FrailtyNCT07637890
Designing a Multicomponent Intervention for Improving Frailty. A Pilot Study in the Basque Country
A study testing Multi-component intervention: physical exercise, polypharmacy review and nutritional care in people with Frailty, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
Trial summary
This pilot study tested whether a new program for older adults with frailty could realistically be carried out in primary health care. That is why the main objective of this study was to evaluate the viability and feasibility of the newly designed frailty intervention. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Multi-component intervention: physical exercise, polypharmacy review and nutritional care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 23 Dec 2024to 25 Sep 2025
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- >65 years old
- Barthel >90 points (independent)
- Short Physical Performance Battery <10 points (frail)
Who cannot join
- Having a terminal condition
- Suffering from pathologies with a poor prognosis
- Having difficulty in performing physical activities
- Not being able to communicate fluently in Spanish
- Presenting intellectual disabilities
Trial locations and contacts
1 site in 1 country.
Spain1 site
Biogipuzkoa Health Research Institute. Primary Care Group. Epidemiology, Public Health and Primary Care Area.
San Sebastián, Gipuzkoa, 20014
About this study
This pilot study tested whether a new program for older adults with frailty could realistically be carried out in primary health care. That is why the main objective of this study was to evaluate the viability and feasibility of the newly designed frailty intervention.
People over 65 were recruited in two health centers and invited to join a 3 month program combining group exercise, a medication review by a pharmacist, and nutrition workshops. The study also collected information on mobility, strength, nutrition, mood, cognition, and quality of life. Most measures were taken at the start and again four and eight months later.
The results will help refine the program and guide the design of a larger clinical trial.
Read the detailed description
The study assessed the viability and feasibility of a frailty intervention in routine clinical practice through a prospective one-arm pilot conducted in two primary care centers in Donostia (Gipuzkoa, Basque Country, Spain). Participants were adults aged 65 or older, functionally independent (Barthel >90) and classified as frail (Short Physical Performance Battery <10), who received a 12-week physical exercise program, nutritional counseling, and a pharmacological review.
- Conditions
- Frailty
- Being tested
- Multi-component intervention: physical exercise, polypharmacy review and nutritional care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component intervention: physical exercise, polypharmacy review and nutritional careOther
Physical exercise: one-hour group sessions, twice a week for 12 consecutive weeks, at the Municipal Sports centre led by a licensed sports instructor. All sessions followed a standardized structure consisting of a warm-up phase of approximately 25 minutes, a strengthening phase of about 25 minutes adjusted to each participant's physical condition, and a final 10-minute relaxation phase including flexibility and balance exercises. Polypharmacy review: a primary care pharmacist reviewed the pharmacological treatments of each participant in order to detect potentially inappropriate prescriptions, following the STOPP/START criteria. Nutritional care: the dietary intervention consisted of three group workshops, one per month, lasting for an hour each. The three workshops, led by a nutritionist, covered the basics of healthy eating, dietary adaptations for specific conditions with recipe ideas, and strategies to prevent malnutrition and sarcopenia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: physical exercise, polypharmacy review and nutritional care | Experimental | The arm is composed of people aged >65, independent (≥95 points) and frail (Short Physical Performance Battery <10 points). The entire arm group receives the multi-component intervention based on physical exercise, polypharmacy review and nutritional care. Receives: Other: Multi-component intervention: physical exercise, polypharmacy review and nutritional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
The numbers of pre-selected participants who met the inclusion criteria and eventually agreed to participate, as well as the drop-outs and their reasons were registered.
Measured: Baseline
Time required to recruit the sample
The time required to recruit the sample needed for the study was recorded.
Measured: Baseline
Participants evaluation time
The professionals recorded the evaluation time each participant required
Measured: From baseline to 8 months
Professionals' opinion on the difficulty and adequacy of the process
Professionals who performed the baseline and follow-up assessments completed a questionnaire on the difficulty and adequacy of the process
Measured: From baseline to 8 months
Adherence to the intervention
Number of attended sessions was registered
Measured: From baseline to 4 months
Participant satisfaction
Satisfaction was measured with an anonymous ad-hoc questionnaire, containing a total of 25 questions: The physical exercise and the nutritional components were evaluated with six questions each; general health improvements obtained during the intervention with 11; two last questions asked about the intention to keep exercising after the intervention ended and whether they would recommend this program to others.
Measured: Month 4
Secondary outcomes (12)
Change from Baseline in Functional Capacity at 4 and 8 months
The Timed Up and Go (TUG) test was used to assess functional capacity. TUG is a simple functional assessment used to evaluate mobility, balance, and fall risk. Participants are timed while standing up from a chair, walking three meters, turning, returning, and sitting down. Shorter times (in seconds) indicate better functional mobility, while longer times suggest impaired performance.
Measured: From baseline to 8 months
Change from Baseline in Physical Activity at 4 and 8 months
Physical activity was assessed using the International Physical Activity Questionnaire (IPAQ). It is a standardized instrument used to assess physical activity performed during the previous seven days, including walking, moderate activity, vigorous activity, and sedentary behavior. The questionnaire applies Metabolic Equivalent of Task (MET) values to estimate weekly energy expenditure and classify participants into low, moderate, or high physical activity levels. The unit of measurement is MET.
Measured: From baseline to 8 months
Change from Baseline in Handgrip Strength at 4 and 8 months
Handgrip strength measured with a dynamometer. Three dominant hand consecutive measurement were taken per participant. The finally considered values per follow-up were the means of those three. The unit of measurement is kg.
Measured: From baseline to 8 months
Change from Baseline in Eating Habits at 4 and 8 months
The Predimed questionnaire is a validated 14-item tool used to assess adherence to the Mediterranean diet, by asking about key dietary habits. Its score oscillates between 0-14 points, with higher values indicating greater adherence.
Measured: From baseline to 8 months
Change from Baseline in Nutritional Status at 4 and 8 months
The 6-item Mini Nutritional Assessment-Short Form (MNA-SF) was applied to evaluate the nutritional status of patients. The Mini Nutritional Assessment (MNA) is an 18-item validated tool used to evaluate nutritional status in older adults. The unit of measurement is points.
Measured: From Baseline to 8 months
Change from Baseline in Blood tests at 4 months
Complete blood count, biochemistry (glucose, urea, creatinine, thyroid hormones, vitamins B12 and D, ions, iron profile), albumin, and C-reactive protein were collected.
Measured: Frome baseline to 4 months
Change from Baseline in Pharmacological treatments at 4 months
Change in the number of pharmacological treatments.
Measured: From Baseline to 4 months
Change from Baseline in the Health-related quality of life at 4 and 8 months
The Euroqol Visual Analog Scale (EQ-VAS) was used for assessing self-reported quality of life. It is a vertical 0-100 line measuring overall health "today", with 100 being the best possible health.
Measured: From baseline to 8 months
Change from Baseline in Cognitive Status at 4 and 8 months
The Abbreviated Mini-Mental State Examination (MMSE-Short Form) was performed to assess the global cognitive function of the participants. It evaluates orientation, memory, attention, and language in 21 items, and provides a rapid estimate of cognitive status, with lower scores indicating greater impairment.
Measured: From baseline to 8 months
Change from Baseline in Anxiety and Depression Status at 4 and 8 months
Anxiety and depression was determined by the Goldberg Anxiety and Depression Scale. A brief screening instrument used to identify symptoms of anxiety and depression in adults. It consists of two subscales with nine items each, and the total scores help detect individuals at risk of clinically relevant emotional distress. Lower values indicate less anxiety and depression.
Measured: From baseline to 8 months
Change from Baseline in Dependence at 4 and 8 months
Lawton instrumental activities of daily living based on 8 items, with higher values indicating more independence.
Measured: From Baseline to 8 months
Change from Baseline in Social Connectedness at 4 and 8 months
The Lubben Social Networks Scale is a brief, standardised tool used to assess social connectedness in older people. It measures the number and frequency of contacts within family and friends and the perception on the availability of support. The family and friends sub-scales account for a maximum of 15 points each, with the total scale score ranging from 0 to 30 points. Higher values indicate more social ties.
Measured: From baseline to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start23 Dec 2024
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637890
- Sponsor's protocol ID
- GUT-FRG-2024-11
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tao A, Ho KHM, Yang C, Chan HYL. Effects of non-pharmacological interventions on psychological outcomes among older people with frailty: A systematic review and meta-analysis. Int J Nurs Stud. 2023 Apr;140:104437. doi: 10.1016/j.ijnurstu.2023.104437. Epub 2023 Jan 14.
PubMed 36764033Sirikul W, Buawangpong N, Pinyopornpanish K, Siviroj P. Impact of multicomponent exercise and nutritional supplement interventions for improving physical frailty in community-dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2024 Nov 18;24(1):958. doi: 10.1186/s12877-024-05551-8.
PubMed 39558234Morin KH. Clarifying the Importance of Pilot Studies. J Nurs Educ. 2023 Sep;62(9):487-488. doi: 10.3928/01484834-20230712-03. Epub 2023 Sep 1. No abstract available.
PubMed 37672495Gutierrez-Valencia M, Izquierdo M, Cesari M, Casas-Herrero A, Inzitari M, Martinez-Velilla N. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-1444. doi: 10.1111/bcp.13590. Epub 2018 May 3.
PubMed 29575094Rashidi Pour Fard N, Amirabdollahian F, Haghighatdoost F. Dietary patterns and frailty: a systematic review and meta-analysis. Nutr Rev. 2019 Jul 1;77(7):498-513. doi: 10.1093/nutrit/nuz007.
PubMed 31038679Yang X, Li S, Xu L, Liu H, Li Y, Song X, Bao J, Liao S, Xi Y, Guo G. Effects of multicomponent exercise on frailty status and physical function in frail older adults: A meta-analysis and systematic review. Exp Gerontol. 2024 Nov;197:112604. doi: 10.1016/j.exger.2024.112604. Epub 2024 Oct 21.
PubMed 39426607Nan J, Duan Y, Wu S, Liao L, Li X, Zhao Y, Zhang H, Zeng X, Feng H. Perspectives of older adults, caregivers, healthcare providers on frailty screening in primary care: a systematic review and qualitative meta-synthesis. BMC Geriatr. 2022 Jun 3;22(1):482. doi: 10.1186/s12877-022-03173-6.
PubMed 35659258Rivas-Ruiz F, Machon M, Contreras-Fernandez E, Vrotsou K, Padilla-Ruiz M, Diez Ruiz AI, de Mesa Berenguer Y, Vergara I; Group GIFEA. Prevalence of frailty among community-dwelling elderly persons in Spain and factors associated with it. Eur J Gen Pract. 2019 Oct;25(4):190-196. doi: 10.1080/13814788.2019.1635113. Epub 2019 Oct 22.
PubMed 31637940O'Caoimh R, Sezgin D, O'Donovan MR, Molloy DW, Clegg A, Rockwood K, Liew A. Prevalence of frailty in 62 countries across the world: a systematic review and meta-analysis of population-level studies. Age Ageing. 2021 Jan 8;50(1):96-104. doi: 10.1093/ageing/afaa219.
PubMed 33068107
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing a Multicomponent Intervention for Improving Frailty. A Pilot Study in the Basque Country
- ClinicalTrials.gov ID
- NCT07637890
- Acronym / sponsor ID
- GUT-FRG-2024-11
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 10 Jun 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 pilot study tested whether a new program for older adults with frailty could realistically be carried out in primary health care. That is why the main objective of this study was to evaluate the viability and feasibility of the newly designed frailty intervention.
People over 65 were recruited in two health centers and invited to join a 3 month program combining group exercise, a medication review by a pharmacist, and nutrition workshops. The study also collected information on mobility, strength, nutrition, mood, cognition, and quality of life. Most measures were taken at the start and again four and eight months later.
The results will help refine the program and guide the design of a larger clinical trial.
Detailed description
The study assessed the viability and feasibility of a frailty intervention in routine clinical practice through a prospective one-arm pilot conducted in two primary care centers in Donostia (Gipuzkoa, Basque Country, Spain). Participants were adults aged 65 or older, functionally independent (Barthel >90) and classified as frail (Short Physical Performance Battery <10), who received a 12-week physical exercise program, nutritional counseling, and a pharmacological review.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: physical exercise, polypharmacy review and nutritional care | Experimental | Other: Multi-component intervention: physical exercise, polypharmacy review and nutritional careThe arm is composed of people aged >65, independent (≥95 points) and frail (Short Physical Performance Battery <10 points). The entire arm group receives the multi-component intervention based on physical exercise, polypharmacy review and nutritional care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- >65 years old
- Barthel >90 points (independent)
- Short Physical Performance Battery <10 points (frail)
Key exclusion criteria (5 listed)
- Having a terminal condition
- Suffering from pathologies with a poor prognosis
- Having difficulty in performing physical activities
- Not being able to communicate fluently in Spanish
- Presenting intellectual disabilities
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 |
|---|---|---|
| Multi-component intervention: physical exercise, polypharmacy review and nutritional carePhysical exercise: one-hour group sessions, twice a week for 12 consecutive weeks, at the Municipal Sports centre led by a licensed sports instructor. All sessions followed a standardized structure consisting of a warm-up phase of approximately 25 minutes, a strengthening phase of about 25 minutes adjusted to each participant's physical condition, and a final 10-minute relaxation phase including flexibility and balance exercises. Polypharmacy review: a primary care pharmacist reviewed the pharmacological treatments of each participant in order to detect potentially inappropriate prescriptions, following the STOPP/START criteria. Nutritional care: the dietary intervention consisted of three group workshops, one per month, lasting for an hour each. The three workshops, led by a nutritionist, covered the basics of healthy eating, dietary adaptations for specific conditions with recipe ideas, and strategies to prevent malnutrition and sarcopenia. | Other | Intervention: physical exercise, polypharmacy review and nutritional care |
Primary outcome
Recruitment rates
Time frame: Baseline
The numbers of pre-selected participants who met the inclusion criteria and eventually agreed to participate, as well as the drop-outs and their reasons were registered.
Time required to recruit the sample
Time frame: Baseline
The time required to recruit the sample needed for the study was recorded.
Participants evaluation time
Time frame: From baseline to 8 months
The professionals recorded the evaluation time each participant required
Professionals' opinion on the difficulty and adequacy of the process
Time frame: From baseline to 8 months
Professionals who performed the baseline and follow-up assessments completed a questionnaire on the difficulty and adequacy of the process
Adherence to the intervention
Time frame: From baseline to 4 months
Number of attended sessions was registered
Participant satisfaction
Time frame: Month 4
Satisfaction was measured with an anonymous ad-hoc questionnaire, containing a total of 25 questions: The physical exercise and the nutritional components were evaluated with six questions each; general health improvements obtained during the intervention with 11; two last questions asked about the intention to keep exercising after the intervention ended and whether they would recommend this program to others.
12 secondary outcomes
Change from Baseline in Functional Capacity at 4 and 8 months
Time frame: From baseline to 8 months
Change from Baseline in Physical Activity at 4 and 8 months
Time frame: From baseline to 8 months
Change from Baseline in Handgrip Strength at 4 and 8 months
Time frame: From baseline to 8 months
Change from Baseline in Eating Habits at 4 and 8 months
Time frame: From baseline to 8 months
Change from Baseline in Nutritional Status at 4 and 8 months
Time frame: From Baseline to 8 months
Change from Baseline in Blood tests at 4 months
Time frame: Frome baseline to 4 months
Change from Baseline in Pharmacological treatments at 4 months
Time frame: From Baseline to 4 months
Change from Baseline in the Health-related quality of life at 4 and 8 months
Time frame: From baseline to 8 months
Change from Baseline in Cognitive Status at 4 and 8 months
Time frame: From baseline to 8 months
Change from Baseline in Anxiety and Depression Status at 4 and 8 months
Time frame: From baseline to 8 months
Change from Baseline in Dependence at 4 and 8 months
Time frame: From Baseline to 8 months
Change from Baseline in Social Connectedness at 4 and 8 months
Time frame: From baseline to 8 months
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 12 Jun 2026.
- Background: PubMed 36764033Tao A, Ho KHM, Yang C, Chan HYL. Effects of non-pharmacological interventions on psychological outcomes among older people with frailty: A systematic review and meta-analysis. Int J Nurs Stud. 2023 Apr;140:104437. doi: 10.1016/j.ijnurstu.2023.104437. Epub 2023 Jan 14.
- Background: PubMed 39558234Sirikul W, Buawangpong N, Pinyopornpanish K, Siviroj P. Impact of multicomponent exercise and nutritional supplement interventions for improving physical frailty in community-dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2024 Nov 18;24(1):958. doi: 10.1186/s12877-024-05551-8.
- Background: PubMed 37672495Morin KH. Clarifying the Importance of Pilot Studies. J Nurs Educ. 2023 Sep;62(9):487-488. doi: 10.3928/01484834-20230712-03. Epub 2023 Sep 1. No abstract available.
- Background: PubMed 29575094Gutierrez-Valencia M, Izquierdo M, Cesari M, Casas-Herrero A, Inzitari M, Martinez-Velilla N. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-1444. doi: 10.1111/bcp.13590. Epub 2018 May 3.
- Background: PubMed 31038679Rashidi Pour Fard N, Amirabdollahian F, Haghighatdoost F. Dietary patterns and frailty: a systematic review and meta-analysis. Nutr Rev. 2019 Jul 1;77(7):498-513. doi: 10.1093/nutrit/nuz007.
- Background: PubMed 39426607Yang X, Li S, Xu L, Liu H, Li Y, Song X, Bao J, Liao S, Xi Y, Guo G. Effects of multicomponent exercise on frailty status and physical function in frail older adults: A meta-analysis and systematic review. Exp Gerontol. 2024 Nov;197:112604. doi: 10.1016/j.exger.2024.112604. Epub 2024 Oct 21.
- Background: PubMed 35659258Nan J, Duan Y, Wu S, Liao L, Li X, Zhao Y, Zhang H, Zeng X, Feng H. Perspectives of older adults, caregivers, healthcare providers on frailty screening in primary care: a systematic review and qualitative meta-synthesis. BMC Geriatr. 2022 Jun 3;22(1):482. doi: 10.1186/s12877-022-03173-6.
- Background: PubMed 31637940Rivas-Ruiz F, Machon M, Contreras-Fernandez E, Vrotsou K, Padilla-Ruiz M, Diez Ruiz AI, de Mesa Berenguer Y, Vergara I; Group GIFEA. Prevalence of frailty among community-dwelling elderly persons in Spain and factors associated with it. Eur J Gen Pract. 2019 Oct;25(4):190-196. doi: 10.1080/13814788.2019.1635113. Epub 2019 Oct 22.
- Background: PubMed 33068107O'Caoimh R, Sezgin D, O'Donovan MR, Molloy DW, Clegg A, Rockwood K, Liew A. Prevalence of frailty in 62 countries across the world: a systematic review and meta-analysis of population-level studies. Age Ageing. 2021 Jan 8;50(1):96-104. doi: 10.1093/ageing/afaa219.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component intervention: physical exercise, polypharmacy review and nutritional care in people with Frailty, run by Biogipuzkoa Health Research Institute 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 5 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 12 Jun 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?
Recruitment rates (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07637890, which also lists 9 linked publications.
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 12 Jun 2026.