSH], cognitive-motor dual-task, frail elderly [MeSH], frailty [MeSH]
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Collaborators
- Institut Catala de Salut
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Oct 2025 (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.
The primary aim is to assess the effectiveness of a multicomponent intervention including dual-task exercise in improving functionality and cognitive performance and in reducing frailty among community-dwelling adults aged ≥65 years compared to usual care. Secondary objectives include evaluating its impact on pain, anxiety or depression, sleep quality, quality of life, physical activity, handgrip strength, and polypharmacy.
A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida. Frail older adults (≥65 years) will be recruited and randomly allocated to either the intervention group, receiving a structured cognitive-motor dual-task based multicomponent program, or the control group, receiving usual care. Outcomes will be assessed using validated tools at baseline and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Dual task exerciseThe intervention group will conduct the same multicomponent intervention than the control group, but adding the dual cognitive task while performing the therapeutic physical activity, which may include counting numbers backwards, in 2s, mentioning names of animals, food, countries and others. The objective of this additional condition is to stimulate cognitive and functional capacity simultaneously, increasing the complexity of the activity and the transfer to daily life activities |
| Control | Active comparator | Behavioral: Otago exerciseA multicomponent program designed to address frailty in community-dwelling older adults. It integrates three evidence-based domains: therapeutic physical activity, cognitive psychological intervention, and nutritional support. The three components are delivered in a coordinated manner by a multidisciplinary team at ICS. Intervention fidelity is ensured through standardized protocols, training of professionals, and monitoring of adherence. The therapeutic physical activity program will be structured across three progressive levels-beginner, intermediate, and advanced-to accommodate varying functional capacities. Strength training will advance through incremental increases in repetitions and resistance, while balance exercises will become more challenging by reducing external support. The material for the session will be in the same room where the group is held and will include the use of weights or dumbbells, elastic bands, balls, and pikes |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged 65 or older
- Frailty according to Fragil-VIG index (>0,20)
- Barthel index > 60
- Able to perform physical exercise
- Able to understand and communicate in Catalan or Spanish
Key exclusion criteria (6 listed)
- Decompensated / Unstable cardiovascular disease or recent diagnosed
- Upper or lower injury with functional impairment
- Institutionalized patient.
- Terminal or tumoral processes
- People who participated in another clinical trial or exercise programme during last year
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 |
|---|---|---|
| Dual task exerciseThe intervention group will conduct the same multicomponent intervention than the control group, but adding the dual cognitive task while performing the therapeutic physical activity, which may include counting numbers backwards, in 2s, mentioning names of animals, food, countries and others. The objective of this additional condition is to stimulate cognitive and functional capacity simultaneously, increasing the complexity of the activity and the transfer to daily life activities. | Behavioural | Experimental |
| Otago exerciseThe proposed intervention is a multicomponent program designed to address frailty in community-dwelling older adults. It integrates three evidence-based domains: therapeutic physical activity, cognitive psychological intervention, and nutritional support. | Behavioural | Control |
Primary outcome
Physical performance and functional status
Time frame: From enrollment to the end of treatment at 12 weeks
The Short Physical Performance Battery (SPPB) is an ordinal quantitative scale ranging from 0 to 12. This validated tool assesses three functional domains: lower-limb muscle strength, by timing the repeated chair-stand test; gait speed, through the 4-meter walking test; and static balance, evaluated with three progressively difficult positions (feet together, semi-tandem, tandem). A composite score is calculated, with lower values reflecting poorer performance. A score of 9 or less has been widely adopted as a cut-off point for identifying frailty and pre-frailty in older adults, making this instrument particularly suitable for evaluating the effectiveness of interventions on physical function
Cognitive function
Time frame: From enrollment to the end of treatment at 12 weeks
The Mini-Mental State Examination (MMSE) is a continuous quantitative widely used 30-point screening tool validated for older adults to assess global cognitive function. It evaluates orientation, memory, attention, language, and praxis, providing a standardized quantitative measure of cognitive status. Although limited in sensitivity for mild or executive deficits, the MMSE remains a practical first-line assessment in frailty research and clinical protocols, and its integration alongside multidimensional frailty measures allows for a more comprehensive characterization of cognitive vulnerability in aging. A culturally adapted and validated version is available in Spanish, enabling its use in Hispanic populations.
Frailty status
Time frame: From enrollment to the end of treatment at 12 weeks
The Frailty-VIG is an ordinal quantitative measure specifically validated for older adults in the community. This multidimensional tool comprises 22 dichotomous items spanning activities of daily living, nutrition, cognition, emotional health, social context, geriatric syndromes, and chronic diseases. By incorporating multimorbidity and psychosocial domains alongside physical aspects, the Frailty-VIG provides a comprehensive assessment of frailty, overcoming the limitations of purely physical indices
5 secondary outcomes
Quality of life / Anxiety and Depression / Pain severity
Time frame: From enrollment to the end of treatment at 12 weeks
Sleep performance
Time frame: From enrollment to the end of treatment at 12 weeks
Physical activity
Time frame: From enrollment to the end of treatment at 12 weeks
Handgrip strength
Time frame: From enrollment to the end of treatment at 12 weeks
Inflammatory and mitochondrial function biomarkers
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dual task exercise and Otago exercise in people with Frail Elderly and Dual Task Exercises in Elderly People, run by Universitat de Lleida.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oriol Martínez-Navarro, Doctor (619562618, oriol.martinez@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical performance and functional status (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 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 3 Oct 2025.